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1. Grimm EA, Smid CM, Lee JJ, Tseng CH, Eton O, Buzaid AC: Unexpected cytokines in serum of malignant melanoma patients during sequential biochemotherapy. Clin Cancer Res; 2000 Oct;6(10):3895-903
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  • [Title] Unexpected cytokines in serum of malignant melanoma patients during sequential biochemotherapy.
  • Biochemotherapy, which combines traditional chemotherapy with immune modulating biologicals, produces an unexpectedly high response rate (>50%) in advanced melanoma patients.
  • We hypothesize that immunological mechanism(s) are responsible for the increased response rate, and particularly that macrophage activation is involved in tumor reduction.
  • Patients were randomized to receive chemotherapy, composed of cisplatin, vinblastine, and dacarbazine (CVD), or biochemotherapy, which is CVD followed by interleukin (IL)-2 and IFN-alpha2b (CVD-BIO).
  • Laboratory analysis was performed on sera from 41 patients from each arm.
  • Six of the nine biological responses (nitrite, neopterin, IFN-gamma, IL-6, soluble IL-2R, and IL-10) significantly (P < 0.0002) increased in the CVD-BIO patients but not in the CVD patients.
  • The increased IL-6 (P = 0.04) and IL-10 (P = 0.05) correlated with patient response, but only when the minor responders were included in the analysis.
  • A trend of higher increase in IL-6 and IL-10 in patients having clinical response was found, suggesting an incomplete Th2 pattern of cytokine elaboration.
  • These data show that macrophage activation does not appear to be critical in the response to CVD-BIO, but that IL-10 and IL-6 induced by the BIO component of the CVD-BIO were associated with tumor regression, and that their biology should be pursued further in the analysis of mechanism(s) of response.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Cyclophosphamide / administration & dosage. Cytokines / blood. Dacarbazine / administration & dosage. Interferon-alpha / therapeutic use. Interleukin-2 / therapeutic use. Melanoma / blood. Melanoma / drug therapy. Vincristine / administration & dosage
  • [MeSH-minor] Enzyme-Linked Immunosorbent Assay. Humans. Interleukin-10 / blood. Interleukin-6 / blood. Interleukins / blood. Macrophage Activation. Macrophages / metabolism. Neopterin / metabolism. Nitrites / metabolism. Radioimmunoassay. Random Allocation. Receptors, Interleukin-2 / metabolism. Recombinant Proteins. Time Factors. Tumor Necrosis Factor-alpha / metabolism

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  • (PMID = 11051235.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / NIH-CA-16672; United States / NCI NIH HHS / CA / P30 CA-166723; United States / NCI NIH HHS / CA / R01 CA-64906
  • [Publication-type] Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Cytokines; 0 / Interferon-alpha; 0 / Interleukin-2; 0 / Interleukin-6; 0 / Interleukins; 0 / Nitrites; 0 / Receptors, Interleukin-2; 0 / Recombinant Proteins; 0 / Tumor Necrosis Factor-alpha; 130068-27-8 / Interleukin-10; 5J49Q6B70F / Vincristine; 670-65-5 / Neopterin; 7GR28W0FJI / Dacarbazine; 8N3DW7272P / Cyclophosphamide; 99210-65-8 / interferon alfa-2b; CVD protocol
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2. Davis ID, Brady B, Kefford RF, Millward M, Cebon J, Skrumsager BK, Mouritzen U, Hansen LT, Skak K, Lundsgaard D, Frederiksen KS, Kristjansen PE, McArthur G: Clinical and biological efficacy of recombinant human interleukin-21 in patients with stage IV malignant melanoma without prior treatment: a phase IIa trial. Clin Cancer Res; 2009 Mar 15;15(6):2123-9
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  • [Title] Clinical and biological efficacy of recombinant human interleukin-21 in patients with stage IV malignant melanoma without prior treatment: a phase IIa trial.
  • PURPOSE: Human interleukin-21 (IL-21) is a class I cytokine that mediates activation of CD8(+) T cells, natural killer (NK) cells, and other cell types.
  • We report final clinical and biological results of a phase II study of recombinant human IL-21 (rIL-21) in patients with metastatic melanoma.
  • EXPERIMENTAL DESIGN: Open-label, single-arm, two-stage trial.
  • ELIGIBILITY CRITERIA: unresectable metastatic melanoma, measurable disease by Response Evaluation Criteria in Solid Tumors, no prior systemic therapy (adjuvant IFN permitted), adequate major organ function, good performance status, no significant autoimmune disease, and life expectancy at least 4 months.
  • PRIMARY OBJECTIVE: antitumor efficacy (response rate).
  • SECONDARY OBJECTIVES: safety, blood biomarkers, and generation of anti-rIL-21 antibodies. rIL-21 (30 microg/kg/dose) was administered by intravenous bolus injection in 8-week cycles (5 dosing days followed by 9 days of rest for 6 weeks and then 2 weeks off treatment).
  • RESULTS: Stage I of the study comprised 14 patients.
  • One confirmed complete response (CR) was observed, and as per protocol, 10 more patients were accrued to stage II (total n = 24: 10 female and 14 male).
  • Best tumor response included one confirmed CR and one confirmed partial response, both with lung metastases.
  • Treatment was overall well tolerated.
  • Biomarker analyses showed increases in serum soluble CD25, frequencies of CD25(+) NK and CD8(+) T cells, and mRNA for IFN-gamma, perforin, and granzyme B in CD8(+) T and NK cells.
  • CONCLUSIONS: rIL-21 administered at 30 microg/kg/d in 5-day cycles every second week is biologically active and well tolerated in patients with metastatic melanoma.
  • Confirmed responses, including one CR, were observed.
  • [MeSH-major] Interleukins / therapeutic use. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Female. Humans. Interleukin-2 Receptor alpha Subunit / blood. Male. Middle Aged. Neoplasm Staging. Recombinant Proteins / therapeutic use. T-Lymphocyte Subsets / immunology

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  • (PMID = 19276257.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interleukin-2 Receptor alpha Subunit; 0 / Interleukins; 0 / Recombinant Proteins; 0 / interleukin-21
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3. Weber JS, Zarour H, Redman B, Trefzer U, O'Day S, van den Eertwegh AJ, Marshall E, Wagner S: Randomized phase 2/3 trial of CpG oligodeoxynucleotide PF-3512676 alone or with dacarbazine for patients with unresectable stage III and IV melanoma. Cancer; 2009 Sep 1;115(17):3944-54
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  • [Title] Randomized phase 2/3 trial of CpG oligodeoxynucleotide PF-3512676 alone or with dacarbazine for patients with unresectable stage III and IV melanoma.
  • BACKGROUND: The primary objective of this phase 2 study was to assess the objective response rate (complete response [CR] + partial responses [PR]), by Response Evaluation Criteria in Solid Tumors, of PF-3512676, a CpG oligodeoxynucleotide, alone in 2 doses or in combination with dacarbazine (DTIC) in patients with unresectable stage IIIB/C or stage IV malignant melanoma, with the aim of selecting an arm to take forward to a phase 3 portion of the study.
  • METHODS: A total of 184 patients were randomized to 1 of 4 treatments: PF-3512676 10 mg (low dose), at 40 mg (high dose), 40 mg plus DTIC (850 mg/m(2)), or DTIC (850 mg/m(2)) alone.
  • RESULTS: The objective response rate (PR or CR, confirmed or unconfirmed) in the 40 mg + DTIC arm was 16% (7 patients) compared with 8% (3 patients) with DTIC alone.
  • One (2%) patient in the 10-mg and 0 patients in the 40-mg arms achieved an objective response.
  • Best response of CR or PR or stable disease (SD), with no minimum duration defined for SD, was achieved by 15 (33%) patients in the 40 mg + DTIC arm, 15 (38%) patients in the DTIC-only arm, 8 (17%) patients in the 10-mg arm, and 9 (20%) patients in the 40-mg arm.
  • The most frequently reported adverse events were classified as local injection site reactions or systemic flu-like symptoms, specifically fatigue, rigors, and pyrexia.
  • The modest objective response rates observed in all arms did not warrant continuation to the phase 3 portion of the study.
  • [MeSH-major] Dacarbazine / administration & dosage. Melanoma / drug therapy. Oligodeoxyribonucleotides / therapeutic use. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Cytokines / analysis. Female. Humans. Male. Middle Aged. Survival Analysis. Treatment Outcome

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  • (PMID = 19536884.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Cytokines; 0 / Oligodeoxyribonucleotides; 0 / ProMune; 7GR28W0FJI / Dacarbazine
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4. Ravaud A, Delaunay M, Chevreau C, Coulon V, Debled M, Bret-Dibat C, Courbon F, Gualde N, Nguyen Bui B: Granulocyte-macrophage colony-stimulating factor alone or with dacarbazine in metastatic melanoma: a randomized phase II trial. Br J Cancer; 2001 Nov 16;85(10):1467-71
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  • [Title] Granulocyte-macrophage colony-stimulating factor alone or with dacarbazine in metastatic melanoma: a randomized phase II trial.
  • The potential antitumoral effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) led us to evaluate GM-CSF alone or with dacarbazine (DTIC) in metastatic melanoma in first line randomized phase II.
  • Treatment was arm A: GM-CSF: 5 microg kg(-1), bid, 14 consecutive days every 21 days and arm B: GM-CSF: 5 microg kg(-1), bid, day 2 to day 19 every 21 days and DTIC: 800 mg m(-2), day 1 of each cycle.
  • 32 patients (pts) were included, 15 pts in arm A and 17 in arm B.
  • 9 had only one metastatic site.
  • The median number of cycles given was 2 in arm A and 3 in arm B. 100% and 89.4% of the planned dose of GM-CSF was given in arm A and arm B respectively.
  • No objective response was obtained.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Melanoma / secondary
  • [MeSH-minor] Adult. Aged. Dacarbazine / administration & dosage. Female. Granulocyte-Macrophage Colony-Stimulating Factor / administration & dosage. Humans. Male. Middle Aged. Survival Analysis. Treatment Outcome

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  • (PMID = 11720430.001).
  • [ISSN] 0007-0920
  • [Journal-full-title] British journal of cancer
  • [ISO-abbreviation] Br. J. Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] Scotland
  • [Chemical-registry-number] 7GR28W0FJI / Dacarbazine; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor
  • [Other-IDs] NLM/ PMC2363949
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5. Davis ID, Skrumsager BK, Cebon J, Nicholaou T, Barlow JW, Moller NP, Skak K, Lundsgaard D, Frederiksen KS, Thygesen P, McArthur GA: An open-label, two-arm, phase I trial of recombinant human interleukin-21 in patients with metastatic melanoma. Clin Cancer Res; 2007 Jun 15;13(12):3630-6
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  • [Title] An open-label, two-arm, phase I trial of recombinant human interleukin-21 in patients with metastatic melanoma.
  • We report a phase 1 study of recombinant human IL-21 in patients with surgically incurable metastatic melanoma.
  • The secondary objectives were to identify a dose response for various biomarkers in the peripheral blood, estimate the minimum biologically effective dose, determine the pharmacokinetics of IL-21, determine if anti-IL-21 antibodies were induced during therapy, and measure effects on tumor size according to Response Evaluation Criteria in Solid Tumors.
  • EXPERIMENTAL DESIGN: Open-label, two-arm, dose escalation trial of IL-21 administered by i.v. bolus injection at dose levels from 1 to 100 microg/kg using two parallel treatment regimens: thrice weekly for 6 weeks (3/wk) or three cycles of daily dosing for 5 days followed by 9 days of rest (5+9).
  • One partial tumor response observed after treatment with IL-21 for 2 x 6 weeks (3/wk) became complete 3 months later.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Interleukins / administration & dosage. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Dose-Response Relationship, Drug. Enzyme-Linked Immunosorbent Assay. Female. Granzymes / drug effects. Humans. Interleukin-2 Receptor alpha Subunit / blood. Interleukin-2 Receptor alpha Subunit / drug effects. Male. Maximum Tolerated Dose. Middle Aged. Perforin. Pore Forming Cytotoxic Proteins / drug effects. Recombinant Proteins / administration & dosage. Recombinant Proteins / adverse effects. Recombinant Proteins / pharmacokinetics

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  • (PMID = 17575227.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interleukin-2 Receptor alpha Subunit; 0 / Interleukins; 0 / Pore Forming Cytotoxic Proteins; 0 / Recombinant Proteins; 0 / interleukin-21; 126465-35-8 / Perforin; EC 3.4.21.- / Granzymes
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6. Yoshikawa H, Nakamoto Y, Ozawa T, Dickinson RM: A dog with osteosarcoma which metastasized to the eye months before metastasis to other organs. J Vet Med Sci; 2008 Aug;70(8):825-8
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  • A 9-year-old male Shih Tzu with osteosarcoma had a forelimb amputation and underwent chemotherapy.
  • During chemotherapy, the right eye was enucleated due to refractory glaucoma, and was diagnosed as anterior uveal malignant melanoma.
  • The dog lived for 4 months after the enucleation without treatment.

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  • (PMID = 18772558.001).
  • [ISSN] 0916-7250
  • [Journal-full-title] The Journal of veterinary medical science
  • [ISO-abbreviation] J. Vet. Med. Sci.
  • [Language] ENG
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Antineoplastic Agents
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7. Atkins MB, Hsu J, Lee S, Cohen GI, Flaherty LE, Sosman JA, Sondak VK, Kirkwood JM, Eastern Cooperative Oncology Group: Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol; 2008 Dec 10;26(35):5748-54
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  • [Title] Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group.
  • PURPOSE: Phase II trials with biochemotherapy (BCT) have shown encouraging response rates in metastatic melanoma, and meta-analyses and one phase III trial have suggested a survival benefit.
  • In an effort to determine the relative efficacy of BCT compared with chemotherapy alone, a phase III trial was performed within the United States Intergroup.
  • Treatment cycles were repeated at 21-day intervals for a maximum of four cycles.
  • Tumor response was assessed after cycles 2 and 4, then every 3 months.
  • The two study arms were well balanced for stratification factors and other prognostic factors.
  • Response rate was 19.5% for BCT and 13.8% for CVD (P = .140).
  • Median progression-free survival was significantly longer for BCT than for CVD (4.8 v 2.9 months; P = .015), although this did not translate into an advantage in either median overall survival (9.0 v 8.7 months) or the percentage of patients alive at 1 year (41% v 36.9%).
  • CONCLUSION: Although BCT produced slightly higher response rates and longer median progression-free survival than CVD alone, this was not associated with either improved overall survival or durable responses.
  • Considering the extra toxicity and complexity, this concurrent BCT regimen cannot be recommended for patients with metastatic melanoma.

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  • (PMID = 19001327.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / U10 CA027057; United States / NCATS NIH HHS / TR / UL1 TR000005; United States / NCI NIH HHS / CA / CA66636; United States / NCI NIH HHS / CA / CA80775; United States / NCI NIH HHS / CA / U10 CA021115; United States / NCI NIH HHS / CA / U10 CA180835; United States / NCI NIH HHS / CA / U10 CA014028; United States / NCI NIH HHS / CA / CA14028; United States / NCI NIH HHS / CA / U10 CA066636; United States / NCI NIH HHS / CA / U10 CA080775; United States / NCI NIH HHS / CA / U10 CA039229; United States / NCI NIH HHS / CA / CA39229; United States / NCI NIH HHS / CA / U10 CA032102; United States / NCI NIH HHS / CA / CA32102; United States / NCI NIH HHS / CA / CA38926; United States / NCI NIH HHS / CA / CA74811; United States / NCI NIH HHS / CA / U10 CA038926; United States / NCI NIH HHS / CA / U10 CA023318; United States / NCI NIH HHS / CA / CA27057; United States / NCI NIH HHS / CA / U10 CA074811; United States / NCI NIH HHS / CA / CA21115; United States / NCI NIH HHS / CA / CA23318; United States / NCI NIH HHS / CA / CA16116
  • [Publication-type] Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, Non-P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Interleukin-2; 0 / Recombinant Proteins; 5J49Q6B70F / Vincristine; 7GR28W0FJI / Dacarbazine; 8N3DW7272P / Cyclophosphamide; 99210-65-8 / interferon alfa-2b
  • [Other-IDs] NLM/ PMC2645104
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8. Kirsch A: Successful treatment of metastatic malignant melanoma with Viscum album extract (Iscador M). J Altern Complement Med; 2007 May;13(4):443-5
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  • [Title] Successful treatment of metastatic malignant melanoma with Viscum album extract (Iscador M).
  • BACKGROUND: Recent study results demonstrate possible clinical benefit from adjuvant treatment with a standardized mistletoe (Viscum album) extract in patients with malignant melanoma.
  • PATIENT AND METHOD: We present a male patient, currently 68 years of age, with one malignant melanoma at the upper part of the right arm since 1992, and another nodular melanoma at the left shoulder, first diagnosed in 1999.
  • After discovery of the second melanoma and surgical resection, the patient was exclusively treated with standardized mistletoe extract (Iscador, (R)M; Weleda AG, CH-Arlesheim, Switzerland).
  • COURSE OF THERAPY AND RESULTS: In June 1992, histologic analysis confirmed the presence of stage IA superficially spreading malignant melanoma with low infiltration of the papillary dermis in a skin excision sample from the upper part of the right arm.
  • In November 1999, another melanoma was surgically removed at the patient's right shoulder.
  • In this case, the histologic examination revealed nodular melanoma, stage IIA (pT3, pN0, M0).
  • Therapy with mistletoe extract was introduced shortly afterwards as the sole adjuvant treatment.
  • During the course of the mistletoe therapy, axillary removal of 8 lymph nodes became necessary, 3 of which proved to be metastatic.
  • First signs of a defined solitary liver metastasis in an area next to segments IV and V were detected during an abdominal ultrasound examination in September 2001.
  • This finding was confirmed by further sonographic examinations.
  • The solitary liver metastasis was not resected, nor was classical antitumor treatment (chemotherapy or radiotherapy) initiated.
  • The patient continued subcutaneous treatment with Iscador M after dose adaptation to 2 mg twice weekly (0.2 mL of a 10-mg vial); the treatment is still ongoing to the present.
  • CONCLUSIONS: The use of low-dose Iscador as the sole postoperative modality for the adjuvant treatment of metastatic melanoma was extremely effective and very well tolerated in this patient.
  • It achieved complete response and absence of all complaints.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Liver Neoplasms / drug therapy. Liver Neoplasms / secondary. Melanoma / drug therapy. Melanoma / secondary. Plant Extracts / administration & dosage. Plant Proteins / administration & dosage. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adjuvants, Pharmaceutic. Aged. Humans. Male. Treatment Outcome. Viscum album

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  • (PMID = 17532738.001).
  • [ISSN] 1075-5535
  • [Journal-full-title] Journal of alternative and complementary medicine (New York, N.Y.)
  • [ISO-abbreviation] J Altern Complement Med
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Pharmaceutic; 0 / Antineoplastic Agents; 0 / Plant Extracts; 0 / Plant Proteins; 0 / viscum album peptide
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9. Cocconi G, Passalacqua R, Foladore S, Carlini P, Acito L, Maiello E, Marchi M, Gebbia V, Di Sarra S, Beretta M, Bacchi M: Treatment of metastatic malignant melanoma with dacarbazine plus tamoxifen, or vindesine plus tamoxifen: a prospective randomized study. Melanoma Res; 2003 Feb;13(1):73-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Treatment of metastatic malignant melanoma with dacarbazine plus tamoxifen, or vindesine plus tamoxifen: a prospective randomized study.
  • This study aimed to verify whether the advantage in terms of response rate and survival of dacarbazine plus tamoxifen over dacarbazine alone in metastatic malignant melanoma reported in a previous randomized trial was due to a specific interaction of dacarbazine with tamoxifen.
  • A total of 125 patients with locoregional or disseminated malignant melanoma were randomized to receive dacarbazine (250 mg/m(2) days 1-5 every 3 weeks) plus tamoxifen (arm A) or vindesine (3 mg/m(2) every week for 6 weeks, then every 2 weeks) plus tamoxifen (arm B).
  • Of the 125 randomized patients, 57 and 59 were evaluable in arm A and B, respectively.
  • The complete response rates were the same (2% versus 2%) and the complete plus partial response rates were similar (11% versus 14%) in the two groups.
  • Neither response or survival correlated with gender.
  • In conclusion, when combined with tamoxifen, dacarbazine does not have a specific effect on response or survival compared with vindesine.
  • The lower response rate to dacarbazine plus tamoxifen (11%) than that reported in the previous trial (28%) might be explained by actual differences in patient and/or participating centre accrual characteristics in the presence of apparently identical eligibility criteria.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Dacarbazine / administration & dosage. Female. Humans. Male. Middle Aged. Neoplasm Recurrence, Local / drug therapy. Prospective Studies. Survival Rate. Tamoxifen / administration & dosage. Treatment Outcome. Vindesine / administration & dosage

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  • (PMID = 12569288.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 094ZI81Y45 / Tamoxifen; 7GR28W0FJI / Dacarbazine; RSA8KO39WH / Vindesine
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10. Hamid NA, Chandra A, Meyer CH: Multiple brain metastases from malignant melanoma with long-term survival. Br J Neurosurg; 2004 Oct;18(5):552-5
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  • [Title] Multiple brain metastases from malignant melanoma with long-term survival.
  • We present a case of multiple malignant melanoma metastases in the brain who is leading a normal life 16 years after the brain secondaries were managed by surgical resection, stereotactic radiation and chemotherapy.
  • The primary lesion in the left upper arm was excised 4 years prior to the brain metastases.
  • His most recent MRI shows him to be disease free.
  • To the best of our knowledge, this is longest survival reported of any patient with multiple brain metastases from malignant melanoma.
  • [MeSH-major] Brain Neoplasms / secondary. Melanoma / secondary
  • [MeSH-minor] Adult. Humans. Magnetic Resonance Imaging. Male. Prognosis. Radiosurgery. Skin Neoplasms / surgery

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  • (PMID = 15799166.001).
  • [ISSN] 0268-8697
  • [Journal-full-title] British journal of neurosurgery
  • [ISO-abbreviation] Br J Neurosurg
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] England
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11. Pawlik TM, Sondak VK: Malignant melanoma: current state of primary and adjuvant treatment. Crit Rev Oncol Hematol; 2003 Mar;45(3):245-64
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Malignant melanoma: current state of primary and adjuvant treatment.
  • Metastatic malignant melanoma remains a highly lethal disease with an incidence that continues to rise.
  • Management of melanoma includes definitive local, regional and distant control.
  • There is substantial prospective and retrospective data to base the extent of both primary as well as adjuvant therapy.
  • A critical assessment of the available information pertaining to the adjuvant treatment of cutaneous melanoma is needed.
  • This review provides a critical assessment of the current data that is available to guide both primary resection as well as adjuvant therapy.
  • To date, current trials have shown little promise with nonspecific immunostimulants and cytotoxic chemotherapy.
  • In contrast, dose interferon-alpha2b has been shown to improve relapse-free survival and likely improves melanoma-specific survival as well.
  • Based on the available data, interferon-alpha2b remains the adjuvant therapy of choice for high-risk patients treated outside clinical trials, and the appropriate control arm for clinical trials evaluating new or modified adjuvant regimens.
  • [MeSH-major] Melanoma / pathology. Melanoma / therapy
  • [MeSH-minor] Cancer Vaccines / immunology. Cancer Vaccines / therapeutic use. Chemotherapy, Adjuvant / methods. Combined Modality Therapy. Humans. Interferon-alpha / therapeutic use. Lymphatic Metastasis / diagnosis. Radiotherapy, Adjuvant / methods

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  • (PMID = 12633838.001).
  • [ISSN] 1040-8428
  • [Journal-full-title] Critical reviews in oncology/hematology
  • [ISO-abbreviation] Crit. Rev. Oncol. Hematol.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] Ireland
  • [Chemical-registry-number] 0 / Cancer Vaccines; 0 / Interferon-alpha
  • [Number-of-references] 151
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12. Tominaga R, Kohno H, Mayumi H, Shiraishi K, Nagae S, Nakayama J, Yasui H: Current techniques of hyperthermic isolated limb perfusion for malignant melanoma. Surg Today; 2000;30(4):339-42
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Current techniques of hyperthermic isolated limb perfusion for malignant melanoma.
  • A retrospective study was conducted examining 25 patients with malignant melanoma who were treated by our new protocol for hyperthermic isolated limb perfusion.
  • The characteristics of our techniques include: a lower priming volume of the extracorporeal circuit; a therapeutic temperature range of 40-41 degrees C with 60 min hyperthermic perfusion; a nominal perfusion flow rate of 500 ml/min in the lower limb and 200 ml/min in the upper limb; and combined carboplatin with interferon-beta as the adjuvant chemotherapy drug.
  • In the lower extremity group, the arterial cannula size ranged from 8 to 14 F, while the venous cannula size ranged from 14 to 16 F.
  • In the upper limb group, the arterial cannula size ranged from 6 to 8F and the venous cannula size ranged from 10 to 12F.
  • No operative death or major complications occurred during the early postoperative period, confirming the safety of this treatment.
  • Both optimal cannula size selection and maintaining perfusion temperature below 41 degrees C were judged to be important in elimination of vascular and deep tissue injury.
  • [MeSH-major] Chemotherapy, Cancer, Regional Perfusion / methods. Melanoma / therapy
  • [MeSH-minor] Adult. Aged. Antineoplastic Agents / therapeutic use. Carboplatin / therapeutic use. Combined Modality Therapy. Extracorporeal Circulation. Extremities. Female. Humans. Hyperthermia, Induced. Interferon-beta / therapeutic use. Lymph Node Excision. Male. Middle Aged. Retrospective Studies

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  • (PMID = 10795866.001).
  • [ISSN] 0941-1291
  • [Journal-full-title] Surgery today
  • [ISO-abbreviation] Surg. Today
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] JAPAN
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 77238-31-4 / Interferon-beta; BG3F62OND5 / Carboplatin
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13. Markovic S, Suman VJ, Dalton RJ, Woods JE, Fitzgibbons RJ Jr, Wold LE, Buckner JC, Kugler JW, Mailliard JA, Rowland KM, Krook JE, Brown DW, Tirona MT, Creagan ET: Randomized, placebo-controlled, phase III surgical adjuvant clinical trial of megestrol acetate (Megace) in selected patients with malignant melanoma. Am J Clin Oncol; 2002 Dec;25(6):552-6
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Randomized, placebo-controlled, phase III surgical adjuvant clinical trial of megestrol acetate (Megace) in selected patients with malignant melanoma.
  • A randomized, double-blind, placebo-controlled phase III clinical trial was performed to assess megestrol acetate (Megace) as a postsurgical adjuvant therapy for patients with locally advanced malignant melanoma.
  • Treatment was administered for a maximum of 2 years or until disease progression.
  • All but two patients were followed until death or a minimum of 4.5 years.
  • Disease progression was documented in 156 patients.
  • Neither progression-free survival (PFS) nor overall survival (OS) was found to differ between the treatments.
  • The median PFS was 2.4 years in the megestrol acetate arm and 2.3 years in the placebo arm.
  • Multivariate analysis revealed a significantly decreased PFS for patients with four or more positive regional lymph nodes and metachronous nodal disease.
  • Median OS was 5.3 years in the megestrol acetate arm and 3.9 years in the placebo arm.
  • Multivariate analysis revealed that OS was significantly decreased for patients 70 years of age or older with four or more positive lymph nodes.
  • Adjuvant therapy with megestrol acetate oral suspension administered at a dose of 160 mg twice a day for 2 years was not found to be effective in prolonging PFS or OS in patients with surgically resected, locally advanced melanoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Megestrol Acetate / therapeutic use. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Chemotherapy, Adjuvant. Double-Blind Method. Female. Humans. Lymphatic Metastasis. Male. Middle Aged. Multivariate Analysis. Survival Analysis

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  • (PMID = 12477996.001).
  • [ISSN] 0277-3732
  • [Journal-full-title] American journal of clinical oncology
  • [ISO-abbreviation] Am. J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA-15083; United States / NCI NIH HHS / CA / CA-25224; United States / NCI NIH HHS / CA / CA-35101; United States / NCI NIH HHS / CA / CA-35103; United States / NCI NIH HHS / CA / CA-35113; United States / NCI NIH HHS / CA / CA-35195; United States / NCI NIH HHS / CA / CA-35269; United States / NCI NIH HHS / CA / CA-35272; United States / NCI NIH HHS / CA / CA-35415; United States / NCI NIH HHS / CA / CA-35448; United States / NCI NIH HHS / CA / CA-37404; United States / NCI NIH HHS / CA / CA-37417; United States / NCI NIH HHS / CA / CA-52352; United States / NCI NIH HHS / CA / CA-60276; United States / NCI NIH HHS / CA / CA-63826; United States / NCI NIH HHS / CA / CA-63849
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; TJ2M0FR8ES / Megestrol Acetate
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14. Nicholson S, Guile K, John J, Clarke IA, Diffley J, Donnellan P, Michael A, Szlosarek P, Dalgleish AG: A randomized phase II trial of SRL172 (Mycobacterium vaccae) +/- low-dose interleukin-2 in the treatment of metastatic malignant melanoma. Melanoma Res; 2003 Aug;13(4):389-93
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A randomized phase II trial of SRL172 (Mycobacterium vaccae) +/- low-dose interleukin-2 in the treatment of metastatic malignant melanoma.
  • We conducted a randomized phase II trial of SRL172 (Mycobacterium vaccae) +/- low-dose interleukin-2 (IL-2) as treatment for stage IV malignant melanoma.
  • All patients had measurable metastatic disease and none received concurrent chemotherapy, radiotherapy, corticosteroids or any other investigational agent.
  • Sixteen patients were randomized into each arm of the trial prior to closure.
  • The trial was halted prematurely when no responses were seen in the first 16 patients receiving SRL172 alone, predicting a response rate of less than 20%.
  • These patients remained on monthly SRL172 + IL-2, with disease progression at 12, 15 and 23 months.
  • They continued on the trial regimen following surgical management of their disease progression.
  • This trial provides preliminary evidence of a new, non-toxic, immunotherapeutic regimen in the management of malignant melanoma.
  • Further trials are required to establish a definitive response rate and to compare the combination regimen with the regimen of low-dose IL-2 used in this trial.
  • A biological basis for the responses seen in the SRL172 + IL-2 arm also needs to be established.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Immunotherapy / methods. Melanoma / secondary. Melanoma / therapy. Skin Neoplasms / therapy
  • [MeSH-minor] Adjuvants, Immunologic / administration & dosage. Adult. Bacterial Vaccines / administration & dosage. Disease-Free Survival. Humans. Interleukin-2 / administration & dosage. Middle Aged. Mycobacterium / immunology. Treatment Outcome

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  • (PMID = 12883365.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Evaluation Studies; Journal Article; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Bacterial Vaccines; 0 / Interleukin-2; 0 / SRL172
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15. Feun LG, Savaraj N, Hurley J, Marini A, Lai S: A clinical trial of intravenous vinorelbine tartrate plus tamoxifen in the treatment of patients with advanced malignant melanoma. Cancer; 2000 Feb 1;88(3):584-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A clinical trial of intravenous vinorelbine tartrate plus tamoxifen in the treatment of patients with advanced malignant melanoma.
  • BACKGROUND: The aim of the current trial was to assess the efficacy and toxicity of weekly intravenous vinorelbine tartrate with daily oral tamoxifen in the treatment of patients with advanced or metastatic malignant melanoma.
  • METHODS: Thirty-one patients were treated with vinorelbine tartrate, 30 mg/m(2) intravenously, weekly every 13 weeks and then every 2 weeks thereafter until progression of disease or severity of toxicity warranted discontinuation.
  • Tamoxifen, 10 mg orally, twice a day was administered daily starting on Day 1 of chemotherapy with vinorelbine tartrate.
  • Thirty patients had cutaneous melanoma with metastases and 1 patient had ocular melanoma with metastases.
  • Eight patients had received prior chemotherapy.
  • RESULTS: Of the 30 evaluable patients with cutaneous melanoma, 6 achieved a partial response, for an overall response rate of 20% (95% confidence interval, 7-38%).
  • There was no response in the patient with ocular melanoma.
  • Major sites of response include the adrenal gland, lung, tonsil, and cutaneous/subcutaneous tissues.
  • Three patients had a prolonged duration of response lasting > or = 12 months.
  • Nonhematologic toxicity included mild fatigue, paresthesia, and local arm discomfort from infusion.
  • CONCLUSIONS: Weekly intravenous vinorelbine tartrate plus daily oral tamoxifen appears to be active in the treatment of patients with malignant melanoma.
  • Further clinical trials in malignant melanoma patients treated with vinorelbine tartrate and tamoxifen appear warranted.
  • [MeSH-major] Antineoplastic Agents, Hormonal / administration & dosage. Antineoplastic Agents, Phytogenic / administration & dosage. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Tamoxifen / administration & dosage. Vinblastine / analogs & derivatives
  • [MeSH-minor] Administration, Oral. Adult. Aged. Confidence Intervals. Disease Progression. Eye Neoplasms / drug therapy. Eye Neoplasms / pathology. Fatigue / chemically induced. Female. Follow-Up Studies. Humans. Infusions, Intravenous / adverse effects. Male. Middle Aged. Neoplasm Staging. Pain / chemically induced. Paresthesia / chemically induced. Remission Induction

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  • [Copyright] Copyright 2000 American Cancer Society.
  • (PMID = 10649251.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Hormonal; 0 / Antineoplastic Agents, Phytogenic; 094ZI81Y45 / Tamoxifen; 5V9KLZ54CY / Vinblastine; Q6C979R91Y / vinorelbine
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16. Wong SF, Jakowatz JG, Taheri R: Potential drug-drug interaction between interferon alfa-2b and gemfibrozil in a patient with malignant melanoma. Clin Ther; 2005 Dec;27(12):1942-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Potential drug-drug interaction between interferon alfa-2b and gemfibrozil in a patient with malignant melanoma.
  • BACKGROUND: In the United States, patients with high-risk stage II or III melanoma are often treated with adjuvant interferon (IFN) therapy for 1 year after surgery.
  • However, hypertriglyceridemia requiring treatment has been reported.
  • OBJECTIVE: The aim of this report was to describe a potential drug-drug interaction between IFN alfa-2b and gemfibrozil in a patient with malignant melanoma.
  • The possible mechanism of this potential interaction was examined.
  • METHODS: This report presents the case of a 43-year-old male patient weighing 101 kg with newly diagnosed stage III melanoma of the left arm, with metastasis to the supraclavicular node.
  • The patient presented to the University of California Irvine Medical Center, Orange, California with severe gastrointestinal (GI) symptoms and elevated hepatic enzyme concentrations at week 48 of 104 of adjuvant treatment of malignant melanoma (IFN alfa 11 MU SC TIW in combination with the investigational melanoma vaccine melanoma theraccine 1.25 mL [I mL lysate + 0.25 mL vaccine adjuvant] given SC at weeks 1, 2, 3, 4, 8, 16, 24, 32, 40, and 48 and then every 8 weeks until week 104), and IFN-induced hypertriglyceridemia (gemfibrozil 600 mg PO BID).
  • The patient had no history of cardiovascular or GI disease and was not receiving any concomitant medication.
  • The possible mechanism of this potential IFN alfa-gemfibrozil interaction as related to the cytochrome P450 (CYP) enzyme system was assessed.
  • RESULTS: In this case of a possible drug-drug interaction between IFN alfa 11 MU TIW and gemfibrozil 600 mg BID in a patient undergoing treatment for IFN-induced hypertriglyceridemia, the Naranjo Adverse Drug Reactions (ADR) Probability Scale score was 7 (ie, ADR possibly related to treatment).
  • A possible drug-drug interaction between IFN alfa 11 MU TIW and gemfibrozil 600 mg BID was reported in a patient undergoing treatment for IFN-induced hypertriglyceridemia.
  • [MeSH-major] Antineoplastic Agents / adverse effects. Gemfibrozil / adverse effects. Hypertriglyceridemia / drug therapy. Hypolipidemic Agents / adverse effects. Interferon-alpha / adverse effects
  • [MeSH-minor] Adult. Chemotherapy, Adjuvant / adverse effects. Drug Interactions. Humans. Lymphatic Metastasis. Male. Melanoma / drug therapy. Recombinant Proteins. Skin Neoplasms / drug therapy

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  • (PMID = 16507380.001).
  • [ISSN] 0149-2918
  • [Journal-full-title] Clinical therapeutics
  • [ISO-abbreviation] Clin Ther
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Hypolipidemic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 99210-65-8 / interferon alfa-2b; Q8X02027X3 / Gemfibrozil
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17. Hersh EM, Weber J, Powderly J, Yellin M, Kahn K, Pavlick A, Samlowski W, Nichol G, O'Day S: A phase II, randomized multi-center study of MDX-010 alone or in combination with dacarbazine (DTIC) in stage IV metastatic malignant melanoma. J Clin Oncol; 2004 Jul 15;22(14_suppl):7511

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II, randomized multi-center study of MDX-010 alone or in combination with dacarbazine (DTIC) in stage IV metastatic malignant melanoma.
  • : 7511 Background: MDX-010 is a human anti-CTLA-4 IgG1 monoclonal antibody that blocks CTLA-4 and augments immune responses.
  • In stage IV melanoma patients MDX-010 given with a gp100 vaccine demonstrated responses that correlated with autoimmune toxicity (Autoimmune Breakthrough Events; ABEs).
  • The current study determined the safety and activity of MDX-010 alone or with dacarbazine in Stage IV melanoma.
  • METHODS: 76 patients were enrolled and 72 received drug.
  • Patients were randomized to receive MDX-010, 3 mg/kg monthly × 4 (arm A; n=37) or MDX-010 in combination with dacarbazine 250 mg/m<sup>2</sup> for 5 days monthly × 4 (arm B; n=35).
  • Responses were determined after 4 treatments.
  • RESULTS: The study arms were well balanced.
  • There were five Grade III ABEs in arm A; colitis (n=2), uveitis (n=2) and rash (n=1).
  • There were six Grade III/IV ABEs in arm B; Grade III diarrhea/colitis (n=2), Grade III rash (n=2), Grade III increased ALT (n=1), and Grade IV hypersensitivity reaction (n=1).
  • All ABEs but 1 resolved with treatment.
  • One arm B patient had colitis complicated by C. difficile requiring colectomy.
  • Restaging data is currently available on 32 and 29 patients in arm A and B, respectively.
  • Two PRs occurred in arm A and 1CR and 4PRs occurred in arm B.
  • Four patients in arm A and 5 patients in arm B had SD (30-224+ days).
  • This study suggests that combination therapy with dacarbazine may have greater clinical activity than monotherapy in patients with Stage IV melanoma.
  • Future clinical trials of MDX-010 in combination with melanoma vaccines and chemotherapy are being planned.

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  • (PMID = 28014885.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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18. Liu D, O'Day SJ, Yang D, Boasberg P, Milford R, Kristedja T, Groshen S, Weber JS: Immune gene polymorphisms predict overall survival for stage IV melanoma patients treated with biochemotherapy. J Clin Oncol; 2004 Jul 15;22(14_suppl):7550

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Immune gene polymorphisms predict overall survival for stage IV melanoma patients treated with biochemotherapy.
  • : 7550 Background: Although high response rates have been shown using biochemotherapy regimens for stage IV melanoma, median survival is less than one year and the regimen is not clearly superior to chemotherapy alone.
  • We hypothesized that single nucleotide polymorphisms (SNPs) may impact on the clinical outcome for patients treated with biochemotherapy and predict those likely to benefit from this therapy.
  • METHODS: SNP of immune genes (IFN-γ promoter +874, IL-10 -1082, and IL-8 -521) were analyzed by PCR-RFLP and ARMS-PCR from 90 patients with Stage IV melanoma treated with a biochemotherapy regimen (Cisplatinum, Vinblastine, Dacarbazine, IL-2 and IFN-α either with or without Tamoxifen).
  • CONCLUSIONS: Individual immune SNPs predicted clinical outcome for advanced melanoma patients who received biochemotherapy, and might be useful to select patients more likely to benefit from this treatment.
  • The combined effects of immune-associated polymorphisms and those encoding DNA repair genes (Liu et al, 2003 submitted) may impact on the outcome of biochemotherapy and allow selection of appropriate candidates for this therapy.

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  • (PMID = 28015897.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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19. Saunders M, Anthoney A, Coffey M, Mettinger K, Thompson B, Melcher A, Nutting CM, Harrington K: Results of a phase II study to evaluate the biological effects of intratumoral (ITu) reolysin in combination with low dose radiotherapy (RT) in patients (Pts) with advanced cancers. J Clin Oncol; 2009 May 20;27(15_suppl):e14514

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Results of a phase II study to evaluate the biological effects of intratumoral (ITu) reolysin in combination with low dose radiotherapy (RT) in patients (Pts) with advanced cancers.
  • : e14514 Background: Reolysin, a wild type reovirus serotype 3 Dearing strain, replicates preferentially in Ras-activated cancer cells.
  • A completed phase I trial of ITu reolysin and RT demonstrated that the combination was well tolerated and resulted in local and systemic responses.
  • METHODS: This open-label, single-arm, multicenter Phase 2 study combined ITu reolysin with low-dose fractionated RT.
  • 20 Gy was given in 5 consecutive daily 4 Gy fractions combined with 2 ITu injections of reolysin (1x10<sup>10</sup> TCID<sub>50</sub>) on days 2 & 4.
  • The primary endpoint was objective tumor response rate in treated lesions.
  • Secondary endpoints were to evaluate: viral replication, immune response and safety.
  • Pts with ECOG performance status ≤2, with refractory advanced or metastatic cancers were eligible.
  • RESULTS: 16 heavily pre-treated pts (9 male, median age 66 yrs, ECOG 0:4pts; 1:12pts) with advanced cancer: melanoma (5), colorectal (4), gastric (1), ovarian (1), pancreas (1), lung (1), cholangiocarcinoma (1), sinus (1), and thyroid (1) were enrolled since Dec 2006.
  • Most pts had received prior chemotherapy (13 pts) or RT (5 pts).
  • Toxicities related to treatment were Grade 1 or 2: chills, pyrexia, headache, lethargy, anorexia, vomiting, shivering, nausea, and mild injection site pain.
  • Of 14 pts evaluable for response, 13 pts had stable disease or better in the treated target lesion.
  • Of these, partial responses were observed in 4 pts (lung, melanoma x 2, gastric) and minor responses were observed in 2 pts (thyroid, ovarian).
  • Antibody responses to reolysin were delayed compared to previous results with intravenous administration.
  • CONCLUSIONS: The combination of ITu reolysin and low dose RT was well tolerated and resulted in marked responses or stabilization in the treated target lesions for most of the pts evaluated to date.

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  • (PMID = 27963520.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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20. Schadendorf D, Nestle FO, Broecker EB, Enk A, Grabbe S, Ugurel S, Edler L, Schuler G, DeCOG-DC Study Group: Dacarbacine (DTIC) versus vaccination with autologous peptide-pulsed dendritic cells (DC) as first-line treatment of patients with metastatic melanoma: Results of a prospective-randomized phase III study. J Clin Oncol; 2004 Jul 15;22(14_suppl):7508

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Dacarbacine (DTIC) versus vaccination with autologous peptide-pulsed dendritic cells (DC) as first-line treatment of patients with metastatic melanoma: Results of a prospective-randomized phase III study.
  • : 7508 Background: Progress in the treatment of patients with metastatic melanoma has been very limited over the last two decades.
  • METHODS: Patients with advanced metastatic melanoma, HLA-A1, -A2, -A3, -A24 or -B44 positivity, no brain or bone metastases and any previous systemic chemotherapy were randomised to receive DTIC (850 mg/m<sup>2</sup> d<sub>1</sub>, every 28 days with 4-week intervals (arm A) or intradermal vaccination with autologous peptide-pulsed dendritic cells in 2-week intervals for the first 5 vaccinations and every 4 weeks thereafter (arm B).
  • DC were generated from peripheral blood after leukapheresis and culturing monocytes in-vitro in GM-CSF, IL-4 (d1-d5) and a maturing cytokine cocktail (IL-1β, IL-6, TNFα and PGE<sub>2</sub>) on day 6.
  • Matured DC were pulsed subsequently with peptides derived from MAGE-1, MAGE-3, Melan-A, gp100, tyrosinase and influenza proteins as a control depending on the individual HLA-type (d6).
  • Primary study endpoint was objective response to treatment (OR), secondary endpoints included safety, overall and progression-free survival.
  • The planned accrual per arm was set at 119 patients under the basic assumption that the response rate would double from 15 % for treatment with DTIC to 30 % for DC-vaccination to reach significance at 0.05 with 80% power.
  • RESULTS: In the time period between 1/2001 and 6/2003 a total of 108 (intention-to-treat population, ITT; 55 DTIC, 53 DC) patients were randomized from 1 Swiss and 5 German centers with experience in DC generation and therapy.
  • OR (CR+PR) were 5.5% in arm A and 3.8% in arm B, respectively (ITT).
  • There was no statistically significant difference for response, toxicity, overall and progression-free survival between both study arms.
  • Subset analysis indicated a trend for benefical effect of HLA-A2 and a disadvantage for HLA-B44.
  • CONCLUSION: DC-based vaccination is as poorly active as standard DTIC chemotherapy in metastatic melanoma.

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  • (PMID = 28014897.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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21. Zatloukal P, Heo DS, Park K, Kang J, Butts C, Bradford D, Graziano S, Huang B, Healey D: Randomized phase II clinical trial comparing tremelimumab (CP-675,206) with best supportive care (BSC) following first-line platinum-based therapy in patients (pts) with advanced non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):8071

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Randomized phase II clinical trial comparing tremelimumab (CP-675,206) with best supportive care (BSC) following first-line platinum-based therapy in patients (pts) with advanced non-small cell lung cancer (NSCLC).
  • : 8071 Background: Pts diagnosed with advanced NSCLC with good performance status typically receive platinum-based chemotherapy; however, no approved maintenance therapy exists.
  • Tremelimumab, a fully human anti-CTLA4 mAb, is associated with durable responses in some pts with metastatic melanoma.
  • METHODS: This open-label, randomized, multicenter, phase II clinical trial evaluating efficacy and safety of tremelimumab as maintenance therapy was conducted in pts with locally advanced or metastatic NSCLC with ECOG performance status ≤1.
  • Pts treated with ≥4 cycles of first-line platinum-based therapy resulting in either stable disease (SD) or response per RECIST were eligible and were randomized 3-6 weeks after prior therapy.
  • Pts received 15 mg/kg IV tremelimumab Q90D or BSC until disease progression.
  • Primary endpoint was progression-free survival (PFS) at 3 months.
  • Secondary endpoints included safety, objective response rate, and 1-year survival.
  • Nine (20.9%; 90% CI: 11.4%, 33.7%) pts receiving tremelimumab and 6 (14.3%; 90% CI: 6.4%, 26.3%) pts receiving BSC were progression free at 3 months.
  • Among pts receiving tremelimumab, there were 2 (4.8%) partial responses and 7 (16.6%) SDs, compared with 0 and 6 (14.3%) pts receiving BSC, respectively.
  • Treatment-related adverse events (AEs) were observed in 27 (61.4%) pts receiving tremelimumab and 3 (7.0%) receiving BSC.
  • CONCLUSIONS: In pts with advanced NSCLC and good performance status receiving platinum-based first-line therapy, single-agent tremelimumab was tolerable, with safety consistent with prior studies.
  • Although PFS analysis did not demonstrate superiority of tremelimumab over BSC, the 4.8% objective response rate seen only in the investigational arm may support future combination studies.
  • Analysis of 1-year survival is forthcoming.

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  • (PMID = 27962647.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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22. Pavlick AC, Millward M, Farrell K, Hamilton A, Broseus A, Haas N, Shore T, Jacquotte A, Colevas D, Muggia F: A phase II study of epothilone B analog (EpoB)-BMS 247550 (NSC#710428) in stage IV malignant melanoma (MM). J Clin Oncol; 2004 Jul 15;22(14_suppl):7542

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II study of epothilone B analog (EpoB)-BMS 247550 (NSC#710428) in stage IV malignant melanoma (MM).
  • : 7542 Background: EpoB is a new non-taxane microtubule binding agent that leads to mitotic arrest.
  • METHODS: Eligibility: Stage IV MM patients, treated and stable brain mets allowed, ECOG performance status 0-2, adequate hematologic and organ function, no pre-existing grade 2-4 peripheral neuropathy.
  • Pts were stratified into previously untreated and prior therapy groups.
  • Responses were evaluated every 2 cycles.
  • Primary endpoint: Response rate (RR).
  • Secondary endpoint: Time to progression (TTP).
  • The inevaluable patient (no prior therapy) developed neurtopenic, septic shock after the first cycle of therapy and died.
  • No responses were seen in either arm (RR=0,CI=95%).
  • 5 patients received 3-6 cycles and had stable disease, but were removed due to toxicity. (Median TTP= 8 weeks).

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  • (PMID = 28015922.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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23. Combs D, Baker A, Fu J, Herring A, Jeter J, Cranmer L: Feasibility study of neurocognitive assessment of melanoma patients treated with adjuvant interferon. J Clin Oncol; 2009 May 20;27(15_suppl):e20567

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Feasibility study of neurocognitive assessment of melanoma patients treated with adjuvant interferon.
  • : e20567 Background: Interferon α-2b (IFN) is the only approved adjuvant therapy for patients diagnosed with high-risk melanoma.
  • Cognitive and mood alterations have been consistently reported during IFN therapy.
  • METHODS: We enrolled patients with at least stage 2B melanoma who were eligible to receive adjuvant IFN.
  • Controls were those IFN-eligible, but not receiving it or those with unresectable melanoma eligible to receive dacarbazine-based chemotherapy (DTIC).
  • Six cognitive function tests were administered: mini-mental status exam (MMSE), Hopkins Verbal Learning Test-Revised (HVLT), controlled oral word association, Ruff 2 and 7 (R27), Trail Making Tests A and B, and the Profile of Mood States-Short Form (POMS).
  • Test results were compared at baseline and after the high-dose phase of IFN, 1-3 months of observation, or first cycle of chemotherapy.
  • Fourteen patients (4 IFN, 8 Obs., 2 DTIC) were seen for a total of 26 testing visits.
  • Based on our HVLT data, a total of 17 subjects per arm are required to demonstrate a statistically significant difference (alpha=0.05, beta=0.10).
  • CONCLUSIONS: Our pilot results indicate that administration of this test battery is feasible in this population and is a promising tool to quantify adverse cognitive effects of IFN therapy.

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  • (PMID = 27961131.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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24. El-Maraghi R, Verma S, Charette M, Markman B, Quirt I, Melanoma Disease Site Group (MDSG) of the Cancer Care Ontario Program In Evidence-Based Care: A meta-analysis of biochemotherapy (BCT) for the treatment of metastatic malignant melanoma (MM). J Clin Oncol; 2004 Jul 15;22(14_suppl):7529

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A meta-analysis of biochemotherapy (BCT) for the treatment of metastatic malignant melanoma (MM).
  • : 7529 Background: Systemic approaches to therapy of metastatic MM include cytotoxic chemotherapy, immunotherapy such as interferon-alpha (IFN) and interleukin-2 (IL-2), and more recently BCT.
  • METHODS: A systematic review of the literature regarding BCT for treatment of metastatic MM was conducted using MEDLINE, CANCERLIT, Cochrane Library and Physician Data Query clinical trials databases.
  • Relevant articles and abstracts were selected and reviewed by one member of the MDSG and methodologists.
  • All published reports including abstracts for randomized controlled trials (RCTs) and single-arm phase II trials involving BCT were considered.
  • An estimate of the effect of BCT on overall response rate (ORR), time to progression (TTP) and overall survival (OS) was determined using pooled data from published reports of individual RCTs.
  • RESULTS: Nine RCTs, 8 randomized phase II trials and 39 single-arm phase II trials were identified.
  • Six studies compared chemotherapy alone to chemotherapy plus IL-2 and IFN.
  • In only one study, BCT was superior for ORR (48% vs. 25%, p=0.001) and median survival (11.9 vs. 9.2 months, p=0.06) while a second demonstrated an improved ORR (44% vs. 27%, p=0.071) but a lower median survival (10.7 vs. 15.8 months, p=0.052).
  • The remaining four studies showed no significant differences in ORR, TTP or OS.
  • A pooled meta-analysis demonstrated that BCT was superior to chemotherapy for ORR (relative risk (RR)=1.49, CI 1.21-1.83, p=0.0002), and delayed TTP at six months (RR=0.82, CI 0.72-0.94, p=0.004) but not one-year survival (RR=0.89, CI 0.77-1.03, p=0.13).
  • Therapy was toxic but quality of life did not seem to be impaired.
  • CONCLUSIONS: BCT is associated with higher ORR compared to standard therapy but does not have a meaningful impact on survival in patients with metastatic MM.
  • Due to the toxicity of BCT, treatment should be restricted to experienced centres.

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  • (PMID = 28014936.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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25. Pavlick AC, Ott P, Escalon J, Madden K, Yepes E, Staha J, Mendoza S, Gandhi A, Yee H, Liebes L: Survival of advanced melanoma patients with normal LDH treated with oblimersen, temozolomide, and nab-paclitaxel. J Clin Oncol; 2009 May 20;27(15_suppl):9080

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Survival of advanced melanoma patients with normal LDH treated with oblimersen, temozolomide, and nab-paclitaxel.
  • : 9080 Background: Oblimersen (OBL), temozolomide (TMZ), and abraxane (ABX) act synergistically in preclinical studies with melanoma cell lines.
  • Bcl-2 antisense therapy in combination with dacarbazine was encouraging in advanced melanoma patients(pts) with normal LDH.
  • METHODS: Chemotherapy-naïve advanced melanoma pts (ECOG PS ≤ 2, baseline LDH ≤1.1 × ULN, measurable disease per RECIST) were enrolled on a phase I/II protocol.
  • The treatment regimen consisted of 56-day cycles of OBL (7 mg/kg/d continuous IV infusion, d 1-7 and 22-28), TMZ (75 mg/m<sup>2</sup>/d, d 1-42), and ABX (175 mg/m<sup>2</sup> in Cohort 1, 260 mg/m<sup>2</sup> in Cohort 2, d 7 and 28).
  • Immunohistochemical (IHC) staining for Bcl-2, Bcl-XL, BAK and caspase 3 was performed in pre- and post-therapy tumor samples.
  • Disease sites included liver (6), other visceral sites (10), skin, subcutaneous tissue, and lymph nodes (2).
  • The overall survival (OS) was 14.7 months and showed a trend towards superiority when compared to both arms of the prior oblimersen trial (DTIC, OS 9.7 months, p = 0.078 and DTIC-OBL, OS 11.4 months, p = 0.31) in pts with the same LDH cut-off (Bedikian et al. JCO. 2006).
  • One CR lasted 25+ mo, five PR (>50% tumor reduction) lasted > 2 cycles, and 7 SD lasted > 3 cycles.
  • One ocular melanoma pt survived 15 mo despite PD.
  • Shed cryptic epitopes correlated with clinical response versus disease progression.
  • Alteration of the tumor biology based on phenotypic changes in Bcl-2, Bcl-xL, BAK and caspase 3 correlated with response to treatment.
  • CONCLUSIONS: Our data suggest that the combination of OBL, TMZ, and ABX is synergistic in advanced melanoma pts with normal LDH, possibly translating into improved OS compared to prior regimens with dacarbazine ± OBL.
  • Biomarker studies support the rationale that Bcl-2 antisense therapy specifically impacts apoptotic signaling pathways in melanoma cells from metastatic tumor.
  • The survival data in the limited number of pts enrolled in cohort 1 and 2 of this trial are encouraging; further exploration with this combination is underway using 1-hour infusions of OBL.

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  • (PMID = 27962199.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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26. O'Day SJ, Agarwala SS, Naredi P, Kass CL, Gehlsen KR, Glaspy J: Treatment with histamine dihydrochloride and interleukin-2 in patients with advanced metastatic malignant melanoma: a detailed safety analysis. Melanoma Res; 2003 Jun;13(3):307-11
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Treatment with histamine dihydrochloride and interleukin-2 in patients with advanced metastatic malignant melanoma: a detailed safety analysis.
  • Intravenous high dose bolus therapy with interleukin-2 (IL2) is associated with low overall response rates (15%) and significant toxicity.
  • Phase II and III trials of a lower dose subcutaneous regimen of IL2 administered alone (n = 152) or in combination with histamine dihydrochloride (n = 239) have recently been completed.
  • The phase III trial demonstrated a survival benefit in patients with liver metastases in the histamine/IL2 arm.
  • Eligible patients had stage IV malignant melanoma with at least one measurable lesion.
  • Toxicity was graded using the National Cancer Institute (NCI) common toxicity scale.
  • Almost all toxicities in each treatment group were NCI grade 1 or 2.
  • The incidence of toxicities expected to occur with histamine treatment, such as hypotension/vasodilation, headache and injection site reaction, were higher among patients receiving histamine.
  • With the exception of headache, the incidence of grade 3 or 4 toxicities was similar across the treatment groups.
  • The addition of histamine to the subcutaneous IL2 regimen did not result in a difference in the incidence of drug interruption, dose modification or discontinuation.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / adverse effects. Asthenia / chemically induced. Chills / chemically induced. Fever / chemically induced. Melanoma / drug therapy. Melanoma / secondary. Skin Neoplasms / drug therapy. Vasodilation / drug effects
  • [MeSH-minor] Adolescent. Adult. Aged. Female. Histamine / administration & dosage. Humans. Interleukin-2 / administration & dosage. Male. Middle Aged. Treatment Outcome

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  • (PMID = 12777988.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Interleukin-2; 820484N8I3 / Histamine
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27. Avril MF, Aamdal S, Grob JJ, Hauschild A, Mohr P, Bonerandi JJ, Weichenthal M, Neuber K, Bieber T, Gilde K, Guillem Porta V, Fra J, Bonneterre J, Saïag P, Kamanabrou D, Pehamberger H, Sufliarsky J, Gonzalez Larriba JL, Scherrer A, Menu Y: Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study. J Clin Oncol; 2004 Mar 15;22(6):1118-25
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study.
  • PURPOSE: To compare fotemustine and dacarbazine (DTIC) in terms of overall response rate (ORR) as primary end-point and overall survival, duration of responses, time to progression, time to occurrence of brain metastases (BM), and to assess safety and quality of life in patients with disseminated cutaneous melanoma.
  • PATIENTS AND METHODS: Patients received either intravenous fotemustine 100 mg/m2 weekly for 3 weeks or DTIC 250 mg/m2/d for 5 consecutive days every 4 weeks (two cycles).
  • Nonprogressive patients received a maintenance treatment every 4 weeks (fotemustine 100 mg/m2 or DTIC 250 mg/m2 for 5 days).
  • RESULTS: Two hundred twenty-nine patients were randomly assigned to fotemustine or DTIC arms.
  • The best ORR was higher in the fotemustine arm than in the DTIC arm in the intent-to-treat population (n=229; 15.2% v 6.8%; P=.043) and in full analysis set (n=221) (15.5% v 7.2%; P=.053).
  • Similar median durations of responses (5.8 months with fotemustine v 6.9 months with DTIC) and time to progression (1.8 v 1.9 months, respectively) were observed.
  • In patients without BM at inclusion, the median time to BM was 22.7 months with fotemustine versus 7.2 months with DTIC (P=.059).
  • No significant difference was noted for quality of life between arms.
  • CONCLUSION: ORR was higher in the fotemustine arm compared to the DTIC arm in first-line treatment of disseminated melanoma.
  • A trend in favor of fotemustine in terms of overall survival and time to BM was evidenced.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Dacarbazine / therapeutic use. Melanoma / drug therapy. Nitrosourea Compounds / therapeutic use. Organophosphorus Compounds / therapeutic use. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Brain Neoplasms / epidemiology. Brain Neoplasms / secondary. Disease-Free Survival. Europe. Female. Humans. Male. Middle Aged. Quality of Life. Statistics, Nonparametric. Survival Analysis

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  • (PMID = 15020614.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Nitrosourea Compounds; 0 / Organophosphorus Compounds; 7GR28W0FJI / Dacarbazine; GQ7JL9P5I2 / fotemustine
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28. Hancock BW, Wheatley K, Harris S, Ives N, Harrison G, Horsman JM, Middleton MR, Thatcher N, Lorigan PC, Marsden JR, Burrows L, Gore M: Adjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma. J Clin Oncol; 2004 Jan 1;22(1):53-61
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Adjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma.
  • PURPOSE: To evaluate low-dose extended duration interferon alfa-2a as adjuvant therapy in patients with thick (> or = 4 mm) primary cutaneous melanoma and/or locoregional metastases.
  • PATIENTS AND METHODS: In this randomized controlled trial involving 674 patients, the effect of interferon alfa-2a (3 megaunits three times per week for 2 years or until recurrence) on overall survival (OS) and recurrence-free survival (RFS) was compared with that of no further treatment in radically resected stage IIB and stage III cutaneous malignant melanoma.
  • RESULTS: The OS and RFS rates at 5 years were 44% (SE, 2.6) and 32% (SE, 2.1), respectively.
  • There was no significant difference in OS or RFS between the interferon-treated and control arms (odds ratio [OR], 0.94; 95% CI, 0.75 to 1.18; P =.6; and OR, 0.91; 95% CI, 0.75 to 1.10; P =.3; respectively).
  • Male sex (P =.003) and regional lymph node involvement (P =.0009), but not age (P =.7), were statistically significant adverse features for OS.
  • Subgroup analysis by disease stage, age, and sex did not show any clear differences between interferon-treated and control groups in either OS or RFS.
  • However, there were 50 withdrawals (15%) from interferon treatment due to toxicity.
  • CONCLUSION: The results from this study, taken in isolation, do not indicate that extended-duration low-dose interferon is significantly better than observation alone in the initial treatment of completely resected high-risk malignant melanoma.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Antineoplastic Agents / therapeutic use. Interferon-alpha / administration & dosage. Interferon-alpha / therapeutic use. Melanoma / drug therapy. Melanoma / surgery. Skin Neoplasms / drug therapy. Skin Neoplasms / surgery
  • [MeSH-minor] Adolescent. Adult. Affect / drug effects. Age Factors. Aged. Aged, 80 and over. Disease-Free Survival. Dose-Response Relationship, Drug. Drug Administration Schedule. Fatigue / chemically induced. Female. Humans. Male. Middle Aged. Risk Factors. Treatment Outcome

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  • [CommentIn] J Clin Oncol. 2004 Jan 1;22(1):7-10 [14665612.001]
  • [CommentIn] J Clin Oncol. 2004 Jan 1;22(1):11-4 [14665613.001]
  • (PMID = 14665609.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha
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29. Schadendorf D, Hauschild A, Ugurel S, Thoelke A, Egberts F, Kreissig M, Linse R, Trefzer U, Vogt T, Tilgen W, Mohr P, Garbe C: Dose-intensified bi-weekly temozolomide in patients with asymptomatic brain metastases from malignant melanoma: a phase II DeCOG/ADO study. Ann Oncol; 2006 Oct;17(10):1592-7
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  • [Title] Dose-intensified bi-weekly temozolomide in patients with asymptomatic brain metastases from malignant melanoma: a phase II DeCOG/ADO study.
  • BACKGROUND: Temozolomide has shown some efficacy in metastatic melanoma and recently received extended approval to treat brain tumours.
  • The purpose of this study was to test a dose-intensified regimen of temozolomide in melanoma patients with brain metastases in a prospective, open-label, multicentre phase II trial.
  • PATIENTS AND METHODS: Forty-five patients with asymptomatic brain metastases from melanoma were stratified into arm A (no prior chemotherapy; n = 21) and arm B (previous chemotherapy; n = 24).
  • Patients received oral temozolomide either 150 mg/m(2)/day (arm A) or 125 mg/m(2)/day (arm B), days 1-7 and 15-21, every 28 days.
  • The primary study end point was objective response, and secondary end points were overall survival and safety.
  • RESULTS: Two patients (4.4%) achieved a partial response (PR) in brain metastases (one in each arm), one of them (2.2%) also showing a PR in extracerebral disease.
  • An additional five patients (11.1%; two in arm A, three in arm B) showed disease stabilisation (SD) in brain and other sites.
  • However, 82% revealed progressive disease (PD) already evident 8 weeks after therapy initiation.
  • Median survival time from therapy onset was 3.5 months (range 0.7-8.3; arm B) and 4.3 months (range 1.6-11.8; arm A), P = 0.43.
  • Dose modifications and prolongations of therapy cycles due to toxicity were required in 20% of patients.
  • CONCLUSIONS: Oral administration of temozolomide given bi-weekly is well-tolerated in melanoma patients with cerebral involvement.
  • However, the efficacy is limited, with lower than 5% objective responses observed in brain and extracerebral metastases.

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  • (PMID = 17005632.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; 7GR28W0FJI / Dacarbazine; 85622-93-1 / temozolomide
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30. Varker KA, Biber JE, Kefauver C, Jensen R, Lehman A, Young D, Wu H, Lesinski GB, Kendra K, Chen HX, Walker MJ, Carson WE 3rd: A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma. Ann Surg Oncol; 2007 Aug;14(8):2367-76
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  • [Title] A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma.
  • BACKGROUND: Vascular endothelial growth factor (VEGF) is a proangiogenic molecule produced by melanoma cells.
  • We hypothesized that administration of bevacizumab (Bev), a monoclonal antibody that neutralizes VEGF, with low-dose interferon alfa-2b (IFN-alpha2b), an inhibitor of basic fibroblast growth factor (FGF), would lead to the regression of metastatic melanoma.
  • METHODS: Patients with metastatic melanoma were randomized to receive Bev (15 mg/kg intravenously every 2 weeks) with or without low-dose IFN-alpha2b (1 MU/m2 subcutaneously daily).
  • Patients exhibiting a clinical response or stable disease after 12 weeks were treated until disease progression.
  • RESULTS: Thirty-two patients (16 per arm) were accrued (18 male, 14 female; mean age 57.5 years).
  • Six patients developed easily managed exacerbations of preexisting hypertension.
  • Two patients developed grade 3 proteinuria that resolved after a treatment break.
  • IFN-alpha2b therapy was associated with grade 1 to 2 constitutional symptoms.
  • Arterial thromboembolic complications were observed in three patients (two mild myocardial infarctions, one transient ischemic attack), all of whom had risk factors.
  • One patient (Bev plus IFN-alpha2b arm) had locally recurrent scalp disease that partially responded to therapy.
  • Eight patients (five Bev, three Bev plus IFN-alpha2b) had prolonged disease stabilization (24 to 146 weeks).
  • The patient with the longest period of stable disease had the highest baseline VEGF and FGF.
  • CONCLUSIONS: Bev was well tolerated at this dose and prolonged disease stabilization was achieved in one-quarter of metastatic melanoma patients.
  • [MeSH-major] Angiogenesis Inhibitors / administration & dosage. Antibodies, Monoclonal / administration & dosage. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal, Humanized. Bevacizumab. Chemotherapy, Adjuvant. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Humans. Immunologic Factors / administration & dosage. Immunologic Factors / adverse effects. Interferon-alpha / administration & dosage. Interferon-alpha / adverse effects. Male. Middle Aged. Neoplasm Metastasis. Recombinant Proteins

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  • (PMID = 17534686.001).
  • [ISSN] 1068-9265
  • [Journal-full-title] Annals of surgical oncology
  • [ISO-abbreviation] Ann. Surg. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA95426; United States / NCI NIH HHS / CA / K24 CA93670; United States / NCI NIH HHS / CA / P01 CA95426; United States / NCI NIH HHS / CA / P30 CA16058-28; United States / NCI NIH HHS / CA / T32 CA09338-27; United States / NCI NIH HHS / CA / U01 CA-076576-06
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Angiogenesis Inhibitors; 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0 / Immunologic Factors; 0 / Interferon-alpha; 0 / Recombinant Proteins; 2S9ZZM9Q9V / Bevacizumab; 99210-65-8 / interferon alfa-2b
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31. Danson S, Lorigan P, Arance A, Clamp A, Ranson M, Hodgetts J, Lomax L, Ashcroft L, Thatcher N, Middleton MR: Randomized phase II study of temozolomide given every 8 hours or daily with either interferon alfa-2b or thalidomide in metastatic malignant melanoma. J Clin Oncol; 2003 Jul 1;21(13):2551-7
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  • [Title] Randomized phase II study of temozolomide given every 8 hours or daily with either interferon alfa-2b or thalidomide in metastatic malignant melanoma.
  • PURPOSE: Temozolomide is an imidazotetrazine with a mechanism of action similar to dacarbazine and equivalent activity in melanoma.
  • It is well tolerated and is a candidate for combination chemotherapy and schedule manipulation.
  • The objectives of this randomized phase II, two-center study were to determine response rates, overall survival, and tolerability of the regimens in patients with advanced metastatic melanoma.
  • PATIENTS AND METHODS: One hundred eighty-one patients with metastatic melanoma were randomly assigned to receive up to six 4-weekly cycles consisting of temozolomide 200 mg/m2 every 8 hours for five doses, or temozolomide 200 mg/m2 daily for days 1 to 5 plus interferon alfa-2b 5 MU (million International Units) subcutaneously three times a week, or temozolomide 150 mg/m2 (increased after one cycle to 200 mg/m2) daily on days 1 to 5 plus thalidomide 100 mg daily days 1 to 28.
  • RESULTS: The treatment arms were well balanced for known prognostic factors.
  • Median survival was 5.3 months for 8-hourly temozolomide, 7.7 months for temozolomide/interferon, and 7.3 months for temozolomide/thalidomide; and 1-year survivals were 18%, 26%, and 24%, respectively.
  • Response or disease stabilization occurred in 20% of patients (95% confidence interval [CI], 10% to 33%) given 8-hourly temozolomide, 21% (95% CI, 12% to 33%) given temozolomide/interferon, and 25% (95% CI, 15% to 38%) given temozolomide/thalidomide.
  • Grade 3 or 4 nonhematologic toxicities were similar in each arm except for infection, which was more frequent with 8-hourly temozolomide.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Dacarbazine / analogs & derivatives. Melanoma / drug therapy. Neoplasm Metastasis. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Disease Progression. Drug Administration Schedule. Female. Humans. Infusions, Intravenous. Injections, Subcutaneous. Interferon-alpha / administration & dosage. Male. Middle Aged. Recombinant Proteins. Survival. Thalidomide / administration & dosage

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  • [CommentIn] Curr Oncol Rep. 2004 Sep;6(5):400 [15291984.001]
  • (PMID = 12829675.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Recombinant Proteins; 4Z8R6ORS6L / Thalidomide; 7GR28W0FJI / Dacarbazine; 85622-93-1 / temozolomide; 99210-65-8 / interferon alfa-2b
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32. Ockenfels M, Lisch W: [Ocular complications of adjuvant interferon therapy for malignant melanoma: a review]. Hautarzt; 2003 Feb;54(2):144-7
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  • [Title] [Ocular complications of adjuvant interferon therapy for malignant melanoma: a review].
  • [Transliterated title] Ubersicht zu Interferon-Nebenwirkungen am Auge bei adjuvanter Melanomtherapie.
  • BACKGROUND AND OBJECTIVE: In dermatology, interferon Alfa 2 is used in adjuvant therapy of melanoma (stage IIa/b) as well as in treatment of cutaneous lymphoma or melanoma (stage III or higher).
  • We wondered if incidence and prognosis of ocular complications were elevated in patients receiving an adjuvant treatment of melanoma with interferons.
  • More than the half of these patients developed significant visual loss including retinal ischemia.
  • CONCLUSIONS: These data underscore the importance to inform patients concerning ocular adverse effects and emphasize the need to monitor the retina during adjuvant interferon therapy.
  • [MeSH-major] Antineoplastic Agents / adverse effects. Eye Diseases / chemically induced. Interferon-alpha / adverse effects. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Chemotherapy, Adjuvant. Humans. Recombinant Proteins. Retinal Diseases / chemically induced. Retinal Diseases / diagnosis. Vision Disorders / chemically induced. Vision Disorders / diagnosis

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  • (PMID = 12590309.001).
  • [ISSN] 0017-8470
  • [Journal-full-title] Der Hautarzt; Zeitschrift für Dermatologie, Venerologie, und verwandte Gebiete
  • [ISO-abbreviation] Hautarzt
  • [Language] ger
  • [Publication-type] English Abstract; Journal Article; Review
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 76543-88-9 / interferon alfa-2a; 99210-65-8 / interferon alfa-2b
  • [Number-of-references] 15
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33. Tozer RG, Burdette-Radoux S, Berlanger K, Davis ML, Lohmann RC, Rusthoven JR, Wainman N, Zee B, Seymour L, National Cancer Institute of Canada Clinical Trials Group: A randomized phase II study of two schedules of bryostatin-1 (NSC339555) in patients with advanced malignant melanoma: A National Cancer Institute of Canada Clinical Trials Group study. Invest New Drugs; 2002 Nov;20(4):407-12
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  • [Title] A randomized phase II study of two schedules of bryostatin-1 (NSC339555) in patients with advanced malignant melanoma: A National Cancer Institute of Canada Clinical Trials Group study.
  • PURPOSE: This study addressed the efficacy and toxicity of the novel compound Bryostatin-1 (NSC 339555), a novel agent with antineoplastic, hematopoietic and immunomodulatory activity in a variety of in vitro and in vivo systems.
  • PATIENTS AND METHODS: This phase II study randomly assigned chemotherapy-naïve patients with untreated metastatic melanoma and measurable disease to two schedules of treatment: Arm A, 25 microg/m2 bryostatin-1 given as a 24 hour continuous infusion weekly or Arm B, 120 microg/m2 bryostatin-1 given as a 72 hour continuous infusion every 2 weeks.
  • Although objective response was assessed using standard NCIC CTG criteria, antitumour activity was assessed using a multivariate endpoint incorporating both response (CR and PR) and early progression (PD at < or = 8 weeks).
  • Seventeen patients were randomized to each arm.
  • RESULTS: Arm A was better tolerated with 86.7% of 15 evaluable patients receiving > or = 90% of planned dose intensity versus 76.5% of 17 evaluable patients in Arm B.
  • On Arm B, three patients experienced serious adverse events and three patients had to be removed from protocol therapy due to toxicity.
  • The most common side effect was myalgia (33% grade 1-2 on Arm A versus 65% on Arm B with 5 patients experiencing grade 3 and one patient grade 4).
  • Lethargy was more common on Arm A but more severe on Arm B.
  • Other side effects such as nausea, diarrhea and headache were generally mild to moderate in nature and occurred with a similar frequency on both arms.
  • This trial was closed early because the protocol-stopping rule was met based on lack of required responses and on the number of early progressions on both arms.
  • No partial or complete responses were seen; 3 patients randomized to Arm A had stable disease (duration 9-24 weeks) as did 4 patients (duration 10-38 weeks) randomized to Arm B.
  • CONCLUSION: Arm A was better tolerated than Arm B.
  • We conclude that bryostatin-1 has little efficacy in the treatment of metastatic melanoma with either of the schedules studied.
  • [MeSH-major] Lactones / therapeutic use. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Antineoplastic Protocols. Bryostatins. Drug Administration Schedule. Female. Humans. Infusions, Intravenous. Macrolides. Male. Middle Aged. Patients / statistics & numerical data

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  • (PMID = 12448658.001).
  • [ISSN] 0167-6997
  • [Journal-full-title] Investigational new drugs
  • [ISO-abbreviation] Invest New Drugs
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Bryostatins; 0 / Lactones; 0 / Macrolides; 37O2X55Y9E / bryostatin 1
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34. Handa U, Chhabra S, Mohan H: Aspiration cytology of extramammary tumours metastatic to the breast. Indian J Pathol Microbiol; 2007 Oct;50(4):855-8
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  • The metastatic tumors included, 2 cases of malignant melanoma (chest wall and left arm), 1 case each of haematolymphoid malignancy, adenocarcinoma of the ovary, and squamous cell carcinoma (left leg).
  • FNA diagnosis of metastasis to the breast is essential in order to avoid unnecessary mastectomy and to ensure appropriate chemotherapy and/or irradiation treatment.
  • [MeSH-major] Breast / pathology. Breast Neoplasms / diagnosis. Breast Neoplasms / pathology. Neoplasm Metastasis / diagnosis. Neoplasm Metastasis / pathology
  • [MeSH-minor] Adolescent. Adult. Biopsy, Fine-Needle. Diagnosis, Differential. Female. Humans

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  • (PMID = 18306588.001).
  • [ISSN] 0377-4929
  • [Journal-full-title] Indian journal of pathology & microbiology
  • [ISO-abbreviation] Indian J Pathol Microbiol
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] India
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35. Jelić S, Babovic N, Kovcin V, Milicevic N, Milanovic N, Popov I, Radosavljevic D: Comparison of the efficacy of two different dosage dacarbazine-based regimens and two regimens without dacarbazine in metastatic melanoma: a single-centre randomized four-arm study. Melanoma Res; 2002 Feb;12(1):91-8
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  • [Title] Comparison of the efficacy of two different dosage dacarbazine-based regimens and two regimens without dacarbazine in metastatic melanoma: a single-centre randomized four-arm study.
  • The aim of this randomized four-arm phase III study was to evaluate whether there is a difference in activity between regimens containing dacarbazine and regimens without dacarbazine in metastatic melanoma, whether there is a dose-effect relationship for dacarbazine, and whether non-dacarbazine-containing aggressive regimens are in any way superior to non-aggressive ones.
  • A total of 219 patients with metastatic cutaneous melanoma were included in this study; 196 of them were evaluable for activity.
  • The patients were randomized into four treatment arms: arm A (standard dose dacarbazine arm), vincristine 1.4 mg/m2 on day 1, carmustine (BCNU) 60 mg/m2 on day 1, and dacarbazine 300 mg/m2 per 24 h on days 2-5; arm B (high-dose dacarbazine arm), vincristine and BCNU as in arm A and dacarbazine 600 mg/m2 per 24 h on days 2-5; arm C ('aggressive' regimen without dacarbazine), vindesine 3 mg/m2 on day 1, bleomycin 7 mg/m2 per 24 h on days 1-4, and cisplatin 30 mg/m2 per 24 h on days 5-8; arm D ('non-aggressive' regimen without dacarbazine), BCNU 100 mg/m2 on day 1 and procarbazine 90 mg/m2 per 24 h on days 1-10.
  • The four arms were well balanced with regard to patient- and disease-related characteristics.
  • On an intend-to-treat basis, the response rate was 11 out of 49 (22%) in arm A, nine out of 47 (19%) in arm B, 16 out of 63 (25%) in arm C and nine out of 60 (15%) in arm D.
  • There was a large overlap between the 95% confidence intervals and no significant differences in the response rates between the four arms.
  • Median survival in the four treatment arms was 4, 5, 6 and 4 months, respectively, again with no significant differences.
  • Median survival for responders (8, 11, 10 and 13 months, respectively) in all four arms was significantly longer than in non-responders (4, 3, 5 and 4 months, respectively).
  • Arms A, B and C were significantly more toxic compared with arm D, which was for all practical purposes devoid of toxicities.
  • The efficacy of all four regimens thus appeared comparable both in terms of response rate and survival.
  • Responders in all four arms achieved a survival benefit.
  • There does not seem to be a dose-effect relationship for dacarbazine in metastatic melanoma.
  • Chemotherapy from arm D, might be well suited for 'fragile' or elderly patients due to the lack of toxicity.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Dacarbazine / administration & dosage. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Carmustine / administration & dosage. Dose-Response Relationship, Drug. Female. Humans. Male. Middle Aged. Procarbazine / administration & dosage. Time Factors. Treatment Outcome. Vincristine / administration & dosage

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  • (PMID = 11828263.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 35S93Y190K / Procarbazine; 5J49Q6B70F / Vincristine; 7GR28W0FJI / Dacarbazine; U68WG3173Y / Carmustine
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36. Sunderkötter C, Eickelmann M, Köhler M, Schmittel A, Wacker FK: Remission of extensive intrahepatic metastasis by C-arm computed tomography guided chemoembolization in uveal melanoma. J Dtsch Dermatol Ges; 2010 Jul;8(7):525-8
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  • [Title] Remission of extensive intrahepatic metastasis by C-arm computed tomography guided chemoembolization in uveal melanoma.
  • As soon as uveal melanoma has metastasized to the liver, response rates to systemic chemotherapy are low.
  • A 24-year-old woman suffered from inoperable hepatic metastases which grew to life-endangering size despite both systemic chemotherapy with gemcitabine/treosulfan and conventional intrahepatic chemoembolization with fotemustine and starch particles.
  • We subsequently performed two angiographic C-arm CT-guided, superselective chemoembolizations of the hepatic arteries feeding the tumor, using cisplatin, starch microspheres and ethiodized oil.
  • Following this treatment, no vital tumor tissue was detectable by MRI.
  • And the patient died 20 months after first detection of metastases.
  • However, the selective angiographic C-arm CT-guided chemoembolization resulted in prolongation of life with good quality despite the advanced stage of the disease.
  • [MeSH-major] Chemoembolization, Therapeutic / methods. Liver Neoplasms / secondary. Liver Neoplasms / therapy. Melanoma / secondary. Melanoma / therapy. Radiography, Interventional / methods. Uveal Neoplasms / therapy
  • [MeSH-minor] Adult. Female. Humans. Remission Induction. Tomography, X-Ray Computed / methods. Treatment Outcome

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  • (PMID = 19922465.001).
  • [ISSN] 1610-0387
  • [Journal-full-title] Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG
  • [ISO-abbreviation] J Dtsch Dermatol Ges
  • [Language] eng; ger
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Germany
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37. O'Day SJ, Maio M, Chiarion-Sileni V, Gajewski TF, Pehamberger H, Bondarenko IN, Queirolo P, Lundgren L, Mikhailov S, Roman L, Verschraegen C, Humphrey R, Ibrahim R, de Pril V, Hoos A, Wolchok JD: Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol; 2010 Aug;21(8):1712-7
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  • [Title] Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study.
  • BACKGROUND: This phase II study evaluated the safety and activity of ipilimumab, a fully human mAb that blocks cytotoxic T-lymphocyte antigen-4, in patients with advanced melanoma.
  • PATIENTS AND METHODS: Patients with previously treated, unresectable stage III/stage IV melanoma received 10 mg/kg ipilimumab every 3 weeks for four cycles (induction) followed by maintenance therapy every 3 months.
  • The primary end point was best overall response rate (BORR) using modified World Health Organization (WHO) criteria.
  • We also carried out an exploratory analysis of proposed immune-related response criteria (irRC).
  • RESULTS: BORR was 5.8% with a disease control rate (DCR) of 27% (N = 155).
  • One- and 2-year survival rates (95% confidence interval) were 47.2% (39.5% to 55.1%) and 32.8% (25.4% to 40.5%), respectively, with a median overall survival of 10.2 months (7.6-16.3).
  • Of 43 patients with disease progression by modified WHO criteria, 12 had disease control by irRC (8% of all treated patients), resulting in a total DCR of 35%.
  • Adverse events (AEs) were largely immune related, occurring mainly in the skin and gastrointestinal tract, with 19% grade 3 and 3.2% grade 4.
  • CONCLUSION: Ipilimumab demonstrated clinical activity with encouraging long-term survival in a previously treated advanced melanoma population.

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  • (PMID = 20147741.001).
  • [ISSN] 1569-8041
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / ipilimumab
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38. O'Neill PA, Butt M, Eswar CV, Gillis P, Marshall E: A prospective single arm phase II study of dacarbazine and treosulfan as first-line therapy in metastatic uveal melanoma. Melanoma Res; 2006 Jun;16(3):245-8
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  • [Title] A prospective single arm phase II study of dacarbazine and treosulfan as first-line therapy in metastatic uveal melanoma.
  • Uveal melanoma is relatively uncommon accounting for fewer than 5% of all melanoma cases.
  • Localized tumours are curable by local therapy but a significant percentage of patients go on to have a relapse with metastatic disease.
  • Uncertainty remains concerning the level of activity of dacarbazine in uveal melanoma as opposed to that in the cutaneous form.
  • Recently, a possible role for treosulfan in uveal disease has been reported.
  • A phase II study was therefore undertaken to assess the objective response rate of the combination of dacarbazine and treosulfan in previously untreated patients with metastatic uveal melanoma.
  • All patients received dacarbazine 850 mg/m and treosulfan 8 g/m(2) every 21 days up to a maximum of six cycles.
  • As expected, the major toxicities were haematological (particularly thrombocytopaenia) but the treatment was generally well tolerated.
  • No responses were seen; however, disease stabilization was achieved in two patients.
  • Median progression free survival from the start of chemotherapy was 12 weeks and median overall survival was 30 weeks.
  • This study, using the combination of dacarbazine and treosulfan, while well tolerated, did not confirm earlier reports suggesting treosulfan is active in uveal melanoma.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Uveal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Busulfan / administration & dosage. Busulfan / adverse effects. Busulfan / analogs & derivatives. Dacarbazine / administration & dosage. Dacarbazine / adverse effects. Female. Humans. Male. Middle Aged. Neoplasm Metastasis. Prospective Studies. Thrombocytopenia / chemically induced

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  • (PMID = 16718271.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 7GR28W0FJI / Dacarbazine; CO61ER3EPI / treosulfan; G1LN9045DK / Busulfan
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39. Paciucci PA, Ryder JS, Mandell JP, Morris JC, Holland JF: Interleukin-2 plus chemotherapy for patients with metastatic melanoma. Melanoma Res; 2000 Jun;10(3):291-5
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  • [Title] Interleukin-2 plus chemotherapy for patients with metastatic melanoma.
  • We studied the activity of recombinant interleukin-2 (IL2) in combination with multiagent chemotherapy in the treatment of patients with disseminated malignant melanoma.
  • Twenty-two patients, 18 males and four females with a median age of 44 years (range 32-73 years) were randomized to receive IL2 5 million units/m2 once daily by SB injection or by CI, 5 days/week for 2 weeks.
  • All patients received a chemotherapy regimen consisting of lomustine (CCNU) 75 mg/m2 on day 14, bleomycin 10 units/day by CI for 5 days (days 14-19) and cisplatin 75 mg/m2 on day 19.
  • There were four complete responses and one partial response in the CI arm and two partial responses in the SB arm.
  • The median duration of response was 38 weeks (range 26-107 weeks).
  • The median duration of survival was 6.7 months in non-responders and 11.1 months in responders.
  • The overall response rate was 32%.
  • Since responses were brief and all the responding patients progressed after a median of 38 weeks, the study was terminated before accrual goals were met.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Interleukin-2 / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Bleomycin / administration & dosage. Cisplatin / administration & dosage. Combined Modality Therapy. Female. Humans. Infusions, Intravenous. Injections, Subcutaneous. Lomustine / administration & dosage. Male. Middle Aged. Recombinant Proteins / administration & dosage. Recombinant Proteins / therapeutic use. Remission Induction. Survival Rate

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  • (PMID = 10890384.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / 5-P30-CA23102
  • [Publication-type] Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] ENGLAND
  • [Chemical-registry-number] 0 / Interleukin-2; 0 / Recombinant Proteins; 11056-06-7 / Bleomycin; 7BRF0Z81KG / Lomustine; Q20Q21Q62J / Cisplatin
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40. Yoshida Y, Takahashi A, Koga M, Koga K, Kubota Y, Nakayama J: Case of metastatic melanoma in an epitrochlear lymph node arising in a pregnant woman. J Dermatol; 2007 Jan;34(1):48-51
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  • [Title] Case of metastatic melanoma in an epitrochlear lymph node arising in a pregnant woman.
  • We describe a rare case of metastatic melanoma in an epitrochlear lymph node in a 29-year-old female patient.
  • The patient had been aware of a brown macule on her right posterior forearm at puberty.
  • Histological examination revealed a malignant melanoma.
  • She underwent wide local excision with 3-cm margins and split thickness skin graft closure, but we were not able to perform sentinel node biopsy.
  • She also received three cycles of systemic chemotherapy with dacarbazine, nimustine, vincristine and interferon-beta.
  • We emphasize that it is important for clinicians to pay attention to the possibility of epitrochlear node metastasis in patients with malignant melanoma in the upper extremity and that it is necessary to perform sentinel node biopsy to identify uncommon lymph node metastasis.
  • [MeSH-major] Melanoma / secondary. Pregnancy Complications, Neoplastic. Skin Neoplasms / pathology
  • [MeSH-minor] Adult. Arm. Female. Humans. Lymph Node Excision. Lymphatic Metastasis. Pregnancy

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  • (PMID = 17204101.001).
  • [ISSN] 0385-2407
  • [Journal-full-title] The Journal of dermatology
  • [ISO-abbreviation] J. Dermatol.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Japan
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41. Boasberg P, Hamid O, O'Day S: Ipilimumab: unleashing the power of the immune system through CTLA-4 blockade. Semin Oncol; 2010 Oct;37(5):440-9
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  • [Title] Ipilimumab: unleashing the power of the immune system through CTLA-4 blockade.
  • Malignant melanoma is rising faster in incidence than any other malignancy.
  • Long-term remission or "cure" is rare and is almost exclusively limited to therapies that stimulate an immune antitumor response.
  • Ipilimumab is a novel targeted human immunostimulatory monoclonal antibody that blocks cytotoxic T-lymphocyte antigen4 (CTLA-4), an immune-inhibitory site expressed on activated T cells.
  • Ipilimumab is well tolerated as an outpatient infusion therapy.
  • A randomized trial has documented a survival benefit when ipilimumab was compared to a gp-100 vaccine only arm.
  • The unique mechanism of action of ipilimumab makes assessment of response by conventional criteria difficult.
  • Benefit from ipilimumab can occur after what would be considered progression with World Health Oganization (WHO) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • New immune response criteria have been proposed.
  • Therapeutic responses peak between 12 and 24 weeks, with slow responses continuing up to and beyond 12 months.
  • The major drug- related adverse side effects (10%-15% grade 3 or above) are immune-related and consist most commonly of rash, colitis, hypophysitis, thyroiditis, and hepatitis.
  • Colonic perforation can occur and patients with diarrhea have to be monitored carefully with strict adherence to treatment algorithms.
  • Algorithms for the treatment of other adverse side effects have been developed.
  • The treatment of immune-related side effects with immunosuppressive agents, such as corticosteroids, does not appear to impair antitumor response.
  • With proper monitoring and management of side effects, ipilimumab is an extremely safe drug to administer.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antigens, CD / immunology. Antineoplastic Agents / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. CTLA-4 Antigen. Dacarbazine / administration & dosage. Drug-Related Side Effects and Adverse Reactions. Humans

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  • [Copyright] Copyright © 2010. Published by Elsevier Inc.
  • (PMID = 21074058.001).
  • [ISSN] 1532-8708
  • [Journal-full-title] Seminars in oncology
  • [ISO-abbreviation] Semin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antigens, CD; 0 / Antineoplastic Agents; 0 / CTLA-4 Antigen; 0 / CTLA4 protein, human; 0 / ipilimumab; 7GR28W0FJI / Dacarbazine
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42. O'Connor R, O'Leary M, Ballot J, Collins CD, Kinsella P, Mager DE, Arnold RD, O'Driscoll L, Larkin A, Kennedy S, Fennelly D, Clynes M, Crown J: A phase I clinical and pharmacokinetic study of the multi-drug resistance protein-1 (MRP-1) inhibitor sulindac, in combination with epirubicin in patients with advanced cancer. Cancer Chemother Pharmacol; 2007 Jan;59(1):79-87
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  • [Title] A phase I clinical and pharmacokinetic study of the multi-drug resistance protein-1 (MRP-1) inhibitor sulindac, in combination with epirubicin in patients with advanced cancer.
  • PURPOSE: Multi-drug resistance mediated by ATP-binding cassette trans-membrane protein pumps is an important cause of cancer treatment failure.
  • Sulindac has been shown to be a competitive substrate for the clinically important resistance protein, multi-drug resistance protein-1 (MRP-1), and thus might enhance the anti-cancer activity of substrate chemotherapeutic agents, e.g. anthracyclines.
  • METHODS: We conducted a dose-escalating, single arm, prospective, open label, non-randomised phase I trial of epirubicin (75 mg/m(2)) in combination with escalating oral doses of sulindac (0-800 mg) in patients with advanced cancer to identify an appropriate dose of sulindac to use in future resistance studies.
  • Anthracycline and sulindac pharmacokinetics were studied in cycles 1 and 3.
  • RESULTS: Seventeen patients (8 breast, 3 lung, 2 bowel, 1 melanoma, 1 renal, 1 ovarian and 1 of unknown primary origin, 16/17 having had prior chemotherapy) were enrolled.
  • Eight patients received a full six cycles of treatment; 14 patients received three or more cycles.
  • Dose-limiting toxicity was observed in two patients at 800 mg sulindac (1 renal impairment, 1 fatal haemoptysis in a patient with advanced lung cancer), and sulindac 600 mg was deemed to be the maximum tolerated dose.
  • Among 15 patients with evaluable tumour, two partial responses were seen (malignant melanoma and breast cancer).
  • Four others had prolonged stable disease.
  • [MeSH-major] Anti-Inflammatory Agents, Non-Steroidal / pharmacokinetics. Anti-Inflammatory Agents, Non-Steroidal / therapeutic use. Antibiotics, Antineoplastic / therapeutic use. Epirubicin / therapeutic use. Neoplasms / drug therapy. P-Glycoprotein / antagonists & inhibitors. Sulindac / pharmacokinetics. Sulindac / therapeutic use
  • [MeSH-minor] Adult. Aged. Chemotherapy, Adjuvant. Creatinine / blood. Dose-Response Relationship, Drug. Drug Resistance, Multiple / drug effects. Drug Resistance, Neoplasm / drug effects. Female. Humans. Immunohistochemistry. Male. Middle Aged. Myocardium / metabolism. Platelet Count. Prospective Studies. Troponin / metabolism

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  • (PMID = 16642371.001).
  • [ISSN] 0344-5704
  • [Journal-full-title] Cancer chemotherapy and pharmacology
  • [ISO-abbreviation] Cancer Chemother. Pharmacol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Anti-Inflammatory Agents, Non-Steroidal; 0 / Antibiotics, Antineoplastic; 0 / P-Glycoprotein; 0 / Troponin; 184SNS8VUH / Sulindac; 3Z8479ZZ5X / Epirubicin; AYI8EX34EU / Creatinine
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43. Lee CH, Moon KY, Chung CK, Kim HJ, Chang KH, Park SH, Jahng TA: Primary intradural extramedullary melanoma of the cervical spinal cord: case report. Spine (Phila Pa 1976); 2010 Apr 15;35(8):E303-7
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  • [Title] Primary intradural extramedullary melanoma of the cervical spinal cord: case report.
  • OBJECTIVE: We report a case of primary intradural extramedullary melanoma of the cervical spinal cord in a nonwhite patient.
  • SUMMARY OF BACKGROUND DATA: Melanoma occurs most commonly in white populations and is rare in Asian populations.
  • Primary malignant melanoma of the spinal cord is a rare disease entity that predominately affects the middle or lower thoracic spine.
  • METHODS: A 39-year-old man presented with a tingling sensation in the upper extremities accompanied by motor weakness of the lower extremities.
  • Preoperative magnetic resonance imaging (MRI) of the cervical spine suggested a multiloculated subdural hematoma in the subacute stage that spread from the level of C1 to the level of C6.
  • RESULTS: A standard posterior midline approach was used under the impression that the subacute subdural hematoma was caused by a hidden vascular anomaly or a rare, intradural, pigmented tumor.
  • Histopathological investigation confirmed malignant melanoma.
  • No hypermetabolic lesions were noted on whole-body FDG-PET.
  • Additional dermatologic and ophthalmologic examinations did not reveal any other foci of primary melanoma.
  • Subsequent radiotherapy and chemotherapy were administered.
  • CONCLUSION: Unlike most cases of primary intradural melanoma, this patient presented with unusual radiologic findings in the cervical spinal cord.
  • The case described in the present study illustrates that primary spinal cord melanoma is rare and must be diagnosed with caution due to its variable clinical and radiologic presentation.
  • [MeSH-major] Melanoma / pathology. Melanoma / therapy. Spinal Cord Compression / etiology. Spinal Cord Neoplasms / pathology. Spinal Cord Neoplasms / therapy
  • [MeSH-minor] Activities of Daily Living. Adult. Asian Continental Ancestry Group. Biomarkers, Tumor. Combined Modality Therapy. Decompression, Surgical. Diagnosis, Differential. Drug Therapy. Humans. Laminectomy. Magnetic Resonance Imaging. Male. Muscle Weakness / etiology. Neurosurgical Procedures. Paresthesia / etiology. Positron-Emission Tomography. Radiotherapy. Spinal Cord / pathology. Spinal Cord / physiopathology. Spinal Cord / surgery. Treatment Outcome

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  • (PMID = 20308942.001).
  • [ISSN] 1528-1159
  • [Journal-full-title] Spine
  • [ISO-abbreviation] Spine
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Biomarkers, Tumor
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44. Oblimersen: Augmerosen, BCL-2 antisense oligonucleotide - Genta, G 3139, GC 3139, oblimersen sodium. Drugs R D; 2007;8(5):321-34
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  • Oblimersen is an antisense oligonucleotide developed by Genta for systemic use as an injection.
  • Oblimersen targets the first six codons of Bcl-2 mRNA to form a DNA/RNA complex.
  • By reducing the amount of Bcl-2 protein in cancer cells, oblimersen may enhance the effectiveness of conventional anticancer treatments.
  • Genta has reported results from randomised phase III trials of oblimersen in four different indications: malignant melanoma, chronic lymphocytic leukaemia (CLL), multiple myeloma and acute myleoid leukaemia (AML).
  • A negative opinion has been issued for the company's MAA for the product in the treatment of malignant melanoma in the EU; the EMEA has indicated an additional confirmatory trial is needed in this indication for approval.
  • An NDA for CLL was deemed non-approvable by the US FDA; the company is appealing this decision.
  • Phase I and II trials are also underway or have been completed for a range of other cancer types.
  • Genta became solely responsible for all costs relating to oblimersen at this time.
  • Genta expanded its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute in November 2001.
  • The expanded collaboration was to investigate the use of oblimersen in combination with standard anticancer therapy in a broad range of cancers.
  • This expansion occurred following the Gensynergy project, which showed that oblimersen was synergistic with other anticancer therapies.
  • The application was based on data from a phase I/II trial (NCT00021749) of oblimersen alone in approximately 40 patients and a phase III study (NCT00024440) of 241 patients who received fludarabine and cyclo-phosphamide with or without oblimersen.
  • Genta received a Special Protocol Assessment (SPA) from the FDA in October 2006 for a randomised, pivotal, clinical trial of oblimersen in CLL.
  • The trial will be conducted in patients who have not received prior chemotherapy and who would be randomised to receive fludarabine and rituximab with or without oblimersen.
  • Oblimersen previously obtained orphan drug status in the US and EU for CLL in September 2001.
  • Genta previously submitted the MAA under the centralised licensing procedure and Spain and France were assigned as rapporteur and co-rapporteur countries, respectively.
  • Genta intends to file a formal complaint and a request for correction of information with the FDA under the Federal Data Quality Act.
  • The complaint is related to a key statistical analysis of the company's data for oblimersen in the treatment of melanoma used by the FDA at the Oncology Drug Advisory Committee (ODAC) in May 2004.
  • Genta believes that analysis sought to discredit the finding that treatment with oblimersen significantly increased progression-free survival; ODAC previously agreed this endpoint would support full approval in the absence of a survival improvement in patients with advanced melanoma.A rolling NDA submission was submitted to the FDA in the third quarter of 2003; however, Genta and Aventis withdrew the NDA after the application failed to gain marketing approval from the FDA's Oncology Drug Advisory Committee (ODAC).
  • In May 2004, ODAC voted that phase III trial results did not provide substantial evidence of effectiveness to outweigh toxicity of oblimersen treatment in patients with metastatic melanoma.
  • The FDA gave oblimersen orphan drug status for malignant melanoma in August 2000.
  • In October 1999, fast-track status was given to oblimersen by the FDA for malignant melanoma when used in combination with dacarbazine.
  • In addition, oblimersen received orphan drug status for malignant melanoma in Australia in October 2006.A phase III study (NCT00016263) of oblimersen in combination with dacarbazine was conducted in patients with malignant melanoma.
  • The combination treatment did not significantly increase overall survival time, but did significantly increase progression-free survival time, compared with dacarbazine treatment alone.
  • The primary endpoint of this trial was to compare the overall survival between the two treatment arms.
  • Secondary endpoints included comparative analyses of progression-free survival and tumour response.
  • Genta will conduct another phase III study of oblimersen in patients with advanced melanoma.
  • The trial is designed to provide additional safety and efficacy evidence of the drug, in combination with dacarbazine, in patients who have not previously received chemotherapy.
  • Approximately 300 patients are expected to be enrolled in the trial, which is planned to begin during mid-2007, at sites throughout Europe, Australia, and North and South America.
  • Genta is conducting a phase I clinical trial (NCT00409383) to evaluate the combination of oblimersen, ABI 007, and temozolomide in chemotherapy-naive patients with advanced melanoma.
  • Oblimersen received orphan drug status in the US and EU for multiple myeloma in September 2001.
  • In addition, fast-track designation was given to oblimersen by the FDA in the same month.A phase I/II clinical study (NCT00062244) of oblimersen was conducted by the NCI in patients with Waldenstrom's macroglobulinaemia, a disease that is similar to multiple myeloma.
  • The study results indicated that oblimersen may be a useful treatment in this group of patients (all had high levels of Bcl-2 expression).
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Neoplasms / drug therapy. Oligonucleotides, Antisense / therapeutic use. Proto-Oncogene Proteins c-bcl-2 / genetics. Thionucleotides / therapeutic use

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  • (PMID = 17767397.001).
  • [ISSN] 1174-5886
  • [Journal-full-title] Drugs in R&D
  • [ISO-abbreviation] Drugs R D
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Oligonucleotides, Antisense; 0 / Proto-Oncogene Proteins c-bcl-2; 0 / Thionucleotides; 85J5ZP6YSL / oblimersen
  • [Number-of-references] 72
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45. Bilaç C, Müezzinoğlu T, Ermertcan AT, Kayhan TC, Temeltaş G, Oztürkcan S, Temiz P: Sorafenib-induced erythema multiforme in metastatic renal cell carcinoma. Cutan Ocul Toxicol; 2009;28(2):90-2
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  • [Title] Sorafenib-induced erythema multiforme in metastatic renal cell carcinoma.
  • Sorafenib is a new therapeutic agent being used in metastatic renal cell carcinoma, hepatocellular carcinoma, and malignant melanoma.
  • The most frequently seen cutaneous side effects due to sorafenib are erythema, exfoliative dermatitis, acne vulgaris, and flushing.
  • A 59-year-old man underwent left radical nephrectomy due to renal cell carcinoma 8 months ago, and after the operation he received immunochemotherapy and then sorafenib.
  • On the third day of sorafenib therapy his lesions occurred.
  • His dermatologic examination revealed multiple erythematous papules on his neck, arms, and legs and bullae and iris lesions on his palms and soles.
  • We present this interesting case to show and discuss cutaneous side effects of sorafenib, especially erythema multiforme as a very rare cutaneous side effect.
  • [MeSH-major] Antineoplastic Agents / adverse effects. Benzenesulfonates / adverse effects. Carcinoma, Renal Cell / drug therapy. Erythema Multiforme / chemically induced. Kidney Neoplasms / drug therapy. Pyridines / adverse effects
  • [MeSH-minor] Dose-Response Relationship, Drug. Humans. Male. Middle Aged. Niacinamide / analogs & derivatives. Phenylurea Compounds. Treatment Outcome

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  • (PMID = 19514932.001).
  • [ISSN] 1556-9535
  • [Journal-full-title] Cutaneous and ocular toxicology
  • [ISO-abbreviation] Cutan Ocul Toxicol
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Benzenesulfonates; 0 / Phenylurea Compounds; 0 / Pyridines; 25X51I8RD4 / Niacinamide; 9ZOQ3TZI87 / sorafenib
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46. Cornett WR, McCall LM, Petersen RP, Ross MI, Briele HA, Noyes RD, Sussman JJ, Kraybill WG, Kane JM 3rd, Alexander HR, Lee JE, Mansfield PF, Pingpank JF, Winchester DJ, White RL Jr, Chadaram V, Herndon JE 2nd, Fraker DL, Tyler DS, American College of Surgeons Oncology Group Trial Z0020: Randomized multicenter trial of hyperthermic isolated limb perfusion with melphalan alone compared with melphalan plus tumor necrosis factor: American College of Surgeons Oncology Group Trial Z0020. J Clin Oncol; 2006 Sep 1;24(25):4196-201
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  • [Title] Randomized multicenter trial of hyperthermic isolated limb perfusion with melphalan alone compared with melphalan plus tumor necrosis factor: American College of Surgeons Oncology Group Trial Z0020.
  • PURPOSE: To determine in a randomized prospective multi-institutional trial whether the addition of tumor necrosis factor alpha (TNF-alpha) to a melphalan-based hyperthermic isolated limb perfusion (HILP) treatment would improve the complete response rate for locally advanced extremity melanoma.
  • PATIENTS AND METHODS: Patients with locally advanced extremity melanoma were randomly assigned to receive melphalan or melphalan plus TNF-alpha during standard HILP.
  • Patient randomization was stratified according to disease/treatment status and regional nodal disease status.
  • Grade 4 adverse events were observed in 14 (12%) of 129 patients, with three (4%) of 64 in the melphalan-alone arm and 11 (16%) of 65 in the melphalan-plus-TNF-alpha arm (P = .0436).
  • There were two toxicity-related lower extremity amputations in the melphalan-plus-TNF-alpha arm, and one disease progression-related upper extremity amputation in the melphalan-alone arm.
  • There was no treatment-related mortality in either arm of the study.
  • Sixty-four percent of patients (36 of 58) in the melphalan-alone arm and 69% of patients (40 of 58) in the melphalan-plus-TNF-alpha arm showed a response to treatment at 3 months, with a complete response rate of 25% (14 of 58 patients) in the melphalan-alone arm and 26% (15 of 58 patients) in the melphalan-plus-TNF-alpha arm (P = .435 and P = .890, respectively).
  • CONCLUSION: In locally advanced extremity melanoma treated with HILP, the addition of TNF-alpha to melphalan did not demonstrate a significant enhancement of short-term response rates over melphalan alone by the 3-month follow-up, and TNF-alpha plus melphalan was associated with a higher complication rate.
  • [MeSH-major] Antineoplastic Agents, Alkylating / administration & dosage. Chemotherapy, Cancer, Regional Perfusion. Extremities. Hyperthermia, Induced. Melanoma / drug therapy. Melphalan / administration & dosage. Skin Neoplasms / drug therapy. Tumor Necrosis Factor-alpha / administration & dosage
  • [MeSH-minor] Adult. Aged. Female. Humans. Male. Middle Aged. Patient Selection. Treatment Outcome. United States

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  • [CommentIn] J Clin Oncol. 2007 Mar 20;25(9):1149; author reply 1149-51 [17369585.001]
  • [CommentIn] J Clin Oncol. 2007 Apr 10;25(11):1449-50; author reply 1450-1 [17416870.001]
  • (PMID = 16943537.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / U10 CA076001
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; 0 / Tumor Necrosis Factor-alpha; Q41OR9510P / Melphalan
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47. Bajetta E, Del Vecchio M, Nova P, Fusi A, Daponte A, Sertoli MR, Queirolo P, Taveggia P, Bernengo MG, Legha SS, Formisano B, Cascinelli N: Multicenter phase III randomized trial of polychemotherapy (CVD regimen) versus the same chemotherapy (CT) plus subcutaneous interleukin-2 and interferon-alpha2b in metastatic melanoma. Ann Oncol; 2006 Apr;17(4):571-7
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  • [Title] Multicenter phase III randomized trial of polychemotherapy (CVD regimen) versus the same chemotherapy (CT) plus subcutaneous interleukin-2 and interferon-alpha2b in metastatic melanoma.
  • BACKGROUND: The addition of cytokines to chemotherapy (CT) has obtained encouraging but contradictory results in metastatic melanoma.
  • PATIENTS AND METHODS: A total of 151 untreated metastatic melanoma patients were randomized, 75 on arm A (cisplatin 30 mg/m2 on days 1-3, vindesine 2.5 mg/m2 on day 1 and dacarbazine 250 mg/m2 on days 1-3), and 76 on arm B (same CVD scheme plus interferon-alpha2b on days 1-5 and interleukin-2 on days 1-5 and 8-15, both administered subcutaneously), either recycled every 3 weeks.
  • Response was assessed every two cycles.
  • RESULTS: Ten percent of the patients were alive at a median of 52 months from start of therapy.
  • We observed a response rate (RR) of 21% on arm A versus 33% on arm B; three patients (4%) given bioCT had complete responses (CRs).
  • Median time to progression (TTP) was identical; median overall survival (OS) time was 12 months on arm A and 11 months on arm B.
  • CONCLUSIONS: BioCT is not better than CT alone; the trend in favor of the bioCT in terms of RR did not translate into better TTP or OS.
  • Therefore, bioCT cannot be recommended as standard first-line therapy for metastatic melanoma.

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  • (PMID = 16469753.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Interleukin-2; 0 / Recombinant Proteins; 5V9KLZ54CY / Vinblastine; 7GR28W0FJI / Dacarbazine; 99210-65-8 / interferon alfa-2b; Q20Q21Q62J / Cisplatin
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48. Chiarion Sileni V, Nortilli R, Aversa SM, Paccagnella A, Medici M, Corti L, Favaretto AG, Cetto GL, Monfardini S: Phase II randomized study of dacarbazine, carmustine, cisplatin and tamoxifen versus dacarbazine alone in advanced melanoma patients. Melanoma Res; 2001 Apr;11(2):189-96
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  • [Title] Phase II randomized study of dacarbazine, carmustine, cisplatin and tamoxifen versus dacarbazine alone in advanced melanoma patients.
  • This randomized phase II trial was performed to define the activity and toxicity of the combination of dacarbazine (DTIC), carmustine (BCNU), cisplatin (DDP) and tamoxifen (DBDT regimen) versus DTIC alone in patients with metastatic melanoma.
  • Sixty patients with metastatic melanoma were randomly assigned to receive BCNU 150 mg/m2 intravenously (i.v.) on day 1, cisplatin 25 mg/m2 i.v. daily on days 1 to 3, DTIC 220 mg/m2 i.v. daily on days 1 to 3 and tamoxifen 160 mg orally daily for 7 days prior to chemotherapy (DBDT arm; arm A).
  • Treatment cycles were repeated every 28 days, while BCNU was given every two cycles.
  • The DTIC arm (arm B) patients received DTIC alone 1200 mg/m2 i.v. on day 1, repeated every 21 days.
  • Patients were evaluated every two cycles; responding patients continued the treatment for a maximum of 12 cycles.
  • The overall response rate was 26% in the DBDT arm and 5% in the DTIC arm.
  • Complete responses were 2.5% for DBDT and 0% for DTIC.
  • The median progression-free survival and the median survival were 4 and 9 months, respectively for DBDT, and 2 and 7 months for DTIC.
  • In conclusion, the overall response rate obtained with DBDT was greater than that obtained with DTIC alone; however, this combination increases toxicity with limited impact on overall survival.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carmustine / administration & dosage. Cisplatin / administration & dosage. Dacarbazine / administration & dosage. Dacarbazine / therapeutic use. Tamoxifen / administration & dosage
  • [MeSH-minor] Adult. Aged. Antineoplastic Agents / administration & dosage. Antineoplastic Agents, Alkylating / administration & dosage. Antineoplastic Agents, Alkylating / therapeutic use. Antineoplastic Agents, Hormonal / administration & dosage. Disease-Free Survival. Female. Follow-Up Studies. Humans. Male. Middle Aged. Time Factors. Treatment Outcome

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  • (PMID = 11333130.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Antineoplastic Agents, Alkylating; 0 / Antineoplastic Agents, Hormonal; 094ZI81Y45 / Tamoxifen; 7GR28W0FJI / Dacarbazine; Q20Q21Q62J / Cisplatin; U68WG3173Y / Carmustine
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49. Vuoristo MS, Hahka-Kemppinen M, Parvinen LM, Pyrhönen S, Seppä H, Korpela M, Kellokumpu-Lehtinen P: Randomized trial of dacarbazine versus bleomycin, vincristine, lomustine and dacarbazine (BOLD) chemotherapy combined with natural or recombinant interferon-alpha in patients with advanced melanoma. Melanoma Res; 2005 Aug;15(4):291-6
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  • [Title] Randomized trial of dacarbazine versus bleomycin, vincristine, lomustine and dacarbazine (BOLD) chemotherapy combined with natural or recombinant interferon-alpha in patients with advanced melanoma.
  • This randomized phase II study was designed to compare the efficacy and tolerability of dacarbazine (DTIC) and bleomycin, vincristine, lomustine and DTIC (BOLD) combined with natural interferon-alpha (nIFN-alpha) or recombinant interferon-alpha2b (rIFN-alpha2b) in patients with advanced melanoma.
  • The treatment arms were: A, DTIC plus nIFN-alpha; B, BOLD plus nIFN-alpha; C, DTIC plus rIFN-alpha2b; D, BOLD plus rIFN-alpha2b.
  • The response rates were 8% (2/25) in arm A, 13% (4/31) in arm B, 12% (3/25) in arm C and 24% (6/25) in arm D.
  • All of the eight complete responses occurred in patients with soft tissue and/or lung metastases and the BOLD regimens produced six of them.
  • There were no significant differences in survival (arm A, 11.1 months; arm B, 9.8 months; arm C, 9.1 months; arm D, 7.5 months; P=0.62).
  • With the present sample size, there were no statistically significant differences in efficacy between the arms, but there was a trend towards a higher response rate with BOLD plus rIFN-alpha2b.
  • Patients with soft tissue or lung metastases may achieve more complete responses with BOLD regimens.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Interferon Type I / therapeutic use. Interferon-alpha / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Bleomycin / administration & dosage. Bleomycin / therapeutic use. Dacarbazine / administration & dosage. Dacarbazine / therapeutic use. Female. Humans. Lomustine / administration & dosage. Lomustine / therapeutic use. Male. Middle Aged. Neoplasm Metastasis. Recombinant Proteins. Survival Analysis. Treatment Outcome. Vincristine / administration & dosage. Vincristine / therapeutic use

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  • (PMID = 16034308.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon Type I; 0 / Interferon-alpha; 0 / Recombinant Proteins; 11056-06-7 / Bleomycin; 5J49Q6B70F / Vincristine; 7BRF0Z81KG / Lomustine; 7GR28W0FJI / Dacarbazine; BOLD protocol
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50. Garbe C, Radny P, Linse R, Dummer R, Gutzmer R, Ulrich J, Stadler R, Weichenthal M, Eigentler T, Ellwanger U, Hauschild A: Adjuvant low-dose interferon {alpha}2a with or without dacarbazine compared with surgery alone: a prospective-randomized phase III DeCOG trial in melanoma patients with regional lymph node metastasis. Ann Oncol; 2008 Jun;19(6):1195-201
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  • [Title] Adjuvant low-dose interferon {alpha}2a with or without dacarbazine compared with surgery alone: a prospective-randomized phase III DeCOG trial in melanoma patients with regional lymph node metastasis.
  • BACKGROUND: More than half of patients with melanoma that has spread to regional lymph nodes develop recurrent disease within the first 3 years after surgery.
  • The aim of the study was to improve disease-free survival (DFS) and overall survival (OS) with interferon (IFN) alpha2a with or without dacarbazine (DTIC) compared with observation alone.
  • PATIENTS AND METHODS: A total of 444 patients from 42 centers of the German Dermatologic Cooperative Oncology Group who had received a complete lymph node dissection for pathologically proven regional node involvement were randomized to receive either 3 MU s.c. of IFNalpha2a three times a week for 2 years (Arm A) or combined treatment with same doses of IFNalpha2a plus DTIC 850 mg/m(2) every 4-8 weeks for 2 years (Arm B) or to observation alone (Arm C).
  • Treatment was discontinued at first sign of relapse.
  • Kaplan-Meier 4-year OS rate of those who had received IFNalpha2a was 59%.
  • No improvement of survival was found for the combined treatment Arm B with 45% survival rate (B versus C, P = 0.76).
  • Similarly, DFS rates showed significant benefit for Arm A, and not for Arm B.
  • Multivariate Cox model confirmed that Arm A has an impact on OS (P = 0.005) but not Arm B (P = 0.34).
  • CONCLUSIONS: 3 MU interferon alpha2a given s.c. three times a week for 2 years significantly improved OS and DFS in patients with melanoma that had spread to the regional lymph nodes.
  • Interestingly, the addition of DTIC reversed the beneficial effect of adjuvant interferon alpha2a therapy.

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  • (PMID = 18281266.001).
  • [ISSN] 1569-8041
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 76543-88-9 / interferon alfa-2a; 7GR28W0FJI / Dacarbazine
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51. Kirkwood JM, Richards T, Zarour HM, Sosman J, Ernstoff M, Whiteside TL, Ibrahim J, Blum R, Wieand S, Mascari R: Immunomodulatory effects of high-dose and low-dose interferon alpha2b in patients with high-risk resected melanoma: the E2690 laboratory corollary of intergroup adjuvant trial E1690. Cancer; 2002 Sep 1;95(5):1101-12
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  • [Title] Immunomodulatory effects of high-dose and low-dose interferon alpha2b in patients with high-risk resected melanoma: the E2690 laboratory corollary of intergroup adjuvant trial E1690.
  • BACKGROUND: The clinical antitumor activity of recombinant interferon alpha2b (IFNalpha2b) has been well documented in patients with advanced and high-risk melanoma; however, its mechanism of action remains conjectural.
  • Trial E2690 evaluated the immunomodulatory effects of IFNalpha2b in vivo during treatment at high doses (the HDI arm; n = 51 patients) and at low doses (the LDI arm; n = 54 patients) in relation to standard observation (OBS; n = 43 patients).
  • METHODS: This study evaluated peripheral blood lymphocytes (PBLs) for phenotypic markers and cytotoxic functions at 1 month, 3 months, and 12 months in the HDI arm, the LDI arm, and the OBS arm and examined correlations between changes observed in PBLs or in tumors with regard to treatment dosage and disease outcome.
  • Tumor biopsy samples were studied for response to IFNalpha2b at a range of concentrations in vitro.
  • RESULTS: Baseline blood phenotypic and functional assays did not predict disease outcome; however, modulation of these immunologic assays by IFNalpha2b treatment was observed and was associated with IFNalpha2b dosage.
  • Blood natural killer (NK) cell function, T-cell function, and subset distribution were modulated early by patients in the HDI arm and later by patients in the LDI arm.
  • None of the variables tested in these studies predicted recurrence free survival.
  • CONCLUSIONS: These data demonstrate changes in immunologic parameters associated with IFNalpha2b treatment and dosage that may account for some of the differences in the clinical efficacy of this modality.
  • The current results also suggest the need for further study of newer molecular intermediates of IFNalpha2b and T-cell response to specific antigens of melanoma.
  • [MeSH-major] Biomarkers, Tumor / analysis. HLA Antigens / analysis. Intercellular Adhesion Molecule-1 / analysis. Interferon-alpha / pharmacology. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Chemotherapy, Adjuvant. Female. Humans. Killer Cells, Natural / physiology. Male. Middle Aged. Phenotype. Predictive Value of Tests. Recombinant Proteins. T-Lymphocytes / physiology. Treatment Outcome

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  • [Copyright] Copyright 2002 American Cancer Society.
  • [CommentIn] Cancer. 2002 Sep 1;95(5):947-9 [12209676.001]
  • (PMID = 12209697.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / R0-1 CA56774
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Biomarkers, Tumor; 0 / HLA Antigens; 0 / Interferon-alpha; 0 / Recombinant Proteins; 126547-89-5 / Intercellular Adhesion Molecule-1; 99210-65-8 / interferon alfa-2b
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52. Bender CM, Yasko JM, Kirkwood JM, Ryan C, Dunbar-Jacob J, Zullo T: Cognitive function and quality of life in interferon therapy for melanoma. Clin Nurs Res; 2000 Aug;9(3):352-63
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  • [Title] Cognitive function and quality of life in interferon therapy for melanoma.
  • The purpose of this pilot study was to describe short- and long-term changes in cognitive function and quality of life in patients with melanoma receiving interferon (IFN) alpha-2b.
  • This study used a three-group, repeated measures design in which cognitive function and quality of life were evaluated prior to initiation of treatment at 3-month intervals during treatment and 3 months following the completion of treatment.
  • The sample consisted of 16 adults with Stage II or III melanoma, randomized to one of three treatment groups.
  • Participants in Arm A received high-dose IFN alpha-2b, those in Arm B received low-dose IFN alpha-2b, and those in Arm C received no therapy (control).
  • In participants in Arm A, there was a significant deterioration in the physical well-being dimension of quality of life from baseline to 3 months after beginning therapy.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Interferon-alpha / therapeutic use. Melanoma / drug therapy. Melanoma / psychology. Skin Neoplasms / drug therapy. Skin Neoplasms / psychology
  • [MeSH-minor] Clinical Nursing Research. Cognition / drug effects. Humans. Quality of Life. Recombinant Proteins

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  • (PMID = 11276624.001).
  • [ISSN] 1054-7738
  • [Journal-full-title] Clinical nursing research
  • [ISO-abbreviation] Clin Nurs Res
  • [Language] eng
  • [Grant] United States / NINR NIH HHS / NR / NRO 6871
  • [Publication-type] Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 43K1W2T1M6 / interferon alfa-2b
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53. Mitchell MS, Abrams J, Thompson JA, Kashani-Sabet M, DeConti RC, Hwu WJ, Atkins MB, Whitman E, Ernstoff MS, Haluska FG, Jakowatz JG, Das Gupta TK, Richards JM, Samlowski WE, Costanzi JJ, Aronson FR, Deisseroth AB, Dudek AZ, Jones VE: Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon Alfa-2b compared with high-dose interferon Alfa-2b for Resected stage III cutaneous melanoma. J Clin Oncol; 2007 May 20;25(15):2078-85
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  • [Title] Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon Alfa-2b compared with high-dose interferon Alfa-2b for Resected stage III cutaneous melanoma.
  • PURPOSE: To compare the overall survival (OS) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b (IFN-alpha-2b) with the OS achieved using high-dose IFN-alpha-2b.
  • PATIENTS AND METHODS: An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003.
  • Patients were stratified by sex and number of nodes and were randomly assigned to receive either 2 years of treatment with active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN-alpha-2b (arm 1) or high-dose IFN-alpha-2b alone for 1 year (arm 2).
  • IFN-alpha-2b in arm 2 was administered according to the Eastern Cooperative Oncology Group 1684 study regimen.
  • RESULTS: Median follow-up time was 32 months for all patients and 42 months for surviving patients.
  • Median OS time exceeds 84 months in arm 1 and is 83 months in arm 2 (P = .56).
  • Five-year OS rate is 61% in arm 1 and 57% in arm 2.
  • Estimated 5-year relapse-free survival (RFS) rate is 50% in arm 1 and 48% in arm 2, with median RFS times of 58 and 50 months, respectively.
  • The incidence of serious adverse events as a result of treatment was the same in both arms, but more severe neuropsychiatric toxicity was seen in arm 2.
  • CONCLUSION: OS and RFS achieved by active specific immunotherapy and low-dose IFN-alpha-2b were indistinguishable from those achieved by high-dose IFN-alpha-2b.
  • Long RFS and OS times were observed in both treatment arms.
  • [MeSH-major] Cancer Vaccines / therapeutic use. Immunotherapy, Active. Interferon-alpha / therapeutic use. Melanoma / therapy. Skin Neoplasms / therapy
  • [MeSH-minor] Combined Modality Therapy. Cytoskeletal Proteins. Dose-Response Relationship, Drug. Drug Combinations. Female. Follow-Up Studies. Humans. Lipid A / analogs & derivatives. Lymphatic Metastasis. Male. Middle Aged. Neoplasm Recurrence, Local. Recombinant Proteins. Survival Rate

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  • [CommentIn] Expert Rev Vaccines. 2007 Dec;6(6):907-11 [18377354.001]
  • [CommentIn] J Clin Oncol. 2007 Oct 10;25(29):4693; author reply 4693-5 [17925569.001]
  • (PMID = 17513813.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Cancer Vaccines; 0 / Cytoskeletal Proteins; 0 / Drug Combinations; 0 / Interferon-alpha; 0 / Lipid A; 0 / Melacine; 0 / Recombinant Proteins; 0 / detox adjuvant; 99210-65-8 / interferon alfa-2b
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54. Bafaloukos D, Tsoutsos D, Kalofonos H, Chalkidou S, Panagiotou P, Linardou E, Briassoulis E, Efstathiou E, Polyzos A, Fountzilas G, Christodoulou C, Kouroussis C, Iconomou T, Gogas H: Temozolomide and cisplatin versus temozolomide in patients with advanced melanoma: a randomized phase II study of the Hellenic Cooperative Oncology Group. Ann Oncol; 2005 Jun;16(6):950-7
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  • [Title] Temozolomide and cisplatin versus temozolomide in patients with advanced melanoma: a randomized phase II study of the Hellenic Cooperative Oncology Group.
  • We designed a randomized phase II study to evaluate and compare the activity and safety profile of the combination versus single-agent TMZ in patients with advanced melanoma.
  • Patient and tumor characteristics were well balanced between the two arms.
  • RESULTS: Tumor responses (complete and partial responses) were seen in 16 patients (26%) in arm A and 19 patients (29%) in arm B.
  • The median time to progression (TTP) was 3.8 months in arm A and 5.8 months in arm B.
  • The median overall survival (OS) was 11.5 months in arm A and 12 months in arm B.
  • The difference between treatment arms regarding objective response rates, TTP and OS were not statistically significant.
  • Toxicity was comparable between the two arms for anemia, leukopenia, neutropenia, thrombocytopenia, fatigue, constipation and arthralgias/myalgias.
  • There was significantly more grade 3 and 4 emesis in the combination arm.
  • CONCLUSIONS: No clear benefit in terms of response rates, median TTP or OS was shown with the combination of TMZ + CDDP.

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  • (PMID = 15829494.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 7GR28W0FJI / Dacarbazine; 85622-93-1 / temozolomide; Q20Q21Q62J / Cisplatin
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55. Hersey P, Sosman J, O'Day S, Richards J, Bedikian A, Gonzalez R, Sharfman W, Weber R, Logan T, Buzoianu M, Hammershaimb L, Kirkwood JM, Etaracizumab Melanoma Study Group: A randomized phase 2 study of etaracizumab, a monoclonal antibody against integrin alpha(v)beta(3), + or - dacarbazine in patients with stage IV metastatic melanoma. Cancer; 2010 Mar 15;116(6):1526-34
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  • [Title] A randomized phase 2 study of etaracizumab, a monoclonal antibody against integrin alpha(v)beta(3), + or - dacarbazine in patients with stage IV metastatic melanoma.
  • METHODS: This phase 2, randomized, open-label, 2-arm study was designed to capture safety data and evaluate the antitumor efficacy of etaracizumab (Abegrin), an IgG1 humanized monoclonal antibody against the alpha(v)beta(3) integrin, in patients with previously untreated metastatic melanoma.
  • The majority of AEs were grade 1 or 2 in severity in both study arms; most events were not considered serious, except for cardiovascular (myocardial infarction, atrial fibrillation) and thromboembolic events, which occurred in 3 and 5 patients, respectively.
  • None of the patients in the etaracizumab-alone study arm and 12.7% of patients in the etaracizumab + dacarbazine study arm achieved an objective response.
  • The median duration of objective response in the etaracizumab + dacarbazine study arm was 4.2 months.
  • Stable disease rate, time to progression (TTP), and progression-free survival (PFS) appeared to be similar between the 2 treatment arms.
  • Stable disease occurred in 45.6% of patients in the etaracizumab-alone study arm and 40.0% of patients in the etaracizumab + dacarbazine study arm.
  • Median TTP and median PFS were both 1.8 months in the etaracizumab-alone study arm and 2.5 and 2.6 months in the etaracizumab + dacarbazine study arm, respectively.
  • Median overall survival was 12.6 months in the etaracizumab-alone study arm and 9.4 months in the etaracizumab + dacarbazine study arm.
  • CONCLUSIONS: The survival results in both treatment arms of this study were considered unlikely to result in clinically meaningful improvement over dacarbazine alone.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Dacarbazine / therapeutic use. Integrin alphaVbeta3 / immunology. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal, Humanized. Disease-Free Survival. Female. Humans. Male. Middle Aged

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  • (PMID = 20108344.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0 / Integrin alphaVbeta3; 303127-73-3 / etaracizumab; 7GR28W0FJI / Dacarbazine
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56. Slingluff CL Jr, Petroni GR, Yamshchikov GV, Barnd DL, Eastham S, Galavotti H, Patterson JW, Deacon DH, Hibbitts S, Teates D, Neese PY, Grosh WW, Chianese-Bullock KA, Woodson EM, Wiernasz CJ, Merrill P, Gibson J, Ross M, Engelhard VH: Clinical and immunologic results of a randomized phase II trial of vaccination using four melanoma peptides either administered in granulocyte-macrophage colony-stimulating factor in adjuvant or pulsed on dendritic cells. J Clin Oncol; 2003 Nov 1;21(21):4016-26
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  • [Title] Clinical and immunologic results of a randomized phase II trial of vaccination using four melanoma peptides either administered in granulocyte-macrophage colony-stimulating factor in adjuvant or pulsed on dendritic cells.
  • PURPOSE: To determine clinical and immunologic responses to a multipeptide melanoma vaccine regimen, a randomized phase II trial was performed.
  • PATIENTS AND METHODS: Twenty-six patients with advanced melanoma were randomly assigned to vaccination with a mixture of four gp100 and tyrosinase peptides restricted by HLA-A1, HLA-A2, and HLA-A3, plus a tetanus helper peptide, either in an emulsion with granulocyte-macrophage colony-stimulating factor (GM-CSF) and Montanide ISA-51 adjuvant (Seppic Inc, Fairfield, NJ), or pulsed on monocyte-derived dendritic cells (DCs).
  • T-lymphocyte responses were assessed, by interferon gamma ELIspot assay (Chiron, Emeryville, CA), in peripheral-blood lymphocytes (PBLs) and in a lymph node draining a vaccine site (sentinel immunized node [SIN]).
  • RESULTS: In patients vaccinated with GM-CSF in adjuvant, T-cell responses to melanoma peptides were observed in 42% of PBLs and 80% of SINs, but in patients vaccinated with DCs, they were observed in only 11% and 13%, respectively.
  • The overall immune response was greater in the GM-CSF arm (P <.02).
  • Vitiligo developed in two of 13 patients in the GM-CSF arm but in no patients in the DC arm.
  • Helper T-cell responses to the tetanus peptide were detected in PBLs after vaccination and correlated with T-cell reactivity to the melanoma peptides.
  • Objective clinical responses were observed in two patients in the GM-CSF arm and one patient in the DC arm.
  • Stable disease was observed in two patients in the GM-CSF arm and one patient in the DC arm.
  • CONCLUSION: The high frequency of cytotoxic T-lymphocyte responses and the occurrence of clinical tumor regressions support continued investigation of multipeptide vaccines administered with GM-CSF in adjuvant.
  • [MeSH-major] Cancer Vaccines / administration & dosage. Granulocyte-Macrophage Colony-Stimulating Factor / administration & dosage. Mannitol / analogs & derivatives. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Thoracic Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Dendritic Cells. Drug Administration Schedule. Female. Humans. Interleukin-2 / administration & dosage. Lymph Nodes / immunology. Male. Membrane Glycoproteins / administration & dosage. Middle Aged. Monophenol Monooxygenase / administration & dosage. Neoplasm Proteins / administration & dosage. Oleic Acids / administration & dosage. Peptide Fragments / administration & dosage. Survival Analysis. T-Lymphocytes / immunology. Treatment Outcome. gp100 Melanoma Antigen

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  • [CommentIn] J Clin Oncol. 2004 Sep 15;22(18):3834-5; author reply 3835 [15365084.001]
  • (PMID = 14581425.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCRR NIH HHS / RR / M01 RR00847; United States / NCI NIH HHS / CA / P30CA44579; United States / NCI NIH HHS / CA / R01 CA78519
  • [Publication-type] Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Cancer Vaccines; 0 / Interleukin-2; 0 / Membrane Glycoproteins; 0 / Neoplasm Proteins; 0 / Oleic Acids; 0 / PMEL protein, human; 0 / Peptide Fragments; 0 / gp100 Melanoma Antigen; 0 / montanide ISA 51; 3OWL53L36A / Mannitol; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor; EC 1.14.18.1 / Monophenol Monooxygenase
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57. Chiarion-Sileni V, Del Bianco P, Romanini A, Guida M, Paccagnella A, Dalla Palma M, Naglieri E, Ridolfi R, Silvestri B, Michiara M, De Salvo GL: Tolerability of intensified intravenous interferon alfa-2b versus the ECOG 1684 schedule as adjuvant therapy for stage III melanoma: a randomized phase III Italian Melanoma Inter-group trial (IMI - Mel.A.) [ISRCTN75125874]. BMC Cancer; 2006;6:44
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  • [Title] Tolerability of intensified intravenous interferon alfa-2b versus the ECOG 1684 schedule as adjuvant therapy for stage III melanoma: a randomized phase III Italian Melanoma Inter-group trial (IMI - Mel.A.) [ISRCTN75125874].
  • BACKGROUND: High-dose interferon alfa-2b (IFNalfa-2b), according to the ECOG 1684 schedule, is the only approved adjuvant treatment for stage III melanoma patients by the FDA and EMEA.
  • However, the risk/benefit profile has been questioned limiting its world-wide use.
  • In the late nineties, the Italian Melanoma Inter-group started a spontaneous randomized clinical trial (RCT) to verify if a more intense, but shorter than the ECOG 1684 regimen, could improve survival without increasing the toxicity profile.
  • The safety analysis in the first 169 patients who completed the treatment is here described.
  • METHODS: Stage III melanoma patients were randomized to receive IFNalfa-2b 20 MU/m2/d intravenously (IV) 5 days/week x 4 weeks, repeated for three times on weeks 9 to 12, 17 to 20, 25 to 28 (Dose-Dense/Dose-Intense, DD/DI, arm), or IFNalfa-2b 20 MU/m2/d IV 5 days/week x 4 weeks followed by 10 MU/m2 subcutaneously (SC) three times per week x 48 weeks (High Dose Interferon, HDI, arm).
  • RESULTS: The most common toxicities in both arms were flu-like and gastrointestinal symptoms, leukopenia, liver and neuro-psychiatric morbidities; with regard to severe toxicity, only leukopenia was statistically more frequent in DD/DI arm than in HDI arm (24% vs 9%) (p = 0.0074), yet, this did not cause an increase in the infection risk.
  • Discontinuation of treatment, due to toxicity, was observed in 13 and 17% of the patients in the DD/DI and HDI arm, respectively.
  • The median actual dose intensity delivered in the DD/DI arm (36.4 MU/m2/week) was statistically higher than that delivered in the HDI arm (30.7 MU/m2/week) (p = 0.003).
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Antineoplastic Agents / adverse effects. Interferon-alpha / administration & dosage. Interferon-alpha / adverse effects. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Chemotherapy, Adjuvant. Drug Administration Schedule. Female. Humans. Infusions, Intravenous. Italy. Male. Middle Aged. Recombinant Proteins. Tomography, X-Ray Computed

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  • (PMID = 16504154.001).
  • [ISSN] 1471-2407
  • [Journal-full-title] BMC cancer
  • [ISO-abbreviation] BMC Cancer
  • [Language] eng
  • [Databank-accession-numbers] ISRCTN/ ISRCTN75125874
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 99210-65-8 / interferon alfa-2b
  • [Other-IDs] NLM/ PMC1421423
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58. Punt CJ, Suciu S, Gore MA, Koller J, Kruit WH, Thomas J, Patel P, Lienard D, Eggermont AM, Keilholz U: Chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha2b and interleukin-2 versus two cycles of dacarbazine followed by chemoimmunotherapy in patients with metastatic melanoma: a randomised phase II study of the European Organization for Research and Treatment of Cancer Melanoma Group. Eur J Cancer; 2006 Nov;42(17):2991-5
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  • [Title] Chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha2b and interleukin-2 versus two cycles of dacarbazine followed by chemoimmunotherapy in patients with metastatic melanoma: a randomised phase II study of the European Organization for Research and Treatment of Cancer Melanoma Group.
  • BACKGROUND: Chemoimmunotherapy for patients with metastatic melanoma is associated with high toxicity, and only a subset of patients will benefit.
  • PATIENTS AND METHODS: Patients with metastatic melanoma were randomised to either receive chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha and interleukin-2 (arm A) or initial treatment with two cycles of dacarbazine monotherapy followed irrespective of response by the same 4-drug regimen of chemoimmunotherapy (arm B).
  • Chemoimmunotherapy was continued in the absence of disease progression for a maximum of four cycles.
  • Primary end-point was the disease stabilisation rate.
  • Disease stabilisation (complete/partial response or stable disease) was achieved in 19 patients (42.2%) in arm A and 9 patients (20.5%) in arm B.
  • In arm B 32 of the 44 patients continued chemoimmunotherapy after two cycles of dacarbazine.
  • Of 20 patients with progressive disease (PD) after two cycles of dacarbazine in arm B, only 2 patients achieved an objective response.
  • Median overall survival (OS) in arms A and B was 10.5 months and 9.5 months, respectively.
  • CONCLUSIONS: Despite a lower initial stabilisation rate, the strategy of starting with 2 courses of DTIC prior to a 4-drug regimen led to comparable median overall survival.
  • Only few transient responses were achieved with the 4-drug regimen in patients with disease progression on DTIC, suggesting frequent cross resistance.
  • [MeSH-major] Antineoplastic Agents, Alkylating / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Dacarbazine / therapeutic use. Immunotherapy / methods. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Cisplatin / administration & dosage. Combined Modality Therapy. Female. Humans. Interferon-alpha / administration & dosage. Interleukin-2 / administration & dosage. Male. Middle Aged. Patient Compliance. Recombinant Proteins

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  • (PMID = 17023156.001).
  • [ISSN] 0959-8049
  • [Journal-full-title] European journal of cancer (Oxford, England : 1990)
  • [ISO-abbreviation] Eur. J. Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; 0 / Interferon-alpha; 0 / Interleukin-2; 0 / Recombinant Proteins; 7GR28W0FJI / Dacarbazine; 99210-65-8 / interferon alfa-2b; Q20Q21Q62J / Cisplatin
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59. Hauschild A, Weichenthal M, Rass K, Linse R, Berking C, Böttjer J, Vogt T, Spieth K, Eigentler T, Brockmeyer NH, Stein A, Näher H, Schadendorf D, Mohr P, Kaatz M, Tronnier M, Hein R, Schuler G, Egberts F, Garbe C: Efficacy of low-dose interferon {alpha}2a 18 versus 60 months of treatment in patients with primary melanoma of &gt;= 1.5 mm tumor thickness: results of a randomized phase III DeCOG trial. J Clin Oncol; 2010 Feb 10;28(5):841-6
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  • [Title] Efficacy of low-dose interferon {alpha}2a 18 versus 60 months of treatment in patients with primary melanoma of >= 1.5 mm tumor thickness: results of a randomized phase III DeCOG trial.
  • PURPOSE Low-dose (LD) interferon (IFN) alfa (LDI) has demonstrated a consistent disease-free survival benefit for patients with clinically lymph node-negative melanoma in clinical trials.
  • However, the optimal duration of treatment is still under discussion, and no previous trial has evaluated this question specifically.
  • A prolongation of LDI from 18 months to 60 months might be of clinical benefit for patients with intermediate or high-risk melanoma.
  • PATIENTS AND METHODS Eight hundred fifty patients with resected cutaneous melanoma of at least 1.5 mm tumor thickness were included in this prospective randomized, multicenter trial in Germany and Austria.
  • They were randomly assigned to receive 3 MU IFNalpha2a three times a week subcutaneously for either 18 months (arm A) or 60 months (arm B).
  • SLNB was performed in 635 patients (75.6%), with a positivity rate of 18.0% in arm A and 17.5% in arm B.
  • Neither relapse-free survival (arm A, 75.6% v arm B, 72.6%; P = .72; hazard ratio, 1.05; 95% CI, 0.80 to 1.39) nor distant-metastasis-free survival (81.9% v 79.7%; P = .56; HR, 1.10; 95% CI, 0.80 to 1.52) or overall survival (85.9% v 84.9%; P = .86; HR, 1.03; 95% CI, 0.71 to 1.50) showed significant differences.
  • CONCLUSION A prolongation of conventional LDI therapy from 18 to 60 months showed no clinical benefit in patients with intermediate and high-risk primary melanoma.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Interferon-alpha / administration & dosage. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Austria. Chemotherapy, Adjuvant. Disease-Free Survival. Drug Administration Schedule. Female. Germany. Humans. Injections, Subcutaneous. Kaplan-Meier Estimate. Male. Middle Aged. Proportional Hazards Models. Prospective Studies. Recombinant Proteins. Risk Assessment. Sentinel Lymph Node Biopsy. Time Factors. Treatment Outcome. Young Adult

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  • (PMID = 20048184.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 76543-88-9 / interferon alfa-2a
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60. Bajetta E, Del Vecchio M, Vitali M, Martinetti A, Ferrari L, Queirolo P, Sertoli MR, Cainelli T, Cellerino R, Cascinelli N: A feasibility study using polychemotherapy (cisplatin + vindesine + dacarbazine) plus interferon-alpha or monochemotherapy with dacarbazine plus interferon-alpha in metastatic melanoma. Tumori; 2001 Jul-Aug;87(4):219-22
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  • [Title] A feasibility study using polychemotherapy (cisplatin + vindesine + dacarbazine) plus interferon-alpha or monochemotherapy with dacarbazine plus interferon-alpha in metastatic melanoma.
  • AIMS AND BACKGROUND: This trial evaluated the feasibility and tolerability of an immunochemotherapeutic approach that uses cisplatin, vindesine, and dacarbazine (DTIC), or only DTIC, in combination with interferon alpha-2a (IFN-alpha), in patients with metastatic melanoma, considering the significant toxicity of several different regimens used up to now.
  • METHODS: Between May 1995 and September 1997, 51 melanoma patients (50 of whom were assessable) entered a multicentric trial and were randomized to receive cisplatin (30 mg/m2 daily for 3 days) + vindesine (2.5 mg/m2 only day 1) + DTIC (250 mg/m2 daily for 3 consecutive days) + IFN-alpha (3 MIU i.m.
  • 3x/wk continuously) (CVD arm) versus DTIC (800 mg/m2 day 1) + IFN-alpha (3 MIU i.m.
  • 3x/wk continuously) (DTIC arm).
  • The chemotherapy was recycled every 21 days.
  • Patient reevaluation was performed every two cycles, and the treatment was continued in case of objective response or stabilization of disease.
  • RESULTS: We observed 3 complete responses, 2 partial responses and 5 stable diseases in the CVD arm, and 2 partial responses and 4 stabilizations of disease in the DTIC arm.
  • Future trials will be conducted associating the CVD regimen with biological response modifiers (IFN, IL-2) in order to improve the results.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Interferon-alpha / therapeutic use. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Cisplatin / administration & dosage. Combined Modality Therapy. Dacarbazine / administration & dosage. Feasibility Studies. Female. Humans. Immunotherapy. Male. Middle Aged. Neoplasm Metastasis. Treatment Outcome. Vindesine / administration & dosage

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  • (PMID = 11693798.001).
  • [ISSN] 0300-8916
  • [Journal-full-title] Tumori
  • [ISO-abbreviation] Tumori
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 7GR28W0FJI / Dacarbazine; Q20Q21Q62J / Cisplatin; RSA8KO39WH / Vindesine
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61. Pectasides D, Dafni U, Bafaloukos D, Skarlos D, Polyzos A, Tsoutsos D, Kalofonos H, Fountzilas G, Panagiotou P, Kokkalis G, Papadopoulos O, Castana O, Papadopoulos S, Stavrinidis E, Vourli G, Ioannovich J, Gogas H: Randomized phase III study of 1 month versus 1 year of adjuvant high-dose interferon alfa-2b in patients with resected high-risk melanoma. J Clin Oncol; 2009 Feb 20;27(6):939-44
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  • [Title] Randomized phase III study of 1 month versus 1 year of adjuvant high-dose interferon alfa-2b in patients with resected high-risk melanoma.
  • PURPOSE: A high-dose interferon alfa (IFN-alpha) regimen as reported in E1684 was unique for the incorporation of an induction phase of maximally tolerated dosages of intravenous (IV) therapy for the initial 4 weeks.
  • This is the only trial that has shown prolongation of overall survival and relapse-free survival (RFS) in comparison with observation.
  • Analysis of the hazard curves for RFS and overall survival (OS) in E1684 revealed separation of the high-dose and observation arms, suggesting that the induction phase may represent a critical component of this regimen, although this has not been tested prospectively.
  • PATIENTS AND METHODS: We conducted a prospective randomized study of IV induction therapy versus a full year of high-dose IFN, with primary end points of RFS and OS for patients with stage IIB, IIC, and III melanoma, within 56 days of curative surgery.
  • Patients were randomly assigned to receive IFN-alpha-2b 15 x 10(6) U/m2 IV x 5/7 days weekly x 4 weeks (arm A) versus the same regimen followed by IFN-alpha-2b 10 x 10(6) U (flat dose) administered subcutaneously three times a week for 48 weeks (arm B).
  • RESULTS: Between 1998 and 2004, 364 patients were enrolled (353 eligible: arm A, n = 177; arm B, n = 176).
  • At a median follow-up of 63 months (95% CI, 58.1 to 67.7), the median RFS was 24.1 months versus 27.9 months (P = .9) and the median OS was 64.4 months versus 65.3 months (P = .49).
  • Patients in arm B had more grade 1 to 2 hepatotoxicity, nausea/vomiting, alopecia, and neurologic toxicity.
  • CONCLUSION: There were no significant differences in OS and RFS between the regimens of 1 month and 1 year of treatment.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Interferon-alpha / administration & dosage. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Chemotherapy, Adjuvant. Drug Administration Schedule. Female. Humans. Male. Middle Aged. Recombinant Proteins. Survival Analysis. Time Factors

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  • [CommentIn] J Clin Oncol. 2009 Sep 1;27(25):e82-3; author reply e84 [19635995.001]
  • [CommentIn] J Clin Oncol. 2009 Aug 20;27(24):e70; author reply e71 [19620476.001]
  • (PMID = 19139440.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 99210-65-8 / interferon alfa-2b
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62. Hauschild A, Trefzer U, Garbe C, Kaehler KC, Ugurel S, Kiecker F, Eigentler T, Krissel H, Schott A, Schadendorf D: Multicenter phase II trial of the histone deacetylase inhibitor pyridylmethyl-N-{4-[(2-aminophenyl)-carbamoyl]-benzyl}-carbamate in pretreated metastatic melanoma. Melanoma Res; 2008 Aug;18(4):274-8
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  • [Title] Multicenter phase II trial of the histone deacetylase inhibitor pyridylmethyl-N-{4-[(2-aminophenyl)-carbamoyl]-benzyl}-carbamate in pretreated metastatic melanoma.
  • Systemic treatment of metastatic melanoma is of low efficacy, and new therapeutic strategies are needed.
  • This study was aimed to evaluate the efficacy, safety, and pharmacokinetics of the histone deacetylase inhibitor pyridylmethyl-N-{4-[(2-aminophenyl)-carbamoyl]-benzyl}-carbamate (MS-275) in patients with pretreated metastatic melanoma.
  • Patients with unresectable AJCC stage IV melanoma refractory to at least one earlier systemic therapy were randomized to receive MS-275 3 mg biweekly (days 1+15, arm A) or 7 mg weekly (days 1+8+15, arm B), in 4-week cycles.
  • The primary study endpoint was objective tumor response, secondary endpoints were safety and time-to-progression.
  • On the basis of Simon's two-stage design, the study initially allowed an entry of 14 patients per arm; if there was at least one responder, additional 33 patients were to be enrolled.
  • Among 28 patients enrolled, no objective response was detected.
  • Four (29%) patients in arm A and three (21%) patients in arm B showed disease stabilizations.
  • Median time-to-progression was comparable in both arms with 55.5 versus 51.5 days, respectively; median overall survival was 8.84 months.
  • No treatment-related serious adverse events occurred.
  • Single-agent treatment with MS-275 was well-tolerated and showed long-term tumor stabilizations, but no objective responses in pretreated metastatic melanoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Benzamides / therapeutic use. Histone Deacetylase Inhibitors. Melanoma / drug therapy. Pyridines / therapeutic use. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Enzyme Inhibitors / administration & dosage. Enzyme Inhibitors / adverse effects. Enzyme Inhibitors / pharmacokinetics. Enzyme Inhibitors / therapeutic use. Female. Histone Deacetylases / metabolism. Humans. Kaplan-Meier Estimate. Male. Middle Aged

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  • (PMID = 18626312.001).
  • [ISSN] 1473-5636
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Benzamides; 0 / Enzyme Inhibitors; 0 / Histone Deacetylase Inhibitors; 0 / Pyridines; 1ZNY4FKK9H / entinostat; EC 3.5.1.98 / Histone Deacetylases
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63. Chiarion-Sileni V, Del Bianco P, De Salvo GL, Lo Re G, Romanini A, Labianca R, Nortilli R, Corgna E, Dalla Palma M, Lo Presti G, Ridolfi R, Italian Melanoma Intergroup (IMI): Quality of life evaluation in a randomised trial of chemotherapy versus bio-chemotherapy in advanced melanoma patients. Eur J Cancer; 2003 Jul;39(11):1577-85
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  • [Title] Quality of life evaluation in a randomised trial of chemotherapy versus bio-chemotherapy in advanced melanoma patients.
  • This study analyses the health related quality of life (HRQOL) of advanced melanoma patients, in a randomised trial comparing bio-chemotherapy (bio-CT) versus chemotherapy (CT).
  • The trial enrolled 178 patients and the median survival was not statistically different between the two arms.
  • HRQOL was assessed at baseline and before each cycle of therapy, using the Rotterdam Symptom Checklist (RSCL) questionnaire completed with 140 patients.
  • During treatment, the difference between the two arms in the changes from baseline was statistically significant (P=0.03) only in the overall quality of life score, with a decrease of 6.28 points in the bio-CT arm.
  • The mean values decreased significantly in all domains in bio-CT arm, but only in activity level and physical symptom distress scores in the CT arm.
  • Testing HRQOL variables and prognostic clinical factors in a Cox model, only the serum level of lactic dehydrogenase, baseline overall quality of life and the physical symptom distress scores remained significant independent prognostic factors for survival.
  • A score of less than 75 points in the overall quality of life and in the physical symptom distress domains was associated with a Hazard Ratio (HR) of 2.31 (95% Confidence Interval (CI): 1.09-4.90) and 1.92 (95% CI: 1.10-3.36), respectively.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Quality of Life. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Carmustine / administration & dosage. Cisplatin / administration & dosage. Dacarbazine / administration & dosage. Female. Humans. Interferon-alpha / administration & dosage. Interleukin-2 / administration & dosage. Male. Middle Aged. Multivariate Analysis. Prognosis. Recombinant Proteins

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  • (PMID = 12855265.001).
  • [ISSN] 0959-8049
  • [Journal-full-title] European journal of cancer (Oxford, England : 1990)
  • [ISO-abbreviation] Eur. J. Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Interleukin-2; 0 / Recombinant Proteins; 7GR28W0FJI / Dacarbazine; 99210-65-8 / interferon alfa-2b; Q20Q21Q62J / Cisplatin; U68WG3173Y / Carmustine
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64. Testori A, Richards J, Whitman E, Mann GB, Lutzky J, Camacho L, Parmiani G, Tosti G, Kirkwood JM, Hoos A, Yuh L, Gupta R, Srivastava PK, C-100-21 Study Group: Phase III comparison of vitespen, an autologous tumor-derived heat shock protein gp96 peptide complex vaccine, with physician's choice of treatment for stage IV melanoma: the C-100-21 Study Group. J Clin Oncol; 2008 Feb 20;26(6):955-62
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  • [Title] Phase III comparison of vitespen, an autologous tumor-derived heat shock protein gp96 peptide complex vaccine, with physician's choice of treatment for stage IV melanoma: the C-100-21 Study Group.
  • PURPOSE: To assess the antitumor activity of vitespen (autologous, tumor- derived heat shock protein gp96 peptide complexes) by determining whether patients with stage IV melanoma treated with vitespen experienced longer overall survival than patients treated with physician's choice.
  • PATIENTS AND METHODS: Patients (N = 322) were randomly assigned 2:1 to receive vitespen or physician's choice (PC) of a treatment containing one or more of the following: dacarbazine, temozolomide, interleukin-2, or complete tumor resection.
  • RESULTS: Therapy with vitespen is devoid of significant toxicity.
  • Patients randomly assigned to the vitespen arm received variable number of injections (range, 0 to 87; median, 6) in part because of the autologous nature of vitespen therapy.
  • Intention-to-treat analysis showed that overall survival in the vitespen arm is statistically indistinguishable from that in the PC arm.
  • Exploratory landmark analyses show that patients in the M1a and M1b substages receiving a larger number of vitespen immunizations survived longer than those receiving fewer such treatments.
  • CONCLUSION: These results are consistent with the immunologic mechanism of action of vitespen, indicating delayed onset of clinical activity after exposure to the vaccine.
  • The results suggest patients with M1a and M1b disease who are able to receive 10 or more doses of vitespen as the candidate population for a confirmatory study.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Cancer Vaccines / therapeutic use. Heat-Shock Proteins / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Dacarbazine / administration & dosage. Dacarbazine / analogs & derivatives. Female. Humans. Interleukin-2 / therapeutic use. Kaplan-Meier Estimate. Male. Middle Aged. Neoplasm Staging. Odds Ratio. Treatment Outcome

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  • [ErratumIn] J Clin Oncol. 2008 Aug 1;26(22): 3819
  • (PMID = 18281670.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA84479
  • [Publication-type] Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Cancer Vaccines; 0 / Heat-Shock Proteins; 0 / Interleukin-2; 492448-75-6 / vitespin; 7GR28W0FJI / Dacarbazine; 85622-93-1 / temozolomide
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65. Kirkwood JM, Ibrahim JG, Sondak VK, Richards J, Flaherty LE, Ernstoff MS, Smith TJ, Rao U, Steele M, Blum RH: High- and low-dose interferon alfa-2b in high-risk melanoma: first analysis of intergroup trial E1690/S9111/C9190. J Clin Oncol; 2000 Jun;18(12):2444-58
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  • [Title] High- and low-dose interferon alfa-2b in high-risk melanoma: first analysis of intergroup trial E1690/S9111/C9190.
  • PURPOSE: Pivotal trial E1684 of adjuvant high-dose interferon alfa-2b (IFNalpha2b) therapy in high-risk melanoma patients demonstrated a significant relapse-free and overall survival (RFS and OS) benefit compared with observation (Obs).
  • PATIENTS AND METHODS: A prospective, randomized, three-arm, intergroup trial evaluated the efficacy of high-dose IFNalpha2b (HDI) for 1 year and low-dose IFNalpha2b (LDI) for 2 years versus Obs in high-risk (stage IIB and III) melanoma with RFS and OS end points.
  • The 5-year estimated RFS rates for the HDI, LDI, and Obs arms were 44%, 40%, and 35%, respectively.
  • Neither HDI nor LDI has demonstrated an OS benefit compared with Obs at this time.
  • A major improvement in the median OS of patients in the E1690 Obs arm was noted in comparison with E1684 (6 years v 2.8 years).
  • An analysis of salvage therapy for patients who relapsed on E1690 demonstrated that a significantly larger proportion of patients in the Obs arm received IFNalpha-containing salvage therapy compared with the HDI arm; this therapy was unavailable to patients during E1684, and patients with undissected regional nodes were not included in E1684.
  • This study did not specify therapy at recurrence.
  • Analysis of treatments received at recurrence demonstrated significantly more frequent use of IFNalpha2b at relapse from Obs than from HDI, which may have confounded interpretation of the survival benefit of assigned treatments in E1690.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Interferon-alpha / administration & dosage. Melanoma / drug therapy
  • [MeSH-minor] Aged. Disease-Free Survival. Dose-Response Relationship, Drug. Female. Humans. Male. Middle Aged. Multivariate Analysis. Neoplasm Recurrence, Local / drug therapy. Neoplasm Recurrence, Local / pathology. Prospective Studies. Recombinant Proteins. Risk Factors. Salvage Therapy. Survival Rate. Treatment Outcome

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  • [CommentIn] J Clin Oncol. 2001 Feb 15;19(4):1226-8 [11181688.001]
  • (PMID = 10856105.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / U10CA392294
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 43K1W2T1M6 / interferon alfa-2b
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66. Schmittel A, Schmidt-Hieber M, Martus P, Bechrakis NE, Schuster R, Siehl JM, Foerster MH, Thiel E, Keilholz U: A randomized phase II trial of gemcitabine plus treosulfan versus treosulfan alone in patients with metastatic uveal melanoma. Ann Oncol; 2006 Dec;17(12):1826-9
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  • [Title] A randomized phase II trial of gemcitabine plus treosulfan versus treosulfan alone in patients with metastatic uveal melanoma.
  • This randomized phase II trial compared the GeT combination versus treosulfan alone (T) in this rare disease.
  • PATIENTS AND METHODS: Chemotherapy-naive patients with proven metastatic uveal melanoma were randomly assigned to receive 1000 mg/m(2) of gemcitabine plus 3500 mg/m(2) of treosulfan (GeT) or 3500 mg/m(2) of T.
  • Chemotherapy was administered on days 1 and 8 in both arms, cycles were repeated on day 29.
  • Primary end point was rate of responses and disease stabilizations.
  • Seven confirmed stable diseases (SDs) and one partial remission (PR) were observed in 24 patients treated with the GeT regimen, whereas no PR and only three SDs were observed in the T arm (P = 0.08).
  • Median progression-free survival (PFS) was 3 months (95% CI 1.1-4.9) and 2 months (95% CI 1.7-2.3) in the GeT and T arm (P = 0.008, log-rank).
  • Six and 12 months PFS was 34.8% and 17.9% and 16.7% and 0% always favoring the GeT arm.
  • CONCLUSIONS: This first randomized trial in metastatic uveal melanoma showed a superior PFS and a trend for a higher response/stabilization rate of the GeT combination over T.

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  • (PMID = 16971664.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine; CO61ER3EPI / treosulfan; G1LN9045DK / Busulfan
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67. Moschos SJ, Odoux C, Land SR, Agarwala S, Friedland D, Volker KM, Sidor C, Wong M, Kirkwood JM: Endostatin plus interferon-alpha2b therapy for metastatic melanoma: a novel combination of antiangiogenic and immunomodulatory agents. Melanoma Res; 2007 Jun;17(3):193-200
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  • [Title] Endostatin plus interferon-alpha2b therapy for metastatic melanoma: a novel combination of antiangiogenic and immunomodulatory agents.
  • In patients with stage IIB-III disease, adjuvant high-dose interferon-alpha2b has shown clinical benefit, although metastatic melanoma is currently without any known survival-prolonging therapy.
  • Angiogenesis has been considered important in melanoma progression, and endostatin is an angiogenesis inhibitor with antitumor activity that has shown promising results in murine model systems, prompting investigation of a formulation of rh-Endostatin (EntreMed, Rockville, Maryland, USA) alone and with interferon in metastatic melanoma.
  • Patients were randomly assigned to receive interferon alpha2b (Schering-Plough) 10 million units/m(2) subcutaneously three times a week plus rh-Endostatin 45 mg/m(2) subcutaneously every 12 h (arm A) vs. rh-Endostatin alone (arm B).
  • Twenty-one patients (age range 31-77 years, median age 54, 12 men and nine women, 17 cutaneous, and four ocular melanomas) were enrolled.
  • No antitumor responses were observed, and no significant differences were noted in time to progression or overall survival.
  • Two patients had stable disease enduring more than 30 weeks on treatment.
  • Serum endostatin levels increased significantly 4 weeks after treatment in both groups.
  • Basic fibroblast growth factor levels in urine were significantly lower following treatment in patients on arm B (P=0.043).
  • The percentage of circulating endothelial cells was increased in five evaluable patients 4 weeks after treatment.
  • Low titer (<or=1:25) IgG antibodies against the rh-Endo formulation were detected in two patients (one per arm) in cycle 4.
  • In conclusion, interferon did not improve response rate of rh-Endo although prolonged disease stability was observed in two patients.
  • Better laboratory correlates of antiangiogenic response are needed, and the predictive value of circulating endothelial cells warrants further evaluation.

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  • (PMID = 17505265.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] ENG
  • [Grant] United States / NCATS NIH HHS / TR / UL1 TR000005; United States / NCI NIH HHS / CA / P30 CA4790413
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Angiogenesis Inhibitors; 0 / Endostatins; 0 / Immunologic Factors; 0 / Interferon-alpha; 0 / Recombinant Proteins; 99210-65-8 / interferon alfa-2b
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68. Kim EM, Sivanandham M, Stavropoulos CI, Bartolucci AA, Wallack MK: Overview analysis of adjuvant therapies for melanoma--a special reference to results from vaccinia melanoma oncolysate adjuvant therapy trials. Surg Oncol; 2001 Jul-Aug;10(1-2):53-9
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  • [Title] Overview analysis of adjuvant therapies for melanoma--a special reference to results from vaccinia melanoma oncolysate adjuvant therapy trials.
  • A phase III, randomized, double-blind, multi-institutional vaccinia melanoma oncolysate (VMO) trial was performed for patients with stage III (AJCC) melanoma.
  • When compared with the control vaccinia virus (V) therapy, VMO therapy did not show clinical efficacy in the final analysis of data from this trial.
  • However, the data did allude to significant therapeutic efficacy with VMO therapy if it had been compared with an observation arm.
  • Therefore, a comparative overview statistical analysis was performed to identify the therapeutic efficacy of VMO.
  • This review compares VMO results with data from the treatment and observation arms of other prominent randomized anti-melanoma biologic trials (i.e., ECOG EST 1684; SWOG, IFN-gamma (J. Natl.
  • Cancer Inst. 87 (1995) 1710); WHO IFN-alfa-2a (ASCO 14 (1995) 410); Mayo IFN-alfa-2a (J. Clin. Oncol.
  • The analysis was carried out comparing the disease-free interval (DFI) and overall survival (OS).
  • The analysis shows that the VMO results are fairly comparable to the results of the treatment arms from the ECOG and Mayo trials at the 5-year mark; percent DFI 0.37, 0.37, and 0.4, percent OS 0.48, 0.46, 0.47, respectively.
  • In some cases, VMO DFI is superior to the observation arms from other studies; ECOG, Mayo, and WHO; 0.37 versus 0.26, 0.3, 0.27 (4 years), respectively.
  • These comparative results suggest that the vaccinia arm is not a true observation arm in the VMO trial, and the VMO could have shown an enhanced efficacy had the trial included a no-treatment observation control arm.
  • [MeSH-major] Melanoma / drug therapy. Melanoma / mortality. Randomized Controlled Trials as Topic. Skin Neoplasms / drug therapy. Skin Neoplasms / mortality. Vaccinia virus. Viral Vaccines / therapeutic use
  • [MeSH-minor] Chemotherapy, Adjuvant. Humans. Multicenter Studies as Topic. Survival Rate

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  • (PMID = 11719029.001).
  • [ISSN] 0960-7404
  • [Journal-full-title] Surgical oncology
  • [ISO-abbreviation] Surg Oncol
  • [Language] eng
  • [Publication-type] Journal Article; Meta-Analysis
  • [Publication-country] Netherlands
  • [Chemical-registry-number] 0 / Viral Vaccines
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69. Kirkwood JM, Lee S, Moschos SJ, Albertini MR, Michalak JC, Sander C, Whiteside T, Butterfield LH, Weiner L: Immunogenicity and antitumor effects of vaccination with peptide vaccine+/-granulocyte-monocyte colony-stimulating factor and/or IFN-alpha2b in advanced metastatic melanoma: Eastern Cooperative Oncology Group Phase II Trial E1696. Clin Cancer Res; 2009 Feb 15;15(4):1443-51
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  • [Title] Immunogenicity and antitumor effects of vaccination with peptide vaccine+/-granulocyte-monocyte colony-stimulating factor and/or IFN-alpha2b in advanced metastatic melanoma: Eastern Cooperative Oncology Group Phase II Trial E1696.
  • PURPOSE: No therapy has ever shown prolongation of survival in stage IV metastatic melanoma.
  • The association of cytokine-induced autoimmunity with improved prognosis led us to investigate the effect of multi-epitope melanoma vaccines alone and in combination with cytokines in this Eastern Cooperative Oncology Group multicenter phase II trial.
  • EXPERIMENTAL DESIGN: Eligible patients were required to have failed prior therapies and to be HLA-A2 positive.
  • Peptide vaccine alone (arm A), or combined with granulocyte-monocyte colony-stimulating factor (GM-CSF; Immunex) 250 microg/d subcutaneously for 14 of 28 days each month (arm B), or combined with IFN-alpha2b (Intron A; Schering-Plough) 10 million units/m2 three times a week (arm C), or combined with both IFN-alpha2b and GM-CSF (arm D).
  • The primary endpoint was immune response measured by enzyme-linked immunospot assay; secondary endpoints were clinical antitumor response, disease-free survival, and overall survival.
  • Immune responses to at least one melanoma antigen were observed in 26 of 75 (35%) patients with serial samples.
  • Neither IFN-alpha2b nor GM-CSF significantly improved immune responses.
  • Six objective clinical responses were documented.
  • At a median follow-up of 25.4 months, the median overall survival of patients with vaccine immune response was significantly longer than that of patients with no immune response (21.3 versus 13.4 months; P=0.046).
  • CONCLUSION: Immune response to vaccination correlates with prolonged survival in patients with metastatic melanoma and is not enhanced by immunomodulatory cytokines as tested in this trial.

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  • (PMID = 19228745.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / U10 CA066636-15; United States / NCI NIH HHS / CA / CA66636; United States / NCI NIH HHS / CA / U10 CA021115; United States / NCI NIH HHS / CA / CA039229-22; United States / NCI NIH HHS / CA / U10 CA066636; None / None / / U10 CA023318-32; United States / NCI NIH HHS / CA / U10 CA039229; United States / NCI NIH HHS / CA / CA39229; United States / NCI NIH HHS / CA / U10 CA021115-34; None / None / / U10 CA021115-34; United States / NCI NIH HHS / CA / U10 CA023318-32; United States / NCI NIH HHS / CA / U10 CA039229-22; United States / NCI NIH HHS / CA / U10 CA023318; United States / NCI NIH HHS / CA / CA21115; United States / NCI NIH HHS / CA / U24 CA114737; United States / NCI NIH HHS / CA / CA23318; None / None / / U10 CA066636-15
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Cancer Vaccines; 0 / Interferon-alpha; 0 / Recombinant Proteins; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor; 99210-65-8 / interferon alfa-2b
  • [Other-IDs] NLM/ NIHMS104522; NLM/ PMC2759898
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70. Reichle A, Vogt T, Coras B, Terheyden P, Neuber K, Trefzer U, Schultz E, Berand A, Bröcker EB, Landthaler M, Andreesen R: Targeted combined anti-inflammatory and angiostatic therapy in advanced melanoma: a randomized phase II trial. Melanoma Res; 2007 Dec;17(6):360-4
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  • [Title] Targeted combined anti-inflammatory and angiostatic therapy in advanced melanoma: a randomized phase II trial.
  • An angiostatic approach was used to assess the impact of anti-inflammatory therapy in combination with metronomic low-dose chemotherapy.
  • A randomized multi-institutional phase II trial was designed to select metronomic chemotherapy (arm A: trofosfamide 50 mg orally three times daily, day 1+) or combined anti-inflammatory/angiostatic treatment (arm B: trofosfamide as above mentioned plus rofecoxib 25 mg orally, day 1+, and pioglitazone 60 mg orally, day 1+) for further evaluation.
  • A total of 76 patients, mostly (>60%) refractory to at least one previous chemotherapy with maximum tolerated doses, and progression of metastatic melanoma were included.
  • The estimated progression-free survival (PFS) rates at one year were 0% for metronomic chemotherapy (A), but 9% for additional anti-inflammatory therapy (B).
  • Vice versa the hazard ratio for the intent-to-treat analysis of A versus B was 1.9 (P=0.008).
  • By Cox analysis, the impact of anti-inflammatory therapy on PFS achieved significance (P=0.016) as well as C-reactive protein response on overall survival (P=0.045).
  • WHO grade 3 (no grade 4) toxicities were reported in arm A/B in 19 and 28%, respectively.
  • In conclusion, control of tumour-associated inflammatory processes (C-reactive protein response) is associated with longer PFS than achieved with metronomic chemotherapy alone in metastatic melanoma.
  • [MeSH-major] Anti-Inflammatory Agents, Non-Steroidal / therapeutic use. Antineoplastic Combined Chemotherapy Protocols. Cyclophosphamide / analogs & derivatives. Lactones / therapeutic use. Melanoma / drug therapy. Sulfones / therapeutic use. Thiazolidinediones / therapeutic use
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. C-Reactive Protein / analysis. Disease-Free Survival. Female. Humans. Kaplan-Meier Estimate. Male. Middle Aged. Salvage Therapy

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  • (PMID = 17992118.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Anti-Inflammatory Agents, Non-Steroidal; 0 / Lactones; 0 / Sulfones; 0 / Thiazolidinediones; 0QTW8Z7MCR / rofecoxib; 8N3DW7272P / Cyclophosphamide; 9007-41-4 / C-Reactive Protein; H64JRU6GJ0 / trofosfamide; X4OV71U42S / pioglitazone
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71. Stadler R, Luger T, Bieber T, Köhler U, Linse R, Technau K, Schubert R, Schroth K, Vakilzadeh F, Volkenandt M, Gollnick H, Von Eick H, Thoren F, Strannegård O: Long-term survival benefit after adjuvant treatment of cutaneous melanoma with dacarbazine and low dose natural interferon alpha: A controlled, randomised multicentre trial. Acta Oncol; 2006;45(4):389-99
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  • [Title] Long-term survival benefit after adjuvant treatment of cutaneous melanoma with dacarbazine and low dose natural interferon alpha: A controlled, randomised multicentre trial.
  • In a prospective, controlled, randomised, multicentre study 252 patients with totally resected cutaneous melanoma (248 in stage II-III and 4 in stage IV) were either treated with two doses of dacarbazine (DTIC) followed by a 6-month treatment with 3 MU thrice weekly of highly purified natural interferon-alpha (n = 128; arm A) or received no adjuvant treatment (n = 124; arm B).
  • Treatment was well tolerated.
  • After a median follow-up of 8.5 years ITT analysis showed that the difference in survival was statistically significant with respect to melanoma-related deaths (HR = 0.65, CI = 0.46-0.97, p = 0.022) and close to significance with respect to overall survival (HR 0.71, CI 0.49-1.00, p = 0.052).
  • The risk reduction of melanoma-associated death, calculated by Cox proportional hazards modelling, after adjusting for identified predictive variables, was almost 50% (p = 0.002).
  • The overall efficacy of the treatment appeared to be mainly attributable to effects observed in patients with deep and/or metastasizing tumours (HR 0.60, CI 0.40-0.90, p = 0.013).
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / mortality. Skin Neoplasms / mortality
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Chemotherapy, Adjuvant. Dacarbazine / administration & dosage. Female. Humans. Interferon-alpha / administration & dosage. Male. Middle Aged. Neoplasm Recurrence, Local / drug therapy. Neoplasm Recurrence, Local / mortality. Neoplasm Recurrence, Local / secondary. Neoplasm Staging. Prospective Studies. Survival Rate

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  • [CommentIn] Acta Oncol. 2006;45(4):369-72 [16760171.001]
  • (PMID = 16760174.001).
  • [ISSN] 0284-186X
  • [Journal-full-title] Acta oncologica (Stockholm, Sweden)
  • [ISO-abbreviation] Acta Oncol
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Norway
  • [Chemical-registry-number] 0 / Interferon-alpha; 7GR28W0FJI / Dacarbazine
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72. Kaufmann R, Spieth K, Leiter U, Mauch C, von den Driesch P, Vogt T, Linse R, Tilgen W, Schadendorf D, Becker JC, Sebastian G, Krengel S, Kretschmer L, Garbe C, Dummer R, Dermatologic Cooperative Oncology Group: Temozolomide in combination with interferon-alfa versus temozolomide alone in patients with advanced metastatic melanoma: a randomized, phase III, multicenter study from the Dermatologic Cooperative Oncology Group. J Clin Oncol; 2005 Dec 10;23(35):9001-7
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  • [Title] Temozolomide in combination with interferon-alfa versus temozolomide alone in patients with advanced metastatic melanoma: a randomized, phase III, multicenter study from the Dermatologic Cooperative Oncology Group.
  • PURPOSE: Temozolomide (TMZ) has shown efficacy in metastatic melanoma equal to that of dacarbazine (DTIC), the standard chemotherapeutic agent for melanoma.
  • As the combination with interferon-alfa (IFN-alpha) appears superior to single-agent DTIC regarding response rates, the purpose of this study was to compare TMZ alone and TMZ plus IFN-alpha in terms of objective response (OR), overall survival, and safety in a prospective, randomized, multicenter trial.
  • PATIENTS AND METHODS: Two hundred ninety-four patients with untreated stage IV metastatic melanoma (American Joint Committee on Cancer staging system) were randomly assigned to receive either oral TMZ alone (200 mg/m2/day; days 1 through 5 every 28 days) or in combination with subcutaneous IFN-alpha (5 MU/m2; days 1, 3, and 5 every week).
  • RESULTS: Two hundred eighty-two patients were eligible for an intent-to-treat analysis, 271 patients were treated per protocol.
  • In the TMZ + IFN-alpha arm, 33 (24.1%) of 137 patients responded to therapy (partial or complete remission) whereas in the monotherapy arm, in 18 (13.4%) of 134 patients, a response was evident.
  • Thus, the response rate was significantly higher in the combination arm (P = .036).
  • Median survival time was 8.4 months for patients treated with TMZ (95% CI, 7.07 to 9.27) and 9.7 months for those treated with the combination (95% CI, 8.26 to 11.18; P = .16).
  • Dose modifications and interval prolongations due to hematologic toxicity were significantly more frequent in the TMZ + IFN-alpha arm (P < .001).
  • CONCLUSION: In metastatic melanoma treatment with TMZ + IFN-alpha leads to a significantly superior OR rate compared to treatment with TMZ alone, which did not translate into prolonged survival in our study population.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Chi-Square Distribution. Dacarbazine / administration & dosage. Dacarbazine / analogs & derivatives. Female. Humans. Interferon-alpha / administration & dosage. Male. Middle Aged. Prognosis. Prospective Studies. Statistics, Nonparametric. Survival Rate. Treatment Outcome

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  • (PMID = 16260697.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 7GR28W0FJI / Dacarbazine; 85622-93-1 / temozolomide
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73. Noorda EM, Vrouenraets BC, Nieweg OE, Kroon BB: [Regional isolated perfusion: also applicable in elderly patients]. Ned Tijdschr Geneeskd; 2003 Mar 22;147(12):529-33
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  • In 3 patients over 75 years of age with a malignancy, limb salvage was achieved through the application of isolated limb perfusion with melphalan with or without tumour necrosis factor alpha: an 82-year-old woman with extensive locoregional melanoma metastases on her lower leg, a 78-year-old woman with a large, ulcerating recurrence of melanoma on her lower leg and an 83-year-old woman with recurrent sarcoma of the lower arm.
  • Isolated limb perfusion can be effectively and safely used in older patients with irresectable tumours of the extremities, offering them limb salvage for the remainder of their lives.
  • [MeSH-major] Antineoplastic Agents, Alkylating / administration & dosage. Bone Neoplasms / drug therapy. Chemotherapy, Cancer, Regional Perfusion / methods. Extremities. Melanoma / drug therapy. Melphalan / administration & dosage. Sarcoma / drug therapy
  • [MeSH-minor] Aged. Aged, 80 and over. Female. Humans. Limb Salvage / methods. Neoplasm Recurrence, Local / drug therapy

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  • (PMID = 12693077.001).
  • [ISSN] 0028-2162
  • [Journal-full-title] Nederlands tijdschrift voor geneeskunde
  • [ISO-abbreviation] Ned Tijdschr Geneeskd
  • [Language] dut
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Netherlands
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; Q41OR9510P / Melphalan
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74. Agarwala SS, Kirkwood JM: Update on adjuvant interferon therapy for high-risk melanoma. Oncology (Williston Park); 2002 Sep;16(9):1177-87; discussion 1190-2, 1197
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  • [Title] Update on adjuvant interferon therapy for high-risk melanoma.
  • Melanoma is almost 100% curable when diagnosed early, but when metastatic to distant organs, it is associated with a poor survival.
  • The interferons have shown the mostpromise in the treatment of melanoma and interferon-alpha has been the most extensively studied.
  • In recent trials, interferon alfa-2b (Intron A) administered at maximally tolerated doses for 1 year produced improvements in both relapse-free and overall survival.
  • A trial of the GMK vaccine vs high-dose interferon in patients with high-risk melanoma closed early when an interim analysis detected a markedly inferior response in the GMK arm compared to the high-dose interferon arm.
  • The use of surgical staging will help to better define prognostic groups and support ongoing efforts for more effective adjuvant therapy.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Interferon-alpha / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Chemotherapy, Adjuvant. Clinical Trials as Topic. Combined Modality Therapy. Cost-Benefit Analysis. Humans. Neoplasm Recurrence, Local. Recombinant Proteins

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  • (PMID = 12380946.001).
  • [ISSN] 0890-9091
  • [Journal-full-title] Oncology (Williston Park, N.Y.)
  • [ISO-abbreviation] Oncology (Williston Park, N.Y.)
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 43K1W2T1M6 / interferon alfa-2b
  • [Number-of-references] 26
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75. Schadendorf D, Ugurel S, Schuler-Thurner B, Nestle FO, Enk A, Bröcker EB, Grabbe S, Rittgen W, Edler L, Sucker A, Zimpfer-Rechner C, Berger T, Kamarashev J, Burg G, Jonuleit H, Tüttenberg A, Becker JC, Keikavoussi P, Kämpgen E, Schuler G, DC study group of the DeCOG: Dacarbazine (DTIC) versus vaccination with autologous peptide-pulsed dendritic cells (DC) in first-line treatment of patients with metastatic melanoma: a randomized phase III trial of the DC study group of the DeCOG. Ann Oncol; 2006 Apr;17(4):563-70
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  • [Title] Dacarbazine (DTIC) versus vaccination with autologous peptide-pulsed dendritic cells (DC) in first-line treatment of patients with metastatic melanoma: a randomized phase III trial of the DC study group of the DeCOG.
  • BACKGROUND: This randomized phase III trial was designed to demonstrate the superiority of autologous peptide-loaded dendritic cell (DC) vaccination over standard dacarbazine (DTIC) chemotherapy in stage IV melanoma patients.
  • The primary study end point was objective response (OR); secondary end points were toxicity, overall (OS) and progression-free survival (PFS).
  • RESULTS: At the time of the first interim analysis 55 patients had been enrolled into the DTIC and 53 into the DC-arm (ITT).
  • OR was low (DTIC: 5.5%, DC: 3.8%), but not significantly different in the two arms.
  • Unscheduled subset analyses revealed that patients with normal serum LDH and/or stage M1a/b survived longer in both arms than those with elevated serum LDH and/or stage M1c.
  • Only in the DC-arm did those patients with (i) an initial unimpaired general health status (Karnofsky = 100) or (ii) an HLA-A2+/HLA-B44- haplotype survive significantly longer than patients with a Karnofsky index <100 (P = 0.007 versus P = 0.057 in the DTIC-arm) or other HLA haplotypes (P = 0.04 versus P = 0.57 in DTIC-treated patients).
  • CONCLUSIONS: DC vaccination could not be demonstrated to be more effective than DTIC chemotherapy in stage IV melanoma patients.

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  • [CommentIn] Ann Oncol. 2006 Apr;17(4):539-41 [16556849.001]
  • (PMID = 16418308.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Cancer Vaccines; 0 / Peptides; 7GR28W0FJI / Dacarbazine
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76. Bottomley A, Coens C, Suciu S, Santinami M, Kruit W, Testori A, Marsden J, Punt C, Salès F, Gore M, Mackie R, Kusic Z, Dummer R, Patel P, Schadendorf D, Spatz A, Keilholz U, Eggermont A: Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol; 2009 Jun 20;27(18):2916-23
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  • [Title] Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group.
  • PURPOSE: Interferon (IFN) -based adjuvant therapy in melanoma is associated with significant side effects, which necessitates evaluation of health-related quality of life (HRQOL).
  • Our trial examined the HRQOL effects of adjuvant pegylated IFN-alpha-2b (PEG-IFN-alpha-2b) versus observation in patients with stage III melanoma.
  • METHODS: A total of 1,256 patients with stage III melanoma were randomly assigned after full lymphadenectomy to receive either observation (n = 629) or PEG-IFN-alpha-2b (n = 627): induction 6 micrograms/kg/wk [DOSAGE ERROR CORRECTED] for 8 weeks then maintenance 3 micrograms/kg/wk [DOSAGE ERROR CORRECTED] for an intended total duration of 5 years.
  • The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 was used to assess HRQOL.
  • RESULTS: At 3.8 years of median follow-up, for the primary end point, recurrence-free survival (RFS), risk was reduced by 18% (hazard rate = 0.82; P = .01) in the PEG-IFN-alpha-2b arm compared with observation.
  • Significant and clinically meaningful differences occurred with the PEG-IFN-alpha-2b treatment arm compared with the observation group, showing decreased global HRQOL at month 3 (-11.6 points; 99% CI, -8.2 to -15.0) and year 2 (-10.5 points; 99% CI, -6.6 to -14.4).
  • Many of the other scales showed statistically significant differences between scores when comparing the two arms.
  • From a clinical point of view, important differences were found for five scales: two functioning scales (social and role functioning) and three symptom scales (appetite loss, fatigue, and dyspnea), with the PEG-IFN-alpha-2b arm being most impaired.
  • There is an expected negative effect on global HRQOL and selected symptoms when patients undergo PEG-IFN-alpha-2b treatment.
  • [MeSH-major] Interferon-alpha / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Chemotherapy, Adjuvant / methods. Female. Humans. Male. Middle Aged. Neoplasm Staging. Polyethylene Glycols. Quality of Life. Recombinant Proteins

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  • [CommentIn] J Clin Oncol. 2010 Jan 10;28(2):e15-6; author reply e17-8 [19949007.001]
  • [CommentIn] J Clin Oncol. 2009 Jun 20;27(18):2896-7 [19433677.001]
  • [ErratumIn] J Clin Oncol. 2009 Sep 20;27(27):4630. Dosage error in published abstract; MEDLINE/PubMed abstract corrected
  • (PMID = 19433686.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Recombinant Proteins; 0 / peginterferon alfa-2b; 30IQX730WE / Polyethylene Glycols; 99210-65-8 / interferon alfa-2b
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77. McDermott DF, Sosman JA, Gonzalez R, Hodi FS, Linette GP, Richards J, Jakub JW, Beeram M, Tarantolo S, Agarwala S, Frenette G, Puzanov I, Cranmer L, Lewis K, Kirkwood J, White JM, Xia C, Patel K, Hersh E: Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group. J Clin Oncol; 2008 May 1;26(13):2178-85
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  • [Title] Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group.
  • PURPOSE: This phase II study evaluated the efficacy and safety of sorafenib plus dacarbazine in patients with advanced melanoma.
  • PATIENTS AND METHODS: This randomized, double-blind, placebo-controlled, multicenter study enrolled chemotherapy-naive patients with stage III (unresectable) or IV melanoma.
  • On day 1 of a 21-day cycle, patients received intravenous dacarbazine 1,000 mg/m(2) for a maximum of 16 cycles.
  • The primary end point was progression-free survival (PFS) by independent assessment.
  • Secondary and tertiary end points included time to progression (TTP), response rate, and overall survival (OS).
  • RESULTS: Median PFS in the sorafenib plus dacarbazine arm was 21.1 weeks versus 11.7 weeks in the placebo plus dacarbazine arm (hazard ratio [HR], 0.665; P = .068).
  • There were statistically significant improvements in PFS rates at 6 and 9 months, and in TTP (median, 21.1 v 11.7 weeks; HR, 0.619) in favor of the sorafenib plus dacarbazine arm.
  • No difference in OS was observed (median, 51.3 v 45.6 weeks in the placebo plus dacarbazine and sorafenib plus dacarbazine arms, respectively; HR, 1.022).
  • CONCLUSION: Sorafenib plus dacarbazine was well tolerated in patients with advanced melanoma and yielded an encouraging improvement in PFS.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy
  • [MeSH-minor] Administration, Oral. Aged. Antineoplastic Agents, Alkylating / administration & dosage. Benzenesulfonates / administration & dosage. Dacarbazine / administration & dosage. Disease-Free Survival. Double-Blind Method. Female. Humans. Infusions, Intravenous. Kaplan-Meier Estimate. Male. Middle Aged. Neoplasm Staging. Niacinamide / analogs & derivatives. Phenylurea Compounds. Protein Kinase Inhibitors / administration & dosage. Pyridines / administration & dosage. Time Factors. Treatment Outcome. United States

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  • (PMID = 18445842.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; 0 / Benzenesulfonates; 0 / Phenylurea Compounds; 0 / Protein Kinase Inhibitors; 0 / Pyridines; 25X51I8RD4 / Niacinamide; 7GR28W0FJI / Dacarbazine; 9ZOQ3TZI87 / sorafenib
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78. Zimpfer-Rechner C, Hofmann U, Figl R, Becker JC, Trefzer U, Keller I, Hauschild A, Schadendorf D: Randomized phase II study of weekly paclitaxel versus paclitaxel and carboplatin as second-line therapy in disseminated melanoma: a multicentre trial of the Dermatologic Co-operative Oncology Group (DeCOG). Melanoma Res; 2003 Oct;13(5):531-6
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  • [Title] Randomized phase II study of weekly paclitaxel versus paclitaxel and carboplatin as second-line therapy in disseminated melanoma: a multicentre trial of the Dermatologic Co-operative Oncology Group (DeCOG).
  • Stage melanoma IV has a poor prognosis, with a median survival time between 3 and 11 months from the diagnosis of distant metastases.
  • Response rates in first-line regimens are around 20%.
  • To date, no second-line treatment has been established.
  • In arm A, paclitaxel was administered at a dose of 100 mg/m2 intravenously on day 1 each week for 6 weeks.
  • In arm B, paclitaxel was administered at a dose of 80 mg/m2 intravenously followed by carboplatin 200 mg/m2 on day 1 each week for 6 weeks.
  • The response rate, survival time, time-to-progression and toxicity were assessed in both arms.
  • The study was stopped after 40 patients because the overall response rate was below 10% in both arms.
  • The median survival time after initiation of second-line treatment was 209 days (+/- 196 days) for patients treated with paclitaxel only, and 218 days for those treated with paclitaxel/carboplatin.
  • The median time-to-progression was around 56 days in both arms.
  • Two partial responses were observed after 16 weeks, lasting for 8 and 12 weeks, respectively.
  • Although both treatment modalities were well tolerated, haematological toxicity was higher in the combination arm.
  • This is so far the largest second-line clinical phase II study reported in melanoma.
  • However, paclitaxel with or without carboplatin had only limited efficacy, and the combination of these drugs adds significantly to haematological toxicity without improving response or survival rates.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carboplatin / administration & dosage. Melanoma / drug therapy. Paclitaxel / administration & dosage
  • [MeSH-minor] Disease Progression. Female. Humans. Male. Time Factors. Treatment Outcome

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  • (PMID = 14512795.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] BG3F62OND5 / Carboplatin; P88XT4IS4D / Paclitaxel
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79. Ranson M, Hersey P, Thompson D, Beith J, McArthur GA, Haydon A, Davis ID, Kefford RF, Mortimer P, Harris PA, Baka S, Seebaran A, Sabharwal A, Watson AJ, Margison GP, Middleton MR: Randomized trial of the combination of lomeguatrib and temozolomide compared with temozolomide alone in chemotherapy naive patients with metastatic cutaneous melanoma. J Clin Oncol; 2007 Jun 20;25(18):2540-5
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  • [Title] Randomized trial of the combination of lomeguatrib and temozolomide compared with temozolomide alone in chemotherapy naive patients with metastatic cutaneous melanoma.
  • PURPOSE: To evaluate tumor response, pharmacodynamic effects, and safety of a combination of lomeguatrib (LM), an O6-methylguanine DNA-methyltransferase (MGMT) inactivator, and temozolomide (TMZ), TMZ alone, and LM/TMZ after disease progression on TMZ alone in patients with advanced melanoma.
  • PATIENTS AND METHODS: Patients with unresectable stage III or IV cutaneous melanoma who had no prior systemic chemotherapy were randomly assigned to receive either 40 to 80 mg LM and 125 mg/m2 TMZ or 200 mg/m2 TMZ on days 1 through 5 of each 28-day treatment cycle.
  • Drugs were administered orally for up to six cycles of treatment.
  • Patients on TMZ alone were offered LM/TMZ at progression, if fit enough to receive treatment.
  • RESULTS: One hundred four patients were enrolled, with 52 in each trial arm.
  • Tumor response rates were 13.5% with LM/TMZ and 17.3% with TMZ alone.
  • Median time to disease progression was 65.5 days for LM/TMZ and 68 days for TMZ.
  • All treatments were well tolerated, although hematologic and gastrointestinal adverse events were common.
  • A higher incidence of hematological adverse events was observed in the LM/TMZ combination arm.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Dacarbazine / analogs & derivatives. Enzyme Inhibitors / administration & dosage. Melanoma / drug therapy. O(6)-Methylguanine-DNA Methyltransferase / antagonists & inhibitors. Skin Neoplasms / drug therapy
  • [MeSH-minor] Administration, Oral. Adult. Aged. Aged, 80 and over. Disease Progression. Female. Humans. Male. Middle Aged. Neoplasm Staging. Purines. Treatment Outcome

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  • (PMID = 17577032.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Enzyme Inhibitors; 0 / Purines; 7GR28W0FJI / Dacarbazine; 85622-93-1 / temozolomide; EC 2.1.1.63 / O(6)-Methylguanine-DNA Methyltransferase; S79265T71M / lomeguatrib
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80. Ridolfi R, Tanganelli L, Scelzi E, Manente P, Palmeri S, Ravaioli A, Fiammenghi L, Romanini A, Italian Melaoma Intergroup: Chemotherapy and bio-chemotherapy in patients with advanced melanoma: combination therapy with a nitrosourea. J Chemother; 2003 Apr;15(2):198-202
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  • [Title] Chemotherapy and bio-chemotherapy in patients with advanced melanoma: combination therapy with a nitrosourea.
  • The treatment of advanced melanoma is still disappointing.
  • In a multicenter randomized clinical trial to compare a chemotherapy (CT) with or without low doses of IL-2 and IFN (Bio-CT), the participating centers chose whether or not to add a nitrosourea, carmustine (BCNU) to the therapy.
  • The aim of the present paper is to report the clinical results of the patients (pts) treated in both arms with BCNU.
  • One hundred and seventy-six pts with advanced melanoma were enrolled in the study from 27 centers and a total of 18 pts also received BCNU in 3 centers.
  • No further changes to the protocol criteria were allowed.
  • One patient refused the treatment.
  • No complete responses were observed.
  • Irrespectively of the treatment arm, 9/17 pts showed a partial response to therapy (53%) (5/9 in the CT and 4/8 in the BioCT arm).
  • The most important adverse events observed were hematological: 12 pts presented grade 3 (6 pts) or grade 4 (6 pts) leukocytopenia and 9 pts had grade 4 thrombocytopenia, all of which resolved spontaneously.
  • The addition of a nitrosourea to CT or Bio-CT appears to improve response rates compared to the same regimens without nitrosourea.
  • [MeSH-major] Antineoplastic Agents / pharmacology. Antineoplastic Agents, Alkylating / pharmacology. Carmustine / pharmacology. Interferon-alpha / pharmacology. Interleukin-2 / pharmacology. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Combined Modality Therapy. Female. Humans. Male. Middle Aged. Survival Analysis. Treatment Outcome

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  • (PMID = 12797399.001).
  • [ISSN] 1120-009X
  • [Journal-full-title] Journal of chemotherapy (Florence, Italy)
  • [ISO-abbreviation] J Chemother
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Antineoplastic Agents, Alkylating; 0 / Interferon-alpha; 0 / Interleukin-2; U68WG3173Y / Carmustine
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81. Siller G, Gebauer K, Welburn P, Katsamas J, Ogbourne SM: PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study. Australas J Dermatol; 2009 Feb;50(1):16-22
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  • [Title] PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study.
  • The sap of the plant Euphorbia peplus is a traditional remedy for skin conditions, including actinic keratosis.
  • Five preselected lesions were treated with ingenol mebutate gel, 0.0025%, 0.01% or 0.05%, or vehicle gel, on days 1 and 2 (Arm A) or days 1 and 8 (Arm B).
  • There were no significant differences in tolerability or efficacy between Arms A and B.
  • Treatment was well tolerated.
  • The most common local skin responses were dose-related erythema, flaking/scaling/dryness and scabbing/crusting.
  • Ingenol mebutate gel is being developed as a short-course topical therapy for actinic keratosis and non-melanoma skin cancer.
  • [MeSH-major] Antineoplastic Agents, Phytogenic / therapeutic use. Diterpenes / therapeutic use. Esters / therapeutic use. Keratosis, Actinic / drug therapy
  • [MeSH-minor] Administration, Cutaneous. Adult. Aged. Aged, 80 and over. Arm / pathology. Australia. Double-Blind Method. Drug Administration Schedule. Face / pathology. Female. Gels / therapeutic use. Humans. Male. Middle Aged. Scalp / pathology. Treatment Outcome

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  • (PMID = 19178487.001).
  • [ISSN] 1440-0960
  • [Journal-full-title] The Australasian journal of dermatology
  • [ISO-abbreviation] Australas. J. Dermatol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Australia
  • [Chemical-registry-number] 0 / 3-ingenyl angelate; 0 / Antineoplastic Agents, Phytogenic; 0 / Diterpenes; 0 / Esters; 0 / Gels
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82. Bedikian AY, Plager C, Stewart JR, O'Brian CA, Herdman SK, Ross M, Papadopoulos N, Eton O, Ellerhorst J, Smith T: Phase II evaluation of bryostatin-1 in metastatic melanoma. Melanoma Res; 2001 Apr;11(2):183-8
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  • [Title] Phase II evaluation of bryostatin-1 in metastatic melanoma.
  • In this phase II study we assessed the efficacy of bryostatin-1 (NSC 339555) in metastatic melanoma patients when given intravenously either once a week at a dose of 25 microg/m2 per day over 24 h for 3 weeks or at 40 microg/m2 per day over 72 h every 2 weeks.
  • Treatment courses were repeated every 4 weeks.
  • Patients who had received one prior chemotherapy regimen for advanced melanoma, with or without biotherapy, were randomized to one or the other bryostatin-1 dose schedules until 12 patients were registered to each arm.
  • Because there was one confirmed response among the 12 patients who received the 72 h dose schedule, 25 more patients were added to that arm.
  • No prophylactic medications were given.
  • The National Cancer Institutes common toxicity criteria were used to grade reactions.
  • In total, 49 patients with metastatic melanoma, none having symptomatic brain metastasis, were studied.
  • One patient receiving the 72 h regimen had a partial response lasting over 7 months.
  • There was no therapy-related thrombocytopenia.
  • Bryostatin-1 has limited activity against melanoma when given by 72 h intravenous infusion.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Lactones / therapeutic use. Melanoma / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Blotting, Western. Bryostatins. Dose-Response Relationship, Drug. Down-Regulation. Female. Humans. Macrolides. Male. Middle Aged. Neoplasm Metastasis. Protein Isoforms. Protein Kinase C / biosynthesis. Protein Kinase C / metabolism. Time Factors

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  • (PMID = 11333129.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Bryostatins; 0 / Lactones; 0 / Macrolides; 0 / Protein Isoforms; 37O2X55Y9E / bryostatin 1; EC 2.7.11.13 / Protein Kinase C
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83. Maki RG, D'Adamo DR, Keohan ML, Saulle M, Schuetze SM, Undevia SD, Livingston MB, Cooney MM, Hensley ML, Mita MM, Takimoto CH, Kraft AS, Elias AD, Brockstein B, Blachère NE, Edgar MA, Schwartz LH, Qin LX, Antonescu CR, Schwartz GK: Phase II study of sorafenib in patients with metastatic or recurrent sarcomas. J Clin Oncol; 2009 Jul 01;27(19):3133-40
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  • PATIENTS AND METHODS We employed a multiarm study design, each representing a sarcoma subtype with its own Simon optimal two-stage design.
  • In each arm, 12 patients who received 0 to 1 prior lines of therapy were treated (0 to 3 for angiosarcoma and malignant peripheral-nerve sheath tumor).
  • If at least one Response Evaluation Criteria in Solid Tumors (RECIST) was observed, 25 further patients with that sarcoma subtype were accrued.
  • Results Between October 2005 and November 2007, 145 patients were treated; 144 were eligible for toxicity and 122 for response.
  • Median age was 55 years; female-male ratio was 1.8:1.
  • Five of 37 patients with angiosarcoma had a partial response (response rate, 14%).
  • This was the only arm to meet the RECIST response rate primary end point.
  • Median progression-free survival was 3.2 months; median overall survival was 14.3 months.
  • There was no correlation between phosphorylated extracellular signal regulated kinase expression and response in six patients with angiosarcoma with paired pre- and post-therapy biopsies.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Benzenesulfonates / therapeutic use. Neoplasm Recurrence, Local / drug therapy. Pyridines / therapeutic use. Sarcoma / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Disease-Free Survival. Female. Humans. Kaplan-Meier Estimate. Male. Middle Aged. Niacinamide / analogs & derivatives. Phenylurea Compounds. Young Adult

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  • (PMID = 19451436.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / N01CM62202; United States / NCI NIH HHS / CA / P01 CA047179
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Benzenesulfonates; 0 / Phenylurea Compounds; 0 / Pyridines; 25X51I8RD4 / Niacinamide; 9ZOQ3TZI87 / sorafenib
  • [Other-IDs] NLM/ PMC2716936
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84. Schadendorf D, Algarra SM, Bastholt L, Cinat G, Dreno B, Eggermont AM, Espinosa E, Guo J, Hauschild A, Petrella T, Schachter J, Hersey P: Immunotherapy of distant metastatic disease. Ann Oncol; 2009 Aug;20 Suppl 6:vi41-50
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  • [Title] Immunotherapy of distant metastatic disease.
  • Immunotherapy of metastatic melanoma consists of various approaches leading to specific or non-specific immunomodulation.
  • Many studies with allogeneic and autologous vaccines have demonstrated no clinical benefit, and some randomised trials even showed a detrimental effect in the vaccine arm.
  • The ongoing effort to develop melanoma vaccines based on dendritic cells and peptides is driven by advances in understanding antigen presentation and processing, and by new techniques of vaccine preparation, stabilisation and delivery.
  • Several agents that have shown promising activity in metastatic melanoma including IL-21 and monoclonal antibodies targeting cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) or CD137 are discussed.
  • Recent advances of intratumour gene transfer technologies and adoptive immunotherapy, which represents a promising although technically challenging direction, are also discussed.

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  • (PMID = 19617297.001).
  • [ISSN] 1569-8041
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Cancer Vaccines
  • [Number-of-references] 101
  • [Other-IDs] NLM/ PMC2712591
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85. Camacho LH, Antonia S, Sosman J, Kirkwood JM, Gajewski TF, Redman B, Pavlov D, Bulanhagui C, Bozon VA, Gomez-Navarro J, Ribas A: Phase I/II trial of tremelimumab in patients with metastatic melanoma. J Clin Oncol; 2009 Mar 1;27(7):1075-81
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  • [Title] Phase I/II trial of tremelimumab in patients with metastatic melanoma.
  • PATIENTS AND METHODS: Twenty-eight patients with metastatic melanoma received monthly intravenous infusions of tremelimumab at 3, 6, or 10 mg/kg for up to 1 year to determine recommended monthly phase II dose.
  • In phase II, 8 (10%) of 84 response-assessable patients attained objective antitumor responses; best overall objective response was one complete response and three partial responses in each dosing regimen.
  • Most responses were durable (range, 3 to 30+ months).
  • Most frequent treatment-related adverse events (AEs) were diarrhea, rash, and pruritus.
  • Frequency of grade 3/4 AEs was 13% in the 15 mg/kg every 3 months arm and 27% in the 10 mg/kg once every month.
  • Serious AEs were also less frequent in the 15 mg/kg once every 3 months cohort (9% v 23% in 10 mg/kg arm).
  • Both phase II regimens generated durable tumor responses.

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  • (PMID = 19139427.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / K24 CA128953; United States / NCI NIH HHS / CA / CA 27469; United States / NCI NIH HHS / CA / CA 37517; United States / NCI NIH HHS / CA / CA 87558
  • [Publication-type] Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antineoplastic Agents; QEN1X95CIX / tremelimumab
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86. Eggermont AM, Testori A, Marsden J, Hersey P, Quirt I, Petrella T, Gogas H, MacKie RM, Hauschild A: Utility of adjuvant systemic therapy in melanoma. Ann Oncol; 2009 Aug;20 Suppl 6:vi30-4
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  • [Title] Utility of adjuvant systemic therapy in melanoma.
  • The lack of effective drugs in stage IV melanoma has impacted the effectiveness of adjuvant therapies in stage II/III disease.
  • To date, chemotherapy, immunostimulants and vaccines have been used with minimal success.
  • Interferon (IFN) has shown an effect on relapse-free survival (RFS) in several clinical trials; however, without a clinically significant effect on overall survival (OS).
  • A recently conducted meta-analysis demonstrated prolongation of disease-free survival (DFS) in 7% and OS benefit in 3% of IFN-treated patients when compared with observation-only patients.
  • There were no clear differences for the dose and duration of treatment observed.
  • Observation is still an appropriate control arm in adjuvant clinical trials.
  • In Central and Mediterranean Europe, dermatologists commonly prescribe low-dose IFN therapy for AJCC stage II and III disease.
  • The population of patients that may benefit from IFN needs to be further characterised, potentially by finding biomarkers that can predict response.

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  • (PMID = 19617295.001).
  • [ISSN] 1569-8041
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents
  • [Number-of-references] 32
  • [Other-IDs] NLM/ PMC2712588
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87. Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, Patel K, Kirkwood JM, Keilholz U: Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol; 2009 Jun 10;27(17):2823-30
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  • [Title] Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma.
  • PURPOSE: This phase III, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of sorafenib with carboplatin and paclitaxel (CP) in patients with advanced melanoma who had progressed on a dacarbazine- or temozolomide-containing regimen.
  • PATIENTS AND METHODS: A total of 270 patients were randomly assigned to receive intravenous paclitaxel 225 mg/m2 plus intravenous carboplatin at area under curve 6 (AUC 6) on day 1 of a 21-day cycle followed by either placebo (n = 135) or oral sorafenib 400 mg (n = 135) twice daily on days 2 to 19.
  • The primary efficacy end point was progression-free survival (PFS); secondary and tertiary end points included overall survival and incidence of best response, respectively.
  • RESULTS: The median PFS was 17.9 weeks for the placebo plus CP arm and 17.4 weeks for the sorafenib plus CP arm (hazard ratio, 0.91; 99% CI, 0.63 to 1.31; two-sided log-rank test P = .49).
  • Response rate was 11% with placebo versus 12% with sorafenib.
  • CONCLUSION: In this study, the addition of sorafenib to CP did not improve any of the end points over placebo plus CP and cannot be recommended in the second-line setting for patients with advanced melanoma.
  • A trial of similar design for the first-line treatment of patients with advanced melanoma (intergroup trial E2603) is currently ongoing.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Neoplasm Staging
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Carboplatin / therapeutic use. Double-Blind Method. Female. Humans. Male. Middle Aged. Paclitaxel / therapeutic use. Placebos. Treatment Outcome. Young Adult

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  • (PMID = 19349552.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Placebos; BG3F62OND5 / Carboplatin; P88XT4IS4D / Paclitaxel
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88. Kleeberg UR, Suciu S, Bröcker EB, Ruiter DJ, Chartier C, Liénard D, Marsden J, Schadendorf D, Eggermont AM, EORTC Melanoma Group in cooperation with the German Cancer Society (DKG): Final results of the EORTC 18871/DKG 80-1 randomised phase III trial. rIFN-alpha2b versus rIFN-gamma versus ISCADOR M versus observation after surgery in melanoma patients with either high-risk primary (thickness &gt;3 mm) or regional lymph node metastasis. Eur J Cancer; 2004 Feb;40(3):390-402
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  • [Title] Final results of the EORTC 18871/DKG 80-1 randomised phase III trial. rIFN-alpha2b versus rIFN-gamma versus ISCADOR M versus observation after surgery in melanoma patients with either high-risk primary (thickness >3 mm) or regional lymph node metastasis.
  • Between 1988 and 1996, the European Organisation for Research and Treatment of Cancer Melanoma Group (EORTC-MG) performed a prospective, randomised phase III adjuvant trial to evaluate the efficacy and toxicity of low dose recombinant interferon-alpha 2 b (rIFN-alpha2b) (1 MU) or recombinant interferon gamma (rIFN-gamma), (0.2 mg) both given subcutaneously (s.c.
  • The German Cancer Society (DKG) added a fourth arm with Iscador M, a popular mistletoe extract.
  • High-risk stage II patients (thickness >3 mm) and stage III patients (positive lymph nodes) without distant metastasis were randomised and followed until their first progression or death.
  • From 1988 to 1996, a total of 830 patients were randomised: 423 in the three-arm EORTC 18871 trial and 407 patients in the four-arm DKG 80-1 trial.
  • The median follow-up was 8.2 years and a total of 537 relapses and 475 deaths were reported.
  • At 8 years, the disease-free interval (DFI) rate was 32.4% and the overall survival (OS) rate was 40.0%.
  • In terms of the DFI, the hazard ratio estimates (95% Confidence Intervals (CI)) were: 1.04 (0.84, 1.30) for the comparison of rIFN-alpha2b versus control, 0.96 (0.77, 1.20) for rIFN-gamma versus control, and 1.32 (0.93, 1.87) for Iscador M versus control.
  • In terms of OS, the corresponding estimates (95% CI) for the 3 treatment comparisons were: for IFN-alpha2b 0.96 (0.76, 1.21), for rIFN-gamma 0.87 (0.69, 1.10) and for Iscador M 1.21 (0.84, 1.75), respectively.
  • The results show no clinical benefit for adjuvant treatment with low dose rIFN-alpha2b or rIFN-gamma or with Iscador M in high-risk melanoma patients.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Interferon-alpha / therapeutic use. Interferon-gamma / therapeutic use. Melanoma / drug therapy. Plant Extracts / therapeutic use. Plant Proteins / therapeutic use. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Disease-Free Survival. Feasibility Studies. Female. Humans. Lymphatic Metastasis. Male. Middle Aged. Recombinant Proteins. Risk Factors. Treatment Outcome

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  • (PMID = 14746858.001).
  • [ISSN] 0959-8049
  • [Journal-full-title] European journal of cancer (Oxford, England : 1990)
  • [ISO-abbreviation] Eur. J. Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / 3U10-CA11488-18S1; United States / NCI NIH HHS / CA / 5U10-CA11488-33
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Plant Extracts; 0 / Plant Proteins; 0 / Recombinant Proteins; 0 / viscum album peptide; 82115-62-6 / Interferon-gamma; 99210-65-8 / interferon alfa-2b
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89. Bouwhuis MG, Suciu S, Testori A, Kruit WH, Salès F, Patel P, Punt CJ, Santinami M, Spatz A, Ten Hagen TL, Eggermont AM: Phase III trial comparing adjuvant treatment with pegylated interferon Alfa-2b versus observation: prognostic significance of autoantibodies--EORTC 18991. J Clin Oncol; 2010 May 10;28(14):2460-6
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  • [Title] Phase III trial comparing adjuvant treatment with pegylated interferon Alfa-2b versus observation: prognostic significance of autoantibodies--EORTC 18991.
  • PURPOSE: Conflicting data have been reported concerning the prognostic value of autoimmune antibodies in patients with melanoma treated with adjuvant interferon alfa-2b (IFN).
  • We evaluated the prognostic significance of autoantibodies in the European Organisation for Research and Treatment of Cancer 18991 trial, comparing long-term administration of pegylated IFN (PEG-IFN) with observation.
  • Prognostic impact of autoantibodies on recurrence-free survival (RFS) was assessed using the following three Cox models: a model that considered autoantibody appearance as a time-independent variable (model 1); a model that considered a patient to be autoantibody positive from the first positive test (model 2); and a model in which the most recent autoantibody test was used to define the status of the patient (model 3).
  • Occurrence of autoantibodies during follow-up was higher in the PEG-IFN-treated patients (18% in the observation arm v 52% in the PEG-IFN arm).
  • Autoantibody appearance was of prognostic importance by using model 1 (hazard ratio [HR] = 0.56; 95% CI, 0.36 to 0.87; P = .01).
  • However, when guarantee-time bias was taken into account using model 2 (HR = 1.19; 95% CI, 0.75 to 1.88; P = .46) or method 3 (HR = 1.14; 95% CI, 0.71 to 1.83; P = .59), significance was lost.
  • Results were similar when treatment groups were analyzed separately.
  • CONCLUSION: Appearance of autoimmune antibodies is neither a prognostic nor a predictive factor for improved outcome in patients with melanoma treated with PEG-IFN.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Autoantibodies / blood. Interferon-alpha / therapeutic use. Melanoma / drug therapy. Polyethylene Glycols / therapeutic use. Skin Neoplasms / drug therapy
  • [MeSH-minor] Aged. Antibodies, Anticardiolipin / blood. Antibodies, Antinuclear / blood. Chemotherapy, Adjuvant. Disease-Free Survival. Drug Administration Schedule. Female. Humans. Injections, Subcutaneous. Kaplan-Meier Estimate. Lymph Node Excision. Male. Middle Aged. Neoplasm Staging. Proportional Hazards Models. Recombinant Proteins. Risk Assessment. Risk Factors. Time Factors. Treatment Outcome

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  • (PMID = 20385998.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Anticardiolipin; 0 / Antibodies, Antinuclear; 0 / Antineoplastic Agents; 0 / Autoantibodies; 0 / Interferon-alpha; 0 / Recombinant Proteins; 0 / anti-thyroglobulin; 0 / peginterferon alfa-2b; 30IQX730WE / Polyethylene Glycols; 99210-65-8 / interferon alfa-2b
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90. Keilholz U, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, Thomas J, Proebstle TM, Schmittel A, Schadendorf D, Velu T, Negrier S, Kleeberg U, Lehman F, Suciu S, Eggermont AM: Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol; 2005 Sep 20;23(27):6747-55
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  • [Title] Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group.
  • BACKGROUND: Based on phase II trial results, chemoimmunotherapy combinations have become the preferred treatment for patients with metastatic melanoma in many institutions.
  • This study was performed to determine whether interleukin-2 (IL-2) as a component of chemoimmunotherapy influences survival of patients with metastatic melanoma.
  • PATIENTS AND METHODS: Patients with advanced metastatic melanoma were randomly assigned to receive dacarbazine 250 mg/m2 and cisplatin 30 mg/m2 on days 1 to 3 combined with interferon-alfa-2b 10 x 10(6) U/m2 subcutaneously on days 1 through 5 without (arm A) or with (arm B) a high-dose intravenous decrescendo regimen of IL-2 on days 5 through 10 (18 x 10(6) U/m2/6 hours, 18 x 10(6) U/m2/12 hours, 18 x 10(6) U/m2/24 hours, and 4.5 x 10(6) U/m2 for 3 x 24 hours).
  • Treatment cycles were repeated in the absence of disease progression every 28 days to a maximum of four cycles.
  • RESULTS: Three hundred sixty-three patients with advanced metastatic melanoma were accrued.
  • The median survival was 9 months in both arms, with a 2-year survival rate of 12.9% and 17.6% in arms A and B, respectively (P = .32; hazard ratio, 0.90; 95% CI, 0.72 to 1.11).
  • There was also no statistically significant difference regarding progression-free survival (median, 3.0 v 3.9 months) and response rate (22.8% v 20.8%).
  • CONCLUSION: Despite its activity in melanoma as a single agent or in combination with interferon-alfa-2b, the chosen schedule of IL-2 added to the chemoimmunotherapy combination had no clinically relevant activity.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Melanoma / mortality. Skin Neoplasms / drug therapy. Skin Neoplasms / mortality. Skin Neoplasms / pathology
  • [MeSH-minor] Adult. Aged. Biopsy, Needle. Cisplatin / therapeutic use. Dacarbazine / therapeutic use. Dose-Response Relationship, Drug. Drug Administration Schedule. Europe. Female. Follow-Up Studies. Humans. Immunohistochemistry. Interferon-alpha / therapeutic use. Interleukin-2 / therapeutic use. Male. Maximum Tolerated Dose. Middle Aged. Neoplasm Metastasis. Neoplasm Staging. Probability. Proportional Hazards Models. Recombinant Proteins. Reference Values. Survival Rate. Treatment Outcome

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  • (PMID = 16170182.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / 2U10 CA11488-25; United States / NCI NIH HHS / CA / 5U10 CA11488-32
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Interleukin-2; 0 / Recombinant Proteins; 7GR28W0FJI / Dacarbazine; 99210-65-8 / interferon alfa-2b; Q20Q21Q62J / Cisplatin
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91. Glover D, Ibrahim J, Kirkwood J, Glick J, Karp D, Stewart J, Ewell M, Borden E, Eastern Cooperative Oncology Group: Phase II randomized trial of cisplatin and WR-2721 versus cisplatin alone for metastatic melanoma: an Eastern Cooperative Oncology Group Study (E1686). Melanoma Res; 2003 Dec;13(6):619-26
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II randomized trial of cisplatin and WR-2721 versus cisplatin alone for metastatic melanoma: an Eastern Cooperative Oncology Group Study (E1686).
  • This study was designed to evaluate the toxicity and efficacy of cisplatin and WR-2721 in contrast to cisplatin alone for the therapy of measurable metastatic melanoma.
  • Ninety-four patients with metastatic melanoma were randomized to receive either cisplatin at a dose of 150 mg/m2 and WR-2721 at a dose of 910 mg/m2, or cisplatin alone at a dose of 120 mg/m2.
  • WR-2721 did not mitigate the toxic effects of cisplatin, and toxicity was increased in the WR-2721 plus cisplatin arm compared with cisplatin alone.
  • For patients receiving cisplatin alone, the response rate was 16.3%; for those receiving cisplatin plus WR-2721, the response rate was 23.3%.
  • The duration of response was 7.3 months.
  • The study was terminated after accrual of 94 patients, with inadequate power to define an effect of WR-2721 on the duration of response and survival.
  • In conclusion, cisplatin with WR-2721 showed an improved response rate over cisplatin alone.
  • The lack of improved duration of response or impact on survival may be the result of the limited improvement of efficacy with the higher dosage of cisplatin in conjunction with WR-2721, or the limited number of patients accrued to this study.
  • [MeSH-major] Amifostine / administration & dosage. Cisplatin / administration & dosage. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Antineoplastic Combined Chemotherapy Protocols. Blood Pressure. Body Weight. Female. Humans. Hypotension. Male. Middle Aged. Neoplasm Metastasis. Radiation-Protective Agents / administration & dosage. Time Factors. Treatment Outcome

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  • (PMID = 14646626.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA07190; United States / NCI NIH HHS / CA / CA15488; United States / NCI NIH HHS / CA / CA18653; United States / NCI NIH HHS / CA / CA21076; United States / NCI NIH HHS / CA / CA21115; United States / NCI NIH HHS / CA / CA23318; United States / NCI NIH HHS / CA / CA66636
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Radiation-Protective Agents; M487QF2F4V / Amifostine; Q20Q21Q62J / Cisplatin
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92. Ridolfi R, Chiarion-Sileni V, Guida M, Romanini A, Labianca R, Freschi A, Lo Re G, Nortilli R, Brugnara S, Vitali P, Nanni O, Italian Melanoma Intergroup: Cisplatin, dacarbazine with or without subcutaneous interleukin-2, and interferon alpha-2b in advanced melanoma outpatients: results from an Italian multicenter phase III randomized clinical trial. J Clin Oncol; 2002 Mar 15;20(6):1600-7
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cisplatin, dacarbazine with or without subcutaneous interleukin-2, and interferon alpha-2b in advanced melanoma outpatients: results from an Italian multicenter phase III randomized clinical trial.
  • PURPOSE: Phase II and III studies have shown that the addition of interleukin-2 (IL-2) and interferon alpha-2b (IFN alpha-2b) in multiagent chemotherapy (CT) for advanced melanoma increases overall response (OR), albeit without clear evidence of an improvement in overall survival (OS).
  • Treatment with high-dose IL-2 can cause severe toxicity and is normally administered in an inpatient setting.
  • We conducted a multicenter prospective randomized clinical trial in outpatients with metastatic melanoma to compare CT with biochemotherapy (bioCT) using immunomodulant doses of IL-2 and IFN alpha-2b.
  • PATIENTS AND METHODS: One hundred seventy-six eligible patients with advanced melanoma were randomized to receive CT (cisplatin and dacarbazine with or without carmustine every 21 days) or bioCT comprising the same CT regimen followed by low-dose subcutaneous IL-2 for 8 days and IFN alpha-2b three times a week, both for six cycles.
  • RESULTS: At a median follow-up of 18 (CT) and 16 (bioCT) months, median OS was 9.5 versus 11.0 months (P =.51), respectively.
  • In the 89 CT-arm patients, 18 ORs (20.2%) (three complete responders [CRs] and 15 partial responders [PRs]) were observed according to World Health Organization criteria.
  • In the 87 bioCT-arm patients, 22 ORs (25.3%) (three CRs and 19 PRs) (P =.70) were recorded.
  • Treatment-related toxicity was fairly similar in both arms.
  • CONCLUSION: The addition of low-dose immunotherapy did not produce a statistically significant advantage in OS, time to progression, or OR.
  • However, the 11-month median OS in the bioCT arm does not differ greatly from the best results with high-dose IL-2-containing regimens reported in the literature.
  • Furthermore, our treatment schedule was carried out on outpatients and had an acceptable level of toxicity.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Carmustine / administration & dosage. Cisplatin / administration & dosage. Dacarbazine / administration & dosage. Female. Humans. Interferon-alpha / administration & dosage. Interleukin-2 / administration & dosage. Italy. Male. Middle Aged. Outpatients. Proportional Hazards Models. Prospective Studies. Quality of Life. Recombinant Proteins. Surveys and Questionnaires. Treatment Outcome

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  • [CommentIn] J Clin Oncol. 2002 Aug 15;20(16):3560; author reply 3560-1 [12177119.001]
  • (PMID = 11896110.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Interleukin-2; 0 / Recombinant Proteins; 43K1W2T1M6 / interferon alfa-2b; 7GR28W0FJI / Dacarbazine; Q20Q21Q62J / Cisplatin; U68WG3173Y / Carmustine
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93. Eager RM, Cunningham CC, Senzer NN, Stephenson J Jr, Anthony SP, O'Day SJ, Frenette G, Pavlick AC, Jones B, Uprichard M, Nemunaitis J: Phase II assessment of talabostat and cisplatin in second-line stage IV melanoma. BMC Cancer; 2009;9:263
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II assessment of talabostat and cisplatin in second-line stage IV melanoma.
  • BACKGROUND: Metastatic melanoma is an incurable disease with an average survival of less than one year.
  • METHODS: This phase II, open label, single arm study was conducted to evaluate the safety and efficacy of 75-100 mg/m2 cisplatin combined with 300-400 mcg talabostat bid for 6, 21-day cycles.
  • The primary endpoint was overall response.
  • The rate of complete responses, duration of overall objective response, progression-free survival (PFS), and overall survival were the secondary endpoints.
  • RESULTS: Six objective partial responses were recorded in the 74 patients (8.1%) in the intention-to-treat population.
  • Five of these responses involved the 40 evaluable patients (12.5%).
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Boronic Acids / administration & dosage. Cisplatin / administration & dosage. Dipeptides / administration & dosage. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Disease Progression. Disease-Free Survival. Female. Humans. Male. Middle Aged. Prognosis. Treatment Outcome

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  • (PMID = 19643020.001).
  • [ISSN] 1471-2407
  • [Journal-full-title] BMC cancer
  • [ISO-abbreviation] BMC Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Boronic Acids; 0 / Dipeptides; KZ1O2SH88Z / talabostat; Q20Q21Q62J / Cisplatin
  • [Other-IDs] NLM/ PMC2731782
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94. Stewart AK, Bland KI, McGinnis LS Jr, Morrow M, Eyre HJ: Clinical highlights from the National Cancer Data Base, 2000. CA Cancer J Clin; 2000 May-Jun;50(3):171-83

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Clinical highlights from the National Cancer Data Base, 2000.
  • The National Cancer Data Base (NCDB) is the empirical data collection and analysis arm of the American College of Surgeons Commission on Cancer, and is supported in part by the American Cancer Society.
  • The NCDB collects oncology patient demographic information, diagnostic and treatment information, and outcomes data from a broad spectrum of hospital-based cancer registries throughout the US, ranging from large research and teaching facilities to small community hospitals.
  • Included among these are articles on breast cancer, gastric carcinoma, head and neck cancers, leukemia, liver carcinoma, lung cancer, parathyroid tumors, prostate carcinoma, small bowel adenocarcinoma, testicular malignancies, and vulvar melanoma.
  • The NCDB has accrued more than 6.4 million cancer cases for this time period.
  • Sufficient numbers of rare cancers are reported to the NCDB to permit some types of clinical evaluation not possible using other data sources.
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Carcinoma / epidemiology. Female. Head and Neck Neoplasms / epidemiology. Head and Neck Neoplasms / therapy. Humans. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Leukemia, Lymphocytic, Chronic, B-Cell / epidemiology. Liver Neoplasms / epidemiology. Liver Neoplasms / therapy. Lung Neoplasms / epidemiology. Lung Neoplasms / therapy. Male. Middle Aged. Parathyroid Neoplasms / epidemiology. Parathyroid Neoplasms / therapy. Stomach Neoplasms / epidemiology. Survival Rate. Testicular Neoplasms / epidemiology. Testicular Neoplasms / therapy. United States / epidemiology. Vulvar Neoplasms / epidemiology. Vulvar Neoplasms / therapy

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  • (PMID = 10901740.001).
  • [ISSN] 0007-9235
  • [Journal-full-title] CA: a cancer journal for clinicians
  • [ISO-abbreviation] CA Cancer J Clin
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] UNITED STATES
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95. Sabel MS, Sondak VK: Point: Interferon-alpha for adjuvant therapy for melanoma patients. J Natl Compr Canc Netw; 2004 Jan;2(1):61-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Point: Interferon-alpha for adjuvant therapy for melanoma patients.
  • Interferon-alpha is possibly the most controversial adjuvant therapy for any solid tumor, and multiple trials involving varying doses, routes, schedules, and formulations of interferon-alpha have increased the confusion.
  • Clinicians are left in a quandary, because high-dose interferon-alpha-2b (HDI) remains the only FDA-approved adjuvant therapy for high-risk melanoma.
  • Of the three prospective randomized trials involving high-dose interferon-alpha-2b, all show a significant improvement in disease-free survival and two show a significant improvement in overall survival.
  • Despite this strong evidence, data from studies involving alternate doses, concerns regarding cost and toxicity, and the promise of future therapies have led opponents of interferon to overlook these results.
  • Based on the available clinical evidence, however, high-dose interferon should be offered as standard care for patients with high-risk, resected melanoma.
  • Informed patients who have elected to forego interferon and patients with lower risk lesions can be offered participation in clinical trials with a no-treatment control arm.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Interferon-alpha / administration & dosage. Melanoma / drug therapy
  • [MeSH-minor] Chemotherapy, Adjuvant. Humans. Recombinant Proteins

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  • [CommentIn] J Natl Compr Canc Netw. 2004 Jan;2(1):1 [19777689.001]
  • (PMID = 19777695.001).
  • [ISSN] 1540-1405
  • [Journal-full-title] Journal of the National Comprehensive Cancer Network : JNCCN
  • [ISO-abbreviation] J Natl Compr Canc Netw
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 99210-65-8 / interferon alfa-2b
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96. Elias EG, Zapas JL, Beam SL, Brown SD: GM-CSF and IL-2 combination as adjuvant therapy in cutaneous melanoma: early results of a phase II clinical trial. Oncology (Williston Park); 2005 Apr;19(4 Suppl 2):15-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] GM-CSF and IL-2 combination as adjuvant therapy in cutaneous melanoma: early results of a phase II clinical trial.
  • Cytokines have been used in the treatment of patients with cutaneous melanoma.
  • In this open-label, single-arm study of 16 high-risk patients, we combined these two agents to take advantage of their different but complementary functions.
  • Postoperatively, each patient received GM-CSF at 125 microg/m2/d subcutaneously (SC) for 14 days; this was followed by IL-2 at 9 million IU/m2/d SC for 4 days, and then 10 to 12 days of no treatment.
  • In addition, patients who had large tumors that could yield over 100 million live tumor cells received autologous melanoma vaccines.
  • During follow-up, five patients developed metastases.
  • The combination treatment regimen of GM-CSF and IL-2 with or without autologous vaccine used adjuvantly appears to benefit high-risk melanoma patients; further clinical testing of this regimen is warranted.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Granulocyte-Macrophage Colony-Stimulating Factor / administration & dosage. Immunotherapy / methods. Interleukin-2 / administration & dosage. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Chemotherapy, Adjuvant. Female. Humans. Male. Middle Aged. Recombinant Proteins

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  • (PMID = 15934495.001).
  • [ISSN] 0890-9091
  • [Journal-full-title] Oncology (Williston Park, N.Y.)
  • [ISO-abbreviation] Oncology (Williston Park, N.Y.)
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interleukin-2; 0 / Recombinant Proteins; 123774-72-1 / sargramostim; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor
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97. Slingluff CL, Petroni GR, Smolkin ME, Chianese-Bullock KA, Smith K, Murphy C, Galeassi N, Neese PY, Grosh WW, Nail CJ, Ross M, von Mehren M, Haas N, Boisvert ME, Kirkwood JM: Immunogenicity for CD8+ and CD4+ T cells of 2 formulations of an incomplete freund's adjuvant for multipeptide melanoma vaccines. J Immunother; 2010 Jul-Aug;33(6):630-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Immunogenicity for CD8+ and CD4+ T cells of 2 formulations of an incomplete freund's adjuvant for multipeptide melanoma vaccines.
  • An incomplete Freund's adjuvant (IFA) commonly used in experimental cancer vaccines has recently been reformulated.
  • To provide an insight into the adjuvant properties of the new formulation, we reviewed T-cell responses, by enzyme-linked immunospot assay, to multipeptide vaccines in 2 sequential clinical trials that spanned this transition of adjuvants.
  • Analyses included 194 patients who received either IFA-AN or IFA-VG for all vaccines, and a subset of 93 patients best matched by study arm for vaccine antigens (12 melanoma peptides restricted by major histocompatibility complex class I, 12MP; plus a tetanus helper peptide, tet) administered with IFA but without granulocyte macrophage-colony stimulating factor.
  • CD8 T-cell response rates to the 12 melanoma peptides were 53% [95% confidence interval (CI), 44%, 61%)] for IFA-AN and 46% [95% CI, 32%, 59%)] for IFA-VG.
  • In the 93 patient subset, these rates were 73% [95% CI, 61%, 83%)] and 70% [95% CI, 47%, 87%)], respectively.
  • CD4 T-cell responses to tetanus helper peptide were identified in 94% [95% CI, 86%, 98%)] and 96% [95% CI, 78%, 100%)], respectively.
  • Responses to individual human leukocyte antigen (HLA)-A1, A2, and DR associated peptides were largely preserved, but reactivity trended lower for some HLA-A3 associated peptides.
  • Despite the necessarily retrospective nature of the analysis and limitations of multiple comparisons, our summary data support the use of IFA-VG as an adjuvant with multipeptide vaccines in melanoma patients.

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  • (PMID = 20551833.001).
  • [ISSN] 1537-4513
  • [Journal-full-title] Journal of immunotherapy (Hagerstown, Md. : 1997)
  • [ISO-abbreviation] J. Immunother.
  • [Language] ENG
  • [Grant] United States / NCATS NIH HHS / TR / UL1 TR000005; United States / NCI NIH HHS / CA / R01 CA118386-05; United States / NCI NIH HHS / CA / NIH R01 CA118386; United States / NCI NIH HHS / CA / R21 CA103528-01; United States / NCI NIH HHS / CA / P30 CA044579; United States / NCRR NIH HHS / RR / NIH M01 RR00847; United States / NCI NIH HHS / CA / R01 CA118386-02; United States / NCI NIH HHS / CA / R21 CA103528-02; United States / NCI NIH HHS / CA / P30 CA044579-18; United States / NCI NIH HHS / CA / R01 CA118386-03; United States / NCI NIH HHS / CA / NIH R21 CA103528; United States / NCI NIH HHS / CA / R01 CA118386; United States / NCI NIH HHS / CA / R21 CA103528; United States / NCI NIH HHS / CA / R01 CA118386-04; United States / NCI NIH HHS / CA / NIH/NCI P30 CA44579; United States / NCRR NIH HHS / RR / M01 RR000847
  • [Publication-type] Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Antigens, Neoplasm; 0 / Cancer Vaccines; 0 / Fats; 0 / Peptide Fragments; 0 / Vaccines, Subunit; 61789-97-7 / tallow; 9007-81-2 / Freund's Adjuvant
  • [Other-IDs] NLM/ NIHMS221635; NLM/ PMC3218563
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98. Eigentler TK, Radny P, Hauschild A, Gutzmer R, Linse R, Pföhler C, Wagner SN, Schadendorf D, Ellwanger U, Garbe C, German Dermatologic Cooperative Oncology Group: Adjuvant treatment with vindesine in comparison to observation alone in patients with metastasized melanoma after complete metastasectomy: a randomized multicenter trial of the German Dermatologic Cooperative Oncology Group. Melanoma Res; 2008 Oct;18(5):353-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Adjuvant treatment with vindesine in comparison to observation alone in patients with metastasized melanoma after complete metastasectomy: a randomized multicenter trial of the German Dermatologic Cooperative Oncology Group.
  • To evaluate the efficacy and safety of vindesine in patients with metastatic melanoma after complete metastasectomy.
  • One hundred and forty-two patients with metastatic spread to regional sites, lymph nodes, and distant sites after complete metastasectomy were randomized to receive either treatment with vindesine for 2 years or observation alone.
  • Median follow-up time was 46 months.
  • Median recurrence free survival was 7.9 months in the vindesine group and 7.6 months in the observational group (P=0.40).
  • Three-year overall survival rate was 54.9% (37 patients) for patients receiving vindesine in comparison to 43.6% (31 patients) in the observation arm (P=0.07).
  • Ten patients went off treatment because of grade III toxicity.
  • Adjuvant treatment with vindesine did not significantly prolong disease free or overall survival in high-risk melanoma patients.
  • [MeSH-major] Antineoplastic Agents, Phytogenic / therapeutic use. Melanoma / drug therapy. Melanoma / secondary. Vindesine / therapeutic use
  • [MeSH-minor] Adult. Chemotherapy, Adjuvant. Female. Humans. Lymph Node Excision. Lymphatic Metastasis. Male. Middle Aged. Skin Neoplasms / drug therapy. Skin Neoplasms / mortality. Survival Rate

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  • [CommentIn] Melanoma Res. 2009 Apr;19(2):123-4 [19289925.001]
  • (PMID = 18781134.001).
  • [ISSN] 1473-5636
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Phytogenic; RSA8KO39WH / Vindesine
  • [Investigator] Hermes B; Kohl P; Mohr P; Breitbart EW; Koch HJ; Schreiter K; Stein A; Sebastian G; Meurer M; Kellner I; Linse R; Wagner S; Goos M; Neuber K; Moll I; Gutzmer R; Kapp A; Jess P; Näher H; Petzoldt D; Djawari D; Petzold O; Pföhler C; Reinhold U; Tilgen W; Kaatz M; Elsner P; Möller M; Hauschild A; Jöckel A; Mauch C; Krieg T; Hoffmann U; Schadendorf D; Pierfrancesco Z; Daniel E; Vigl E; Böttjer J; Hartig C; Stadler R; Nashan D; Luger T; Pelzer P; Hölzle E; Coras B; Stolz W; Landthaler M; Ebisch MA; Zimmermann R; Gross G; Radny P; Eigentler TK; Garbe C; Mooser G; Lange M; Peter RU; Heinzerling L; Dummer R; Knopf B
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99. Ives NJ, Stowe RL, Lorigan P, Wheatley K: Chemotherapy compared with biochemotherapy for the treatment of metastatic melanoma: a meta-analysis of 18 trials involving 2,621 patients. J Clin Oncol; 2007 Dec 1;25(34):5426-34
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  • [Title] Chemotherapy compared with biochemotherapy for the treatment of metastatic melanoma: a meta-analysis of 18 trials involving 2,621 patients.
  • PURPOSE: To assess the effect of adding interferon-alpha (IFN) +/- interleukin-2 (IL-2) to chemotherapy in patients with metastatic melanoma.
  • METHODS A published data meta-analysis of trials of biochemotherapy versus chemotherapy in patients with metastatic melanoma was undertaken.
  • End points evaluated were rates of partial response (PR), complete response (CR) and overall (partial + complete) response (OR); response duration; progression-free survival; overall survival (OS); and toxicity.
  • The only subgroup analysis performed was by type of immunotherapy, with trials divided according to whether IFN only or IFN and IL-2 were administered in the biochemotherapy arm.
  • RESULTS: Eighteen randomized trials were identified: 11 trials of chemotherapy +/- IFN and seven trials of chemotherapy +/- IFN and IL-2.
  • More than 2,600 patients were entered onto the trials, with 555 responses and 2,039 deaths.
  • There was a clear benefit for biochemotherapy for PR (odds ratio = 0.66; 95% CI, 0.53 to 0.82; P = .0001), CR (odds ratio = 0.50; 95% CI, 0.35 to 0.73; P = .0003) and OR (odds ratio = 0.59; 95% CI, 0.49 to 0.72; P < .00001).
  • In contrast, there was no benefit overall in OS (odds ratio = 0.99; 95% CI, 0.91 to 1.08; P = .9), but there was evidence of heterogeneity of treatment effect between the individual trials (P = .006).
  • CONCLUSION: This meta-analysis provides a comprehensive summary of all the data currently available, and shows that although biochemotherapy clearly improves response rates, this does not appear to translate into a survival benefit.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Interferon-alpha / administration & dosage. Interleukin-2 / administration & dosage. Melanoma / drug therapy

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  • (PMID = 18048825.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Interleukin-2
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100. Sondak VK: Adjuvant therapy for melanoma. Cancer J; 2001 Jul-Aug;7 Suppl 1:S24-7
The Lens. Cited by Patents in .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Adjuvant therapy for melanoma.
  • Patients with deep primaries (> or = 4 mm) or regional lymph node involvement often require adjuvant therapy in addition to surgery to successfully treat melanoma.
  • Randomized trials of IFN-alpha adjuvant therapy have demonstrated statistically significant improvements in disease-free and overall survival rates, leading to approval by the United States Food and Drug Administration of the use of 1 year of intensive IFN-alpha2b following surgical resection of high-risk disease.
  • A study comparing high-dose IFN with the ganglioside vaccine GMK was terminated early when the Data Safety Monitoring Committee concluded that the high-dose IFN treatment arm was associated with highly significantly improved relapse-free and overall survival.
  • Studies of IFN-alpha in stage I and II melanoma are reviewed.
  • In addition to adjuvant therapy with IFN-alpha, various other treatment strategies appear promising.
  • Adjuvant vaccine therapy may be useful for treatment of cutaneous melanoma.
  • Polyvalent melanoma vaccines are discussed as a potential adjuvant therapy.
  • Finally, nonrandomized preliminary studies suggest that postoperative radiation to the neck or axilla after radical lymph node dissection may decrease regional recurrence rates in node-positive patients, supporting the selective use of radiation therapy for melanoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Melanoma / drug therapy. Melanoma / radiotherapy. Skin Neoplasms / drug therapy. Skin Neoplasms / radiotherapy
  • [MeSH-minor] Cancer Vaccines / therapeutic use. Chemotherapy, Adjuvant. Humans. Interferon-alpha / therapeutic use. Interferon-gamma / therapeutic use. Radiotherapy, Adjuvant

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  • (PMID = 11504282.001).
  • [ISSN] 1528-9117
  • [Journal-full-title] Cancer journal (Sudbury, Mass.)
  • [ISO-abbreviation] Cancer J
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Cancer Vaccines; 0 / Interferon-alpha; 82115-62-6 / Interferon-gamma
  • [Number-of-references] 35
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