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1. Whitehead RP, Moon J, McCachren SS, Hersh EM, Samlowski WE, Beck JT, Tchekmedyian NS, Sondak VK, Southwest Oncology Group: A Phase II trial of vinorelbine tartrate in patients with disseminated malignant melanoma and one prior systemic therapy: a Southwest Oncology Group study. Cancer; 2004 Apr 15;100(8):1699-704
Hazardous Substances Data Bank. VINBLASTINE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A Phase II trial of vinorelbine tartrate in patients with disseminated malignant melanoma and one prior systemic therapy: a Southwest Oncology Group study.
  • BACKGROUND: Single-agent chemotherapy with dacarbazine continues to be the standard of care for the treatment of metastatic melanoma.
  • However, there is a large population of patients who have failed first-line therapy and might benefit from additional treatment.
  • In the current study, the authors evaluated the antitumor effects and toxicity of vinorelbine therapy in patients who had failed one prior systemic therapy.
  • METHODS: Patients were required to have a histologic diagnosis of melanoma and be of Stage IV with measurable disease, a Southwest Oncology Group (SWOG) performance status (PS) of 0-2, no evidence of brain metastases, and adequate bone marrow and liver function.
  • Treatment was comprised of vinorelbine given at a dose of 30 mg/m(2)/week by intravenous bolus.
  • There were no complete or partial responses observed, for a response rate of 0 of the 21 patients studied (95% confidence interval [95% CI], 0-16%); the study closed after the first stage of accrual.
  • CONCLUSIONS: Despite impressive preclinical activity against melanoma, vinorelbine does not appear to have enough clinical activity to be of interest in previously treated patients with disseminated melanoma.
  • The progression-free and overall survival results noted in previously treated patients in the current study were similar to results reported in prior SWOG Phase II trials in untreated patients.
  • The group of previously treated patients may be used to evaluate new agents for the treatment of disseminated melanoma.
  • [MeSH-major] Antineoplastic Agents, Phytogenic / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Vinblastine / analogs & derivatives. Vinblastine / therapeutic use
  • [MeSH-minor] Adult. Aged. Disease-Free Survival. Drug Resistance, Neoplasm. Female. Humans. Injections, Intravenous. Male. Middle Aged. Neoplasm Metastasis

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  • [Copyright] Copyright 2004 American Cancer Society.
  • (PMID = 15073859.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA13612; United States / NCI NIH HHS / CA / CA20319; United States / NCI NIH HHS / CA / CA22433; United States / NCI NIH HHS / CA / CA32102; United States / NCI NIH HHS / CA / CA35176; United States / NCI NIH HHS / CA / CA35431; United States / NCI NIH HHS / CA / CA37981; United States / NCI NIH HHS / CA / CA38926; United States / NCI NIH HHS / CA / CA42777; United States / NCI NIH HHS / CA / CA45807; United States / NCI NIH HHS / CA / CA46441; United States / NCI NIH HHS / CA / CA58348; United States / NCI NIH HHS / CA / CA58861; United States / NCI NIH HHS / CA / CA63850; United States / NCI NIH HHS / CA / CA67575; United States / NCI NIH HHS / CA / CA76132
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Phytogenic; 5V9KLZ54CY / Vinblastine; Q6C979R91Y / vinorelbine
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2. 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
Hazardous Substances Data Bank. DACARBAZINE .

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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.
  • [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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3. Eisen T, Trefzer U, Hamilton A, Hersey P, Millward M, Knight RD, Jungnelius JU, Glaspy J: Results of a multicenter, randomized, double-blind phase 2/3 study of lenalidomide in the treatment of pretreated relapsed or refractory metastatic malignant melanoma. Cancer; 2010 Jan 1;116(1):146-54
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  • [Title] Results of a multicenter, randomized, double-blind phase 2/3 study of lenalidomide in the treatment of pretreated relapsed or refractory metastatic malignant melanoma.
  • BACKGROUND: The results of an international, multicenter, randomized, double-blind, controlled study assessing the efficacy and safety of lenalidomide treatment in patients with refractory stage IV metastatic malignant melanoma are reported.
  • METHODS: The study compared treatment with lenalidomide (25 mg/d on Days 1-21 of a 28-day cycle) to placebo in 306 patients with metastatic malignant melanoma.
  • Treatment was continued until progression of disease or unacceptable toxicity.
  • RESULTS: There were no significant differences between lenalidomide and placebo in overall survival (median 5.9 months vs 7.4 months, respectively; P = .32), time to progression (median 3.0 months vs 2.1 months; P = .19), or Response Evaluation Criteria in Solid Tumors tumor response (5.3% vs 5.8%; P = .82).
  • None of the patients given placebo discontinued treatment because of treatment-related adverse events, compared with 4.6% of those treated with lenalidomide.
  • Treatment-related myelosuppression was observed in 2.0% of patients treated with placebo and 7.3% of patients treated with lenalidomide.
  • CONCLUSIONS: This study showed that treatment with lenalidomide (25 mg/d) has a manageable safety profile in patients with previously treated metastatic malignant melanoma but no benefit in tumor response, time to progression, or overall survival in these patients.
  • Future trials for treatment of metastatic malignant melanoma with lenalidomide should focus on its use in combination therapies.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Thalidomide / analogs & derivatives
  • [MeSH-minor] Disease Progression. Double-Blind Method. Drug Resistance, Neoplasm. Female. Humans. Male. Middle Aged. Neoplasm Metastasis. Recurrence. Retreatment

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  • [Copyright] Copyright 2010 American Cancer Society.
  • (PMID = 19862820.001).
  • [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; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 4Z8R6ORS6L / Thalidomide; F0P408N6V4 / lenalidomide
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4. Chen KG, Leapman RD, Zhang G, Lai B, Valencia JC, Cardarelli CO, Vieira WD, Hearing VJ, Gottesman MM: Influence of melanosome dynamics on melanoma drug sensitivity. J Natl Cancer Inst; 2009 Sep 16;101(18):1259-71
Hazardous Substances Data Bank. VINBLASTINE .

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  • [Title] Influence of melanosome dynamics on melanoma drug sensitivity.
  • BACKGROUND: Malignant melanomas are intrinsically resistant to many conventional treatments, such as radiation and chemotherapy, for reasons that are poorly understood.
  • Here we propose and test a model that explains drug resistance or sensitivity in terms of melanosome dynamics.
  • METHODS: The growth and sensitivity to cisplatin of MNT-1 cells, which are melanotic and enriched with mature stage III and IV melanosomes, and SK-MEL-28 cells, which have only immature stage I and II melanosomes, were compared using clonogenic assays.
  • Differences in pigmentation, melanosome stages, melanosome number, and cellular structures in different cell lines in response to various treatments were examined by electron microscopy.
  • The relative numbers of melanosomes of different stages were compared after treatment with 1-phenyl-2-thiourea.
  • The relationship between drug transporter function and endogenous melanogenic toxicity was assessed by treating cells with the cyclosporin analog PSC-833 and by assessing vacuole formation and cell growth inhibition.
  • After treatment with 6.7 microM CDDP for 72 hours, the number of stage II-III melanosomes in surviving MNT-1 cells was 6.8-fold that of untreated cells.
  • Modulation of MNT-1 cells to earlier-stage (II, II-III, III) melanosomes by treatment with the tyrosinase inhibitor 1-phenyl-2-thiourea dramatically increased CDDP resistance.
  • CONCLUSIONS: Melanosome dynamics (including their biogenesis, density, status, and structural integrity) regulate the drug resistance of melanoma cells.
  • Manipulation of melanosome functions may be an effective way to enhance the therapeutic activity of anticancer drugs against melanoma.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / pharmacology. Drug Resistance, Neoplasm. Melanoma / drug therapy. Melanoma / pathology. Melanosomes / drug effects. Melanosomes / ultrastructure. Skin Neoplasms / drug therapy. Skin Neoplasms / pathology
  • [MeSH-minor] Animals. Cell Death / drug effects. Cell Line, Tumor. Cisplatin / pharmacology. Cyclosporins / pharmacology. Doxorubicin / pharmacology. Fluorescent Antibody Technique, Indirect. Humans. Melanoma, Experimental / drug therapy. Melanoma, Experimental / pathology. Mice. Microscopy, Confocal. Microscopy, Electron. Verapamil / pharmacology. Vinblastine / pharmacology

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  • (PMID = 19704071.001).
  • [ISSN] 1460-2105
  • [Journal-full-title] Journal of the National Cancer Institute
  • [ISO-abbreviation] J. Natl. Cancer Inst.
  • [Language] eng
  • [Grant] United States / Intramural NIH HHS / / Z99 NS999999
  • [Publication-type] Journal Article; Research Support, N.I.H., Intramural; Research Support, U.S. Gov't, Non-P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Cyclosporins; 121584-18-7 / valspodar; 5V9KLZ54CY / Vinblastine; 80168379AG / Doxorubicin; CJ0O37KU29 / Verapamil; Q20Q21Q62J / Cisplatin
  • [Other-IDs] NLM/ PMC2744727
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5. McClay EF, McClay ME, Monroe L, Baron PL, Cole DJ, O'Brien PH, Metcalf JS, Maize JC: The effect of tamoxifen and cisplatin on the disease-free and overall survival of patients with high risk malignant melanoma. Br J Cancer; 2000 Jul;83(1):16-21
Hazardous Substances Data Bank. DEXAMETHASONE .

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  • [Title] The effect of tamoxifen and cisplatin on the disease-free and overall survival of patients with high risk malignant melanoma.
  • The adjuvant treatment of high-risk malignant melanoma remains problematic.
  • Previously we reported moderate success in the treatment of metastatic disease using tamoxifen, cisplatin, dacarbazine and carmustine.
  • Based upon data that suggested tamoxifen and cisplatin were the active agents in this regimen, we initiated a phase II trial of this combination in the adjuvant setting.
  • During the first 2 years of follow-up, patients were evaluated every 2 months with a history, physical exam, laboratory work and computed tomography scans of the chest, abdomen and pelvis every 4 months.
  • No effect of gender or number of positive lymph nodes was noted, however, stage of disease prior treatment was a factor.
  • These preliminary results suggest that there is a positive impact of tamoxifen and cisplatin on both the DFS and OS of high-risk malignant melanoma patients.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Chemotherapy, Adjuvant. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Antiemetics / therapeutic use. Cisplatin / administration & dosage. Cisplatin / adverse effects. Combined Modality Therapy. Dexamethasone / therapeutic use. Disease-Free Survival. Female. Follow-Up Studies. Granisetron / therapeutic use. Humans. Life Tables. Lymphatic Metastasis. Male. Middle Aged. Nausea / chemically induced. Nausea / prevention & control. Neoplasm Metastasis. Neoplasm Staging. Ondansetron / therapeutic use. Prognosis. Risk. Survival Analysis. Tamoxifen / administration & dosage. Tamoxifen / adverse effects. Treatment Outcome. Vomiting / chemically induced. Vomiting / prevention & control

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  • (PMID = 10883662.001).
  • [ISSN] 0007-0920
  • [Journal-full-title] British journal of cancer
  • [ISO-abbreviation] Br. J. Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA52151
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] SCOTLAND
  • [Chemical-registry-number] 0 / Antiemetics; 094ZI81Y45 / Tamoxifen; 4AF302ESOS / Ondansetron; 7S5I7G3JQL / Dexamethasone; Q20Q21Q62J / Cisplatin; WZG3J2MCOL / Granisetron
  • [Other-IDs] NLM/ PMC2374536
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6. Croghan GA, Suman VJ, Maples WJ, Albertini M, Linette G, Flaherty L, Eckardt J, Ma C, Markovic SN, Erlichman C: A study of paclitaxel, carboplatin, and bortezomib in the treatment of metastatic malignant melanoma: a phase 2 consortium study. Cancer; 2010 Jul 15;116(14):3463-8
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  • [Title] A study of paclitaxel, carboplatin, and bortezomib in the treatment of metastatic malignant melanoma: a phase 2 consortium study.
  • BACKGROUND: Chemotherapy has not been reported to have a significant impact on survival for patients with metastatic melanoma.
  • A phase 1 trial of this 3-drug combination reported that 6 of 28 patients treated with bortezomib followed by paclitaxel and carboplatin achieved a partial response (including 2 of 5 patients with metastatic melanoma).
  • METHODS: A 2-stage phase 2 clinical trial was conducted to assess the antitumor activity of this 3-agent combination in patients with metastatic melanoma who had received at most 1 prior chemotherapy for metastatic disease.
  • Treatment included bortezomib at a dose of 1.3 mg/m2 intravenously on Days 1, 4, and 8; paclitaxel at a dose of 175 mg/m2; and carboplatin at an area under the concentration (AUC) of 6 on Day 2 of a 21-day cycle.
  • Three patients discontinued treatment due to persistent grade 4 (based on National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]) neutropenia with grade 3 leukopenia (2 patients) or grade 4 pulmonary embolism (1 patient).
  • CONCLUSIONS: Due to insufficient clinical efficacy, this trial did not proceed to second-stage accrual.

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  • [Copyright] Copyright (c) 2010 American Cancer Society.
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  • (PMID = 20564112.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CM / N01 CM062204; United States / NCI NIH HHS / CM / N01 CM062205; United States / NIGMS NIH HHS / GM / R01 GM062205; United States / NCI NIH HHS / CM / N01 CM62205
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Boronic Acids; 0 / Pyrazines; 69G8BD63PP / Bortezomib; BG3F62OND5 / Carboplatin; P88XT4IS4D / Paclitaxel
  • [Other-IDs] NLM/ NIHMS189760; NLM/ PMC3860743
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7. Hutchins LF, Moon J, Clark JI, Thompson JA, Lange MK, Flaherty LE, Sondak VK: Evaluation of interferon alpha-2B and thalidomide in patients with disseminated malignant melanoma, phase 2, SWOG 0026. Cancer; 2007 Nov 15;110(10):2269-75
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  • [Title] Evaluation of interferon alpha-2B and thalidomide in patients with disseminated malignant melanoma, phase 2, SWOG 0026.
  • BACKGROUND: Southwest Oncology Group protocol 0026 evaluated interferon alpha-2b plus thalidomide in patients with disseminated melanoma.
  • METHODS: Twenty-six patients with Stage IV melanoma, measurable or nonmeasurable disease, performance status of 0-2, and adequate renal and hepatic functions were registered.
  • One prior systemic therapy for Stage IV disease was required.
  • RESULTS: After 2 sudden deaths and 1 grade 4 treatment-related pulmonary embolism, this study was temporarily closed.
  • The relationship of these events to the treatment was worrisome but not definitive.
  • Grade 3 treatment-related adverse events occurred in 14 of 26 patients.
  • No treatment responses were seen in the 22 evaluable patients.
  • [MeSH-major] Interferon-alpha / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Thalidomide / therapeutic use

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  • [Copyright] (c) 2007 American Cancer Society.
  • (PMID = 17932881.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA12644; United States / NCI NIH HHS / CA / CA20319; United States / NCI NIH HHS / CA / CA32102; United States / NCI NIH HHS / CA / CA35090; United States / NCI NIH HHS / CA / CA35178; United States / NCI NIH HHS / CA / CA35261; United States / NCI NIH HHS / CA / CA37981; United States / NCI NIH HHS / CA / CA38926; United States / NCI NIH HHS / CA / CA45560; United States / NCI NIH HHS / CA / CA45808; United States / NCI NIH HHS / CA / CA46368; United States / NCI NIH HHS / CA / CA58658; United States / NCI NIH HHS / CA / CA58861; United States / NCI NIH HHS / CA / CA58882; United States / NCI NIH HHS / CA / CA76447
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Recombinant Proteins; 4Z8R6ORS6L / Thalidomide; 99210-65-8 / interferon alfa-2b
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8. Lafuma A, Dreno B, Delaunay M, Emery C, Fagnani F, Hieke K, Bonerandi JJ, Grob JJ, French Cooperative Group on Melanoma: Economic analysis of adjuvant therapy with interferon alpha-2a in stage II malignant melanoma. Eur J Cancer; 2001 Feb;37(3):369-75
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  • [Title] Economic analysis of adjuvant therapy with interferon alpha-2a in stage II malignant melanoma.
  • Using the trial demonstrating that interferonalpha-2a (IFNalpha-2a) is efficacious as adjuvant therapy in stage II melanoma, we evaluate its outcomes and economic consequences.
  • Using rates observed in the 5-year trial and published figures, survival and Q-TWIST (Time Without Symptoms and Toxicity) were extrapolated to a 10-year and lifetime horizon.
  • Patients in the IFNalpha-2a-group have an additional 0.26 years in life-expectancy over a 5-year time period (P=0.046), 0.67 years over a 10-year period and 2.59 years over a lifetime.
  • Cost-effectiveness of IFNalpha-2a in stage II melanoma compares favourably with estimates for widely used therapies in the oncological field.
  • [MeSH-major] Antineoplastic Agents / economics. Interferon-alpha / economics. Melanoma / economics. Skin Neoplasms / economics
  • [MeSH-minor] Adult. Aged. Cohort Studies. Cost-Benefit Analysis. Direct Service Costs. Drug Costs. Humans. Middle Aged. Neoplasm Recurrence, Local / drug therapy. Neoplasm Recurrence, Local / economics. Neoplasm Staging. Quality of Life. Randomized Controlled Trials as Topic. Recombinant Proteins. Sensitivity and Specificity. Survival Analysis. Treatment Outcome

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  • (PMID = 11239759.001).
  • [ISSN] 0959-8049
  • [Journal-full-title] European journal of cancer (Oxford, England : 1990)
  • [ISO-abbreviation] Eur. J. Cancer
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 76543-88-9 / interferon alfa-2a
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9. Neuber K, Reinhold U, Deutschmann A, Pföhler C, Mohr P, Pichlmeier U, Baumgart J, Hauschild A: Second-line chemotherapy of metastatic malignant melanoma with intravenous treosulfan: a phase II multicentre trial. Melanoma Res; 2003 Feb;13(1):81-5
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  • [Title] Second-line chemotherapy of metastatic malignant melanoma with intravenous treosulfan: a phase II multicentre trial.
  • The purpose of this multicentre phase II trial was to evaluate time to progression, survival time, rate of objective tumour response and toxicity of second-line intravenous treosulfan chemotherapy in stage IV melanoma patients.
  • Thirty-one patients with measurable stage IV malignant melanoma and prior chemotherapy with a dacarbazine-containing regimen were included.
  • Patients were evaluated for tumour response, survival time and toxicity.
  • Five patients (19%) showed no change and 21 had progressive disease after treosulfan treatment.
  • The median time to progression was 1.8 months (95% confidence interval [CI] 1.6-2.1 months) and the median overall survival was 6.5 months (95% CI 3.1-10 months).
  • In conclusion, intravenous treosulfan treatment does not induce objective response rates when used as a second-line treatment of metastatic malignant melanoma.
  • [MeSH-major] Antineoplastic Agents, Alkylating / therapeutic use. Busulfan / analogs & derivatives. Busulfan / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Disease Progression. Female. Humans. Infusions, Intravenous. Male. Middle Aged. Neoplasm Staging. Salvage Therapy. Survival Rate. Time Factors. Treatment Outcome

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  • (PMID = 12569289.001).
  • [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; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; CO61ER3EPI / treosulfan; G1LN9045DK / Busulfan
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10. Schmidt-Hieber M, Schmittel A, Thiel E, Keilholz U: A phase II study of bendamustine chemotherapy as second-line treatment in metastatic uveal melanoma. Melanoma Res; 2004 Dec;14(6):439-42
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  • [Title] A phase II study of bendamustine chemotherapy as second-line treatment in metastatic uveal melanoma.
  • Uveal melanoma is the most frequent primary malignant neoplasm of the eye and has a poor prognosis in metastatic stage.
  • We conducted a phase II trial to assess the second-line activity and toxicity of bendamustine hydrochloride, a nucleoside analogue with alkylating activity.
  • Inclusion criteria were a Karnofsky performance status of > or = 60% and progressive disease during or after first-line chemotherapy.
  • We conclude that bendamustine is ineffective as second-line chemotherapy for metastatic uveal melanoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Melanoma / drug therapy. Nitrogen Mustard Compounds / therapeutic use. Skin Neoplasms / drug therapy. Uveal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Bendamustine Hydrochloride. Female. Humans. Infusions, Intravenous. Male. Middle Aged. Neoplasm Staging. Salvage Therapy. Survival Rate. Treatment Outcome

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  • (PMID = 15577312.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Nitrogen Mustard Compounds; 981Y8SX18M / Bendamustine Hydrochloride
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11. DiFronzo LA, Gupta RK, Essner R, Foshag LJ, O'Day SJ, Wanek LA, Stern SL, Morton DL: Enhanced humoral immune response correlates with improved disease-free and overall survival in American Joint Committee on Cancer stage II melanoma patients receiving adjuvant polyvalent vaccine. J Clin Oncol; 2002 Aug 1;20(15):3242-8
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  • [Title] Enhanced humoral immune response correlates with improved disease-free and overall survival in American Joint Committee on Cancer stage II melanoma patients receiving adjuvant polyvalent vaccine.
  • PURPOSE: Although the improved overall survival (OS) of patients who receive Canvaxin (CancerVax Corp, Carlsbad, CA) polyvalent vaccine (PV) immunotherapy for metastatic melanoma has been correlated with cellular and humoral immune responses, the mechanisms of vaccine immunotherapy for early-stage melanoma are unclear.
  • Specific immune responses to tumor-associated antigens might correlate with disease-free survival (DFS) and OS in patients receiving adjuvant PV therapy for primary melanoma.
  • PATIENTS AND METHODS: Eighty-three patients received PV plus bacille Calmette-Guérin after wide excision of American Joint Committee on Cancer stage II melanoma.
  • Humoral and cellular responses during the first 12 weeks of adjuvant immunotherapy were assessed by serum antibody titers to a tumor-associated 90-kd glycoprotein antigen (TA90) expressed by PV, and by delayed-type hypersensitivity (DTH) skin testing with PV (PV-DTH).
  • CONCLUSION: These findings suggest that an increased IgM response in patients receiving PV therapy for stage II melanoma is associated with decreased recurrence and improved survival.
  • [MeSH-major] Cancer Vaccines / therapeutic use. Melanoma / immunology. Melanoma / therapy
  • [MeSH-minor] Antibody Formation / drug effects. Antibody Formation / immunology. Antigens, Neoplasm / immunology. BCG Vaccine / therapeutic use. Disease-Free Survival. Enzyme-Linked Immunosorbent Assay. Female. Humans. Hypersensitivity, Delayed / immunology. Immunoglobulin G / biosynthesis. Immunoglobulin M / biosynthesis. Male. Proportional Hazards Models. Survival Analysis

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  • (PMID = 12149297.001).
  • [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 / CA 12582; United States / NCI NIH HHS / CA / CA 29605
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antigens, Neoplasm; 0 / BCG Vaccine; 0 / Cancer Vaccines; 0 / Canvaxin; 0 / Immunoglobulin G; 0 / Immunoglobulin M
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12. Kavanagh D, Hill AD, Djikstra B, Kennelly R, McDermott EM, O'Higgins NJ: Adjuvant therapies in the treatment of stage II and III malignant melanoma. Surgeon; 2005 Aug;3(4):245-56
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  • [Title] Adjuvant therapies in the treatment of stage II and III malignant melanoma.
  • BACKGROUND: The incidence of cutaneous melanoma has increased during the past three decades.
  • Despite these improvements, 5-year survival rates for American Joint Committee on Cancer stage II and III disease range from 50%-90%.
  • METHODS: A review of the current literature concerning adjuvant therapies in patients with stage II and III malignant melanomas was undertaken.
  • RESULTS: The focus of adjuvant therapies has shifted from radiotherapy, BCG and levamisole to newer biological agents.
  • Interferon, interleukin and vaccines have been evaluated but none of these agents have demonstrated an increase in overall survival in patients with stage II and III melanoma.
  • CONCLUSION: At present, no adjuvant therapy improves overall survival in patients with stage II and III melanoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Chemotherapy, Adjuvant / methods. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Humans. Immunotherapy. Immunotherapy, Active. Interleukin-2 / therapeutic use. Neoplasm Staging. Radiotherapy, Adjuvant. Surgical Procedures, Operative

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  • (PMID = 16121769.001).
  • [ISSN] 1479-666X
  • [Journal-full-title] The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland
  • [ISO-abbreviation] Surgeon
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] Scotland
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interleukin-2
  • [Number-of-references] 89
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13. Martín-Algarra S, Espinosa E, Rubió J, López López JJ, Manzano JL, Carrión LA, Plazaola A, Tanovic A, Paz-Ares L: Phase II study of weekly Kahalalide F in patients with advanced malignant melanoma. Eur J Cancer; 2009 Mar;45(5):732-5
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  • [Title] Phase II study of weekly Kahalalide F in patients with advanced malignant melanoma.
  • This phase II clinical trial evaluated the antitumour response of Kahalalide F (KF) 650 microg/m(2) given as a 1-h weekly infusion in advanced malignant melanoma patients, both untreated and those who relapsed or progressed after one line of systemic therapy.
  • Of 24 enrolled patients (median age, 55 years; range, 28-89), 14 patients had been previously treated with chemotherapy or biological therapy.
  • No RECIST responses occurred; five chemotherapy-naïve patients with cutaneous melanoma had disease stabilisation for > or = 3 months; median progression-free survival was 1.7 months (95% CI, 1.2-1.9 months); and median overall survival was 10.8 months (95% CI, 5.0-upper limit not reached).
  • KF was a well-tolerated and safe chemotherapy regimen.
  • Despite a favourable safety profile, this trial was closed after the first stage because of the lack of objective response in patients with malignant melanoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Depsipeptides / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Female. Humans. Male. Middle Aged. Treatment Outcome

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  • (PMID = 19186051.001).
  • [ISSN] 1879-0852
  • [Journal-full-title] European journal of cancer (Oxford, England : 1990)
  • [ISO-abbreviation] Eur. J. Cancer
  • [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 / Antineoplastic Agents; 0 / Depsipeptides; 149204-42-2 / kahalalide F
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14. Garbe C, Eigentler TK: [Therapy of malignant melanoma at the stage of distant metastasis]. Hautarzt; 2004 Feb;55(2):195-213
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  • [Title] [Therapy of malignant melanoma at the stage of distant metastasis].
  • [Transliterated title] Therappie des malignen Melanoms im Stadium der Fernmetastasierung.
  • Treatment of melanoma in the stage of distant metastasis aims on palliation and achievement of durable tumor remission with prolongation of survival.
  • As long as metastasis is confined to one organ system and is removable, surgery remains the treatment of first choice.
  • More extensive metastasis should be treated by chemotherapy or chemoimmunotherapy.
  • As these treatments are associated with substantially higher toxicity they have been widely abandoned.
  • Combined treatment with dacarbazine and interferon-alpha obtain tumor responses or stable disease in 40-50% and objective tumor remissions in 15-20% of patients.
  • Effective cancer vaccination strategies and blockade of melanoma specific target molecules are currently developed as new treatment options.
  • [MeSH-major] Dacarbazine / analogs & derivatives. Melanoma / secondary. Melanoma / therapy. Skin Neoplasms / therapy
  • [MeSH-minor] Antineoplastic Agents / administration & dosage. Antineoplastic Agents / therapeutic use. Antineoplastic Agents, Alkylating / administration & dosage. Antineoplastic Agents, Alkylating / therapeutic use. Antineoplastic Agents, Phytogenic / administration & dosage. Antineoplastic Agents, Phytogenic / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Bone Neoplasms / radiotherapy. Bone Neoplasms / secondary. Brain Neoplasms / diagnostic imaging. Brain Neoplasms / radiotherapy. Brain Neoplasms / secondary. Brain Neoplasms / surgery. Clinical Trials, Phase II as Topic. Clinical Trials, Phase III as Topic. Disease Progression. Humans. Immunotherapy. Interferon-alpha / administration & dosage. Interferon-alpha / therapeutic use. Interleukin-2 / administration & dosage. Interleukin-2 / therapeutic use. Liver Neoplasms / secondary. Liver Neoplasms / surgery. Lung Neoplasms / secondary. Lymphatic Metastasis. Neoplasm Metastasis. Nitrosourea Compounds / administration & dosage. Nitrosourea Compounds / therapeutic use. Organophosphorus Compounds / administration & dosage. Organophosphorus Compounds / therapeutic use. Palliative Care. Prognosis. Radiotherapy Dosage. Randomized Controlled Trials as Topic. Time Factors. Tomography, X-Ray Computed. Vindesine / administration & dosage. Vindesine / therapeutic use

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  • (PMID = 15043023.001).
  • [ISSN] 0017-8470
  • [Journal-full-title] Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete
  • [ISO-abbreviation] Hautarzt
  • [Language] ger
  • [Publication-type] Comparative Study; Journal Article; Review
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Antineoplastic Agents, Alkylating; 0 / Antineoplastic Agents, Phytogenic; 0 / Interferon-alpha; 0 / Interleukin-2; 0 / Nitrosourea Compounds; 0 / Organophosphorus Compounds; 7GR28W0FJI / Dacarbazine; GQ7JL9P5I2 / fotemustine; RSA8KO39WH / Vindesine; YF1K15M17Y / temozolomide
  • [Number-of-references] 51
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15. 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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  • [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.
  • 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.
  • [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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16. Atzpodien J, Morawek L, Fluck M, Reitz M: Bleomycin, vinorelbine and trofosfamide in relapsed stage IV cutaneous malignant melanoma patients. Cancer Chemother Pharmacol; 2009 Oct;64(5):901-5
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  • [Title] Bleomycin, vinorelbine and trofosfamide in relapsed stage IV cutaneous malignant melanoma patients.
  • PURPOSE: To evaluate the efficacy of bleomycin, vinorelbine, and trofosfamide (BVT) in 28 patients with pretreated relapsed AJCC stage IV cutaneous malignant melanoma.
  • METHODS: Patients in relapse after first- or second-line therapy received 8 mg/m(2) intravenous (i.v.) bleomycin, 25 mg/m(2) i.v. vinorelbine, on days 1 and 6, each, and oral (p.o.) trofosfamide 60 mg/m(2)/day, days 1-7.
  • BVT therapy was repeated every 5 weeks until progression of disease occurred.
  • RESULTS: Three patients (11%) reached a partial response; 5 (18%) patients showed stable disease, and 20 (71%) patients progressed upon BVT therapy.
  • Most side effects were limited to WHO grade I/II mild anemia, leucocytopenia, fatigue, nausea/vomiting, pain, and anorexia.
  • CONCLUSION: Treatment with BVT was efficient in 29% of pretreated relapsed stage IV cutaneous melanoma patients, with overall good tolerability and safety.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy

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  • (PMID = 19229537.001).
  • [ISSN] 1432-0843
  • [Journal-full-title] Cancer chemotherapy and pharmacology
  • [ISO-abbreviation] Cancer Chemother. Pharmacol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; 0 / Antineoplastic Agents, Alkylating; 0 / Antineoplastic Agents, Phytogenic; 11056-06-7 / Bleomycin; 5V9KLZ54CY / Vinblastine; 8N3DW7272P / Cyclophosphamide; H64JRU6GJ0 / trofosfamide; Q6C979R91Y / vinorelbine
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17. Meral R, Duranyildiz D, Tas F, Camlica H, Yasasever V, Kurul S, Dalay N: Prognostic significance of melanoma inhibiting activity levels in malignant melanoma. Melanoma Res; 2001 Dec;11(6):627-32
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prognostic significance of melanoma inhibiting activity levels in malignant melanoma.
  • This analytic (phase II) study aimed to investigate the hypothesis that the decline in serum melanoma-inhibiting activity (MIA) levels following initiation of treatment might have prognostic value.
  • The mean serum lactate dehydrogenase (LDH), MIA and S100 levels in patients with malignant melanoma before treatment were higher than in the control group.
  • A regression model was constructed to analyse the prognostic factors in patients with advanced stage malignant melanoma.
  • Therapy included surgical excision or lymph node dissection, hypofractionated radiotherapy, and immunotherapy or chemotherapy.
  • Blood samples were collected within 24 h before the initiation of systemic treatment and two or three times more at 20-28 day intervals.
  • Gender, primary tumour site, surgery, radiation therapy, serum S100 levels before systemic treatment and choice of chemotherapy were not correlated with the outcome.
  • In addition to the stage of disease, low serum LDH levels before systemic treatment and a decline in serum MIA levels following initiation of systemic treatment predicted a favourable outcome.
  • Persistence of high serum MIA levels despite systemic treatment predicts an unfavourable prognosis.
  • [MeSH-major] Melanoma / blood. Neoplasm Proteins / blood. Skin Neoplasms / blood

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  • [CommentIn] Melanoma Res. 2002 Dec;12(6):633 [12459654.001]
  • (PMID = 11725209.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Extracellular Matrix Proteins; 0 / MIA protein, human; 0 / Neoplasm Proteins; 0 / S100 Proteins; 0 / S100A1 protein; EC 1.1.1.27 / L-Lactate Dehydrogenase
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18. Eggermont AM, Punt CJ: Does adjuvant systemic therapy with interferon-alpha for stage II-III melanoma prolong survival? Am J Clin Dermatol; 2003;4(8):531-6
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  • [Title] Does adjuvant systemic therapy with interferon-alpha for stage II-III melanoma prolong survival?
  • The experience with interferon-alpha in malignant melanoma resembles, to some degree, the experience with various kinds of adjuvant immunotherapeutic agents where 25 years of phase III trials of adjuvant therapy in stage II-IIII melanoma have not defined a standard therapy.
  • Preliminary results regarding distant metastasis-free survival (the closest surrogate for overall survival available) of the very large European Organisation for Research and Treatment of Cancer (EORTC) 18952 trial suggests that there is a benefit with long-term low intermediate doses and support the anti-angiogenic concept of long-term maintenance treatment with interferon-alpha.
  • The efficacy of short-term high-dose and long-term intermediate-dose treatment is being investigated in new trials.
  • [MeSH-major] Interferon-alpha / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Antineoplastic Agents / administration & dosage. Antineoplastic Agents / therapeutic use. Clinical Trials as Topic. Disease-Free Survival. Humans

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  • (PMID = 12862495.001).
  • [ISSN] 1175-0561
  • [Journal-full-title] American journal of clinical dermatology
  • [ISO-abbreviation] Am J Clin Dermatol
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha
  • [Number-of-references] 37
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19. Ishihara K, Saida T, Yamamoto A, Japanese Skin Cancer Society Prognosis and Statistical Investigation Committee: Updated statistical data for malignant melanoma in Japan. Int J Clin Oncol; 2001 Jun;6(3):109-16
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Updated statistical data for malignant melanoma in Japan.
  • BACKGROUND: A statistical investigation was conducted of Japanese melanoma patients who had been registered by the Prognosis and Statistical Investigation Committee of the Japanese Skin Cancer Society.
  • METHODS: The data analyzed included age, sex, anatomical distribution, clinical features of primary lesions, Clark's subtype, tumor thickness, Clark's level, disease stage, and treatment.
  • In addition, the results of a nationwide survey of various types of skin malignancies, obtained from 101 medical institutions in Japan between 1987 and 1996, were analyzed.
  • RESULTS: The nationwide survey revealed that the number of patients with malignant melanoma showed a steady increase during the period 1987-1996 in Japan.
  • It is noteworthy that the numbers of actinic keratoses, a type of early squamous cell carcinoma in situ, showed a steep increase in recent years.
  • Results revealed in our study of the melanoma registry for the period 1987-1996 were as follows:.
  • (1) the male-to-female ratio was 1 to 1.06, (2) the survival rate of female patients was higher than that of male patients (10-year survival in group B: female, 71.6% vs male, 55.9%), (3) the commonest site of melanoma in both sexes was the sole of the foot, (4) with respect to Clark's subtype, acral lentiginous melanoma was commonest, accounting for about half of all melanomas, (5) nodular melanoma showed the worst prognosis among the subtypes, (6) patients in stage IIIB and stage IV had an unfavorable outcome, with 10-year survivals of less than 50% and less than 10%, respectively, (7) Clark's level of invasion, as well as Breslow's tumor thickness of the primary lesions, were confirmed to be important prognostic factors, and (8) prophylactic lymph node dissection in stage II and IIIA and chemotherapy in stage IV seemed to have limited effect on the prognosis.
  • CONCLUSION: The prognosis of advanced melanoma is poor, as it is highly resistant to chemotherapy.
  • Thus, to improve the prognosis, early detection is mandatory, and this is possible because this neoplasm appears as a distinctive pigmented lesion on the skin.
  • [MeSH-major] Melanoma / epidemiology. Neoplasm Staging. Registries. Skin Neoplasms / epidemiology
  • [MeSH-minor] Adult. Aged. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Female. Humans. Japan / epidemiology. Lymph Node Excision. Male. Middle Aged. Neoplasm Invasiveness. Prevalence. Prognosis

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  • (PMID = 11706778.001).
  • [ISSN] 1341-9625
  • [Journal-full-title] International journal of clinical oncology
  • [ISO-abbreviation] Int. J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Japan
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20. Mu XC, Tran TA, Ross JS, Carlson JA: Topoisomerase II-alpha expression in melanocytic nevi and malignant melanoma. J Cutan Pathol; 2000 May;27(5):242-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Topoisomerase II-alpha expression in melanocytic nevi and malignant melanoma.
  • Malignant melanoma (MM) is considered to be a chemotherapy-refractory tumor.
  • New anti-cancer drugs (e.g. etoposide) that target DNA topoisomerases (e.g. topoisomerase II-alpha (topo IIalpha)) show activity against a wide variety of solid tumors.
  • The rate of topo IIalpha labeling in dysplastic melanocytic nevi, radial growth phase MM, vertical growth phase MM and metastatic MM revealed significant differences amongst groups and a positive covariance with advancing stage (means: 0.3, 0.5, 5, and 8 '+' cells/hpf, respectively; r=0.3, all p < or = 0.02).
  • These findings indicate topo IIalpha as a potential therapeutic target and marker for MM.
  • Immunohistochemical analysis of disseminated MM may allow for correlation with clinical response and enable selection of candidates sensitive for specific chemotherapy.
  • [MeSH-major] Antigens, Neoplasm / metabolism. DNA Topoisomerases, Type II / metabolism. Isoenzymes / metabolism. Melanoma / enzymology. Nevus, Pigmented / enzymology. Skin Neoplasms / enzymology

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  • (PMID = 10847549.001).
  • [ISSN] 0303-6987
  • [Journal-full-title] Journal of cutaneous pathology
  • [ISO-abbreviation] J. Cutan. Pathol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] DENMARK
  • [Chemical-registry-number] 0 / Antigens, Neoplasm; 0 / DNA-Binding Proteins; 0 / Isoenzymes; EC 5.99.1.3 / DNA Topoisomerases, Type II; EC 5.99.1.3 / DNA topoisomerase II alpha
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21. Lewis KD, Robinson WA, McCarter M, Pearlman N, O'Day SJ, Anderson C, Amatruda TT, Baron A, Zeng C, Becker M, Dollarhide S, Matijevich K, Gonzalez R: Phase II multicenter study of neoadjuvant biochemotherapy for patients with stage III malignant melanoma. J Clin Oncol; 2006 Jul 1;24(19):3157-63
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  • [Title] Phase II multicenter study of neoadjuvant biochemotherapy for patients with stage III malignant melanoma.
  • PURPOSE: To determine the relapse-free survival, overall survival, and response rate of patients with stage III melanoma treated with neoadjuvant biochemotherapy in a multicenter setting.
  • PATIENTS AND METHODS: Patients with pathologically proven stage III melanoma, either via clinical detection or sentinel lymph node positivity, were eligible for enrollment.
  • CONCLUSION: The current study has expanded the preliminary evidence on neoadjuvant biochemotherapy for stage III melanoma.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Cisplatin / administration & dosage. Dacarbazine / administration & dosage. Female. Humans. Interferon-alpha / administration & dosage. Interleukin-2 / administration & dosage. Lymph Node Excision. Male. Middle Aged. Neoadjuvant Therapy. Neoplasm Recurrence, Local. Neoplasm Staging. Survival Analysis. Vinblastine / administration & dosage

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  • (PMID = 16809738.001).
  • [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 / P30 CA046934
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Interleukin-2; 5V9KLZ54CY / Vinblastine; 7GR28W0FJI / Dacarbazine; Q20Q21Q62J / Cisplatin
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22. Juergensen A, Holzapfel U, Hein R, Stolz W, Buettner R, Bosserhoff A: Comparison of two prognostic markers for malignant melanoma: MIA and S100 beta. Tumour Biol; 2001 Jan-Feb;22(1):54-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Comparison of two prognostic markers for malignant melanoma: MIA and S100 beta.
  • It has recently been shown that the serum level of melanoma-inhibitory protein (MIA) provides useful information for the therapy and follow-up of patients with malignant melanoma.
  • Previously, S100 beta has been described as a useful tumor marker for malignant melanoma.
  • In this study, we compare the significance of the two markers in follow-up, therapy outcome and prognosis by measuring MIA and S100 beta serum levels in 50 melanoma patients.
  • Serum levels were measured in patients with malignant melanomas of stages I-IV with at least 3 time points of measurement.
  • Serial MIA and S100 beta measurements were obtained from 32 patients with stage IV disease in parallel to chemotherapy and from 18 patients with a history of stage I and stage II disease during follow-up.
  • The response to chemotherapy in stage IV disease and relapse of melanoma during follow-up correlated with changes in MIA and S100 beta serum levels.
  • In conclusion, both markers are useful for detection of progression from localized to metastatic disease during follow-up and for monitoring therapy of advanced melanomas.
  • [MeSH-major] Biomarkers, Tumor / blood. Melanoma / blood. Neoplasm Proteins / blood. S100 Proteins / blood. Skin Neoplasms / blood
  • [MeSH-minor] Adult. Aged. Combined Modality Therapy. Disease Progression. Enzyme-Linked Immunosorbent Assay. Evaluation Studies as Topic. Extracellular Matrix Proteins. Female. Follow-Up Studies. Humans. Life Tables. Luminescent Measurements. Male. Middle Aged. Prognosis. Sensitivity and Specificity. Survival Analysis

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  • [Copyright] Copyright 2000 S. Karger AG, Basel.
  • (PMID = 11054027.001).
  • [ISSN] 1010-4283
  • [Journal-full-title] Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine
  • [ISO-abbreviation] Tumour Biol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Biomarkers, Tumor; 0 / Extracellular Matrix Proteins; 0 / MIA protein, human; 0 / Neoplasm Proteins; 0 / S100 Proteins; 0 / S100A1 protein
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23. Lewis KD, Gibbs P, O'Day S, Richards J, Weber J, Anderson C, Zeng C, Baron A, Russ P, Gonzalez R: A phase II study of biochemotherapy for advanced melanoma incorporating temozolomide, decrescendo interleukin-2 and GM-CSF. Cancer Invest; 2005;23(4):303-8
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  • [Title] A phase II study of biochemotherapy for advanced melanoma incorporating temozolomide, decrescendo interleukin-2 and GM-CSF.
  • Metastatic malignant melanoma remains a very difficult disease to treat.
  • Previous phase II studies using biochemotherapy (combination of platinum-containing chemotherapy with IL-2 and IFNalpha) have shown response rates of about 50%.
  • We report the results of a phase II study using a novel biochemotherapy regimen containing temozolomide, cisplatin, decrescendo IL-2, IFNalpha, and GM-CSF in the treatment of stage IV melanoma.
  • Seventy-one patients with histologically confirmed metastatic melanoma were enrolled between June 1998 and October 1999.
  • Prior chemotherapy or IL-2 was not permitted.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Antineoplastic Agents, Alkylating / administration & dosage. Brain Neoplasms / mortality. Brain Neoplasms / secondary. Dacarbazine / administration & dosage. Dacarbazine / analogs & derivatives. Eye Neoplasms / drug therapy. Eye Neoplasms / mortality. Eye Neoplasms / pathology. Granulocyte-Macrophage Colony-Stimulating Factor / administration & dosage. Humans. Interleukin-2 / administration & dosage. Middle Aged. Neoplasm Metastasis. Reproducibility of Results. Skin Neoplasms / drug therapy. Skin Neoplasms / mortality. Skin Neoplasms / pathology. Survival Analysis

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  • (PMID = 16100942.001).
  • [ISSN] 0735-7907
  • [Journal-full-title] Cancer investigation
  • [ISO-abbreviation] Cancer Invest.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / P30 CA46934
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; 0 / Interleukin-2; 7GR28W0FJI / Dacarbazine; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor; 85622-93-1 / temozolomide
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24. Eggermont AM: The role interferon-alpha in malignant melanoma remains to be defined. Eur J Cancer; 2001 Nov;37(17):2147-53
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  • [Title] The role interferon-alpha in malignant melanoma remains to be defined.
  • Because of its immunomodulatory effects, it has been extensively studied in melanoma patients.
  • Little antitumour activity has been demonstrated in metastatic stage IV melanoma, with overall response rates of 10-15%, which were not dose-related.
  • Yet, IFNalpha has been widely studied in the adjuvant setting for stage II and III disease.
  • Many trials have been underpowered, have used very heterogeneously mixed patient populations, a wide variety of doses and treatment schedules, and have suffered from early and unplanned analyses.
  • In light of the lack of impact on OS and the considerable to serious dose-dependent toxicity of IFNalpha, we do not have a clearly dose- and schedule-defined role for IFNalpha in the adjuvant setting and have no evidence for a benefit of IFNalpha in stage IV melanoma.
  • For the adjuvant setting, the main question: efficacy of very toxic high dose therapy versus efficacy of non-toxic long-term treatment will be answered by the mature data from the large US-Intergroup high-dose and EORTC intermediate-dose and long-term maintenance therapy trials.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Interferon-alpha / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Combined Modality Therapy. Dose-Response Relationship, Drug. Humans. Neoplasm Staging. Randomized Controlled Trials as Topic. Survival Rate

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  • (PMID = 11677100.001).
  • [ISSN] 0959-8049
  • [Journal-full-title] European journal of cancer (Oxford, England : 1990)
  • [ISO-abbreviation] Eur. J. Cancer
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha
  • [Number-of-references] 30
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25. Reiriz AB, Richter MF, Fernandes S, Cancela AI, Costa TD, Di Leone LP, Schwartsmann G: Phase II study of thalidomide in patients with metastatic malignant melanoma. Melanoma Res; 2004 Dec;14(6):527-31
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  • [Title] Phase II study of thalidomide in patients with metastatic malignant melanoma.
  • We evaluated the single-agent antitumour activity and toxicity profile of thalidomide in patients with metastatic malignant melanoma, as well as its plasma pharmacokinetics and pharmacodynamic effects [vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (b-FGF) levels].
  • A two-stage Gehan method was used with a stopping rule after 14 consecutive non-responding patients.
  • Other toxicities were oedema, neuropathy, dry skin, dry mouth, tremor and fatigue.
  • Serum levels of b-FGF and VEGF did not change significantly following drug administration.
  • In conclusion, thalidomide showed poor activity, but acceptable toxicity, in patients with metastatic melanoma.
  • [MeSH-major] Angiogenesis Inhibitors / therapeutic use. Melanoma / drug therapy. Neoplasm Recurrence, Local / drug therapy. Neovascularization, Pathologic / prevention & control. Skin Neoplasms / drug therapy. Thalidomide / therapeutic use
  • [MeSH-minor] Administration, Oral. Adult. Aged. Drug Administration Schedule. Female. Fibroblast Growth Factor 2 / metabolism. Humans. Maximum Tolerated Dose. Middle Aged. Survival Rate. Treatment Outcome. Vascular Endothelial Growth Factor A / metabolism

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  • (PMID = 15577325.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Angiogenesis Inhibitors; 0 / Vascular Endothelial Growth Factor A; 103107-01-3 / Fibroblast Growth Factor 2; 4Z8R6ORS6L / Thalidomide
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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.
  • Eligible patients had stage IV malignant melanoma with at least one measurable lesion.
  • 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. Tas F, Kurul S, Camlica H, Topuz E: Malignant melanoma in Turkey: a single institution's experience on 475 cases. Jpn J Clin Oncol; 2006 Dec;36(12):794-9
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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 in Turkey: a single institution's experience on 475 cases.
  • BACKGROUND: This study was performed to determine the characteristics and the clinical outcomes of patients with cutaneous melanoma in Turkey.
  • RESULTS: Of the 475 adult cases with complete staging procedure, the incidence of localized (stages I-II) disease was 301 (63.4%), and followed by node involved (stage III) and metastatic (stage IV) disease with the incidence of 117 (24.6%) and 57 (12.0%), respectively.
  • In cases with early/node negative stage, stage distribution was identical.
  • The superficial spreading type was the commonest histology (52.2%).
  • In cases with the node involved stage, the majority of patients had only one lymph node involved.
  • The five-year survival rates of patients with stages I-II and III disease were 63.6% and 36.6%, respectively.
  • Nodular histology subtype, deeper Breslow tumor depth, extensive invasion, presence of ulceration, advanced stage, presence of relapse, being male and elderly patient, presence of visceral recurrence, and high mitotic activity were found to be associated with poor prognosis for overall survival in localized disease.
  • Unresponsiveness to chemotherapy, visceral metastasis, multiple metastases and not given chemotherapy were the poor prognostic factors for overall survival.
  • [MeSH-major] Melanoma / epidemiology. Skin Neoplasms / epidemiology

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  • (PMID = 17060409.001).
  • [ISSN] 0368-2811
  • [Journal-full-title] Japanese journal of clinical oncology
  • [ISO-abbreviation] Jpn. J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Japan
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28. Dummer R, Garbe C, Thompson JA, Eggermont AM, Yoo K, Maier T, Bergstrom B: Randomized dose-escalation study evaluating peginterferon alfa-2a in patients with metastatic malignant melanoma. J Clin Oncol; 2006 Mar 1;24(7):1188-94
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  • [Title] Randomized dose-escalation study evaluating peginterferon alfa-2a in patients with metastatic malignant melanoma.
  • This open-label, randomized study evaluated the safety, tolerability, and efficacy of subcutaneous PEG-IFNalpha-2a in patients with metastatic malignant melanoma (stage IV American Joint Committee on Cancer staging system).
  • PATIENTS AND METHODS: PEG-IFNalpha-2a was administered subcutaneously at 180 (n = 48), 360 (n = 53), or 450 mug (n = 49) once weekly for 24 weeks, with maintenance therapy for responders.
  • The times to achieve a major response, duration of major response, rate of disease progression, and 12-month survival were similar between groups, although overall median survival was significantly different among the three groups (P = .0136).
  • CONCLUSION: PEG-IFNalpha-2a at doses up to 450 mug once weekly has shown good tolerability and similar efficacy to conventional IFNalpha and monochemotherapy in stage IV metastatic melanoma.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Antineoplastic Agents / adverse effects. Interferon-alpha / administration & dosage. Interferon-alpha / adverse effects. Melanoma / drug therapy. Melanoma / secondary. Polyethylene Glycols / administration & dosage. Polyethylene Glycols / adverse effects. Skin Neoplasms / pathology
  • [MeSH-minor] Adult. Aged. Disease Progression. Fatigue / chemically induced. Female. Fever / chemically induced. Humans. Male. Middle Aged. Nausea / chemically induced. Recombinant Proteins. Survival Analysis. Treatment Outcome

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  • (PMID = 16505439.001).
  • [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; Research Support, U.S. Gov't, Non-P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 0 / peginterferon alfa-2a; 30IQX730WE / Polyethylene Glycols; 76543-88-9 / interferon alfa-2a
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29. Wang Y, Cen Y, Li Z: [Therapeutic result of operation combined with large-dose of roferon-A for cutaneous malignant melanoma]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi; 2007 Jan;21(1):37-9
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  • [Title] [Therapeutic result of operation combined with large-dose of roferon-A for cutaneous malignant melanoma].
  • OBJECTIVE: To observe the effects of operation with large-dose of Roferon-A for cutaneous malignant melanoma.
  • METHODS: From January 1998 to December 2005, thirty-three patients with cutaneous malignant melanoma were treated.
  • In 33 patients, nine patients identified as clinical-stage I received singly enlarged-resection to the primary lesion and performed split-thickness skin graft dermoplasty or adjacent skin flap repair; twenty-three patients identified as clinical-stage II received enlarged-resection to the primary lesion and performed proximal lymphaden scavenge as well as received split-thickness skin graft dermoplasty; and one patient identified as clinical-stage III received palliative resection to the primary lesion.
  • RESULTS: There are no recidivation in the 9 patients of clinical-stage I.
  • There are 1 recidivation and 1 quit in all the 23 patients of clinical-stage II.
  • One patient of clinical-stage III died after 18 months of operation.
  • CONCLUSION: The operation combined with large-dose of Roferon-A after operation was a more effective way to treat cutaneous malignant melanoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Interferon-alpha / therapeutic use. Melanoma / drug therapy. Melanoma / surgery. Skin Neoplasms / drug therapy. Skin Neoplasms / surgery
  • [MeSH-minor] Adolescent. Adult. Aged. Female. Follow-Up Studies. Head and Neck Neoplasms / drug therapy. Head and Neck Neoplasms / pathology. Head and Neck Neoplasms / surgery. Humans. Injections, Intramuscular. Male. Middle Aged. Neoplasm Staging. Recombinant Proteins. Skin Transplantation. Surgical Flaps. Treatment Outcome. Young Adult

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  • (PMID = 17305002.001).
  • [ISSN] 1002-1892
  • [Journal-full-title] Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery
  • [ISO-abbreviation] Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi
  • [Language] chi
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] China
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interferon-alpha; 0 / Recombinant Proteins; 76543-88-9 / interferon alfa-2a
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30. Spitler LE, Grossbard ML, Ernstoff MS, Silver G, Jacobs M, Hayes FA, Soong SJ: Adjuvant therapy of stage III and IV malignant melanoma using granulocyte-macrophage colony-stimulating factor. J Clin Oncol; 2000 Apr;18(8):1614-21
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  • [Title] Adjuvant therapy of stage III and IV malignant melanoma using granulocyte-macrophage colony-stimulating factor.
  • PURPOSE: To evaluate granulocyte-macrophage colony-stimulating factor (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high risk of recurrence.
  • PATIENTS AND METHODS: Forty-eight assessable patients with stage III or IV melanoma were treated in a phase II trial with long-term, chronic, intermittent GM-CSF after surgical resection of disease.
  • Patients with stage III disease were required to have more than four positive nodes or a more than 3-cm mass.
  • Treatment cycles continued for 1 year or until disease recurrence.
  • GM-CSF was well tolerated; only one subject discontinued drug due to an adverse event (grade 2 injection site reaction).
  • CONCLUSION: GM-CSF may provide an antitumor effect that prolongs survival and disease-free survival in patients with stage III and IV melanoma who are clinically disease-free.
  • These results support institution of a prospective, randomized clinical trial to definitively determine the value of surgical adjuvant therapy with GM-CSF in such patients.
  • [MeSH-major] Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use. Melanoma / therapy. Skin Neoplasms / therapy
  • [MeSH-minor] Aged. Combined Modality Therapy. Disease-Free Survival. Female. Humans. Life Tables. Lymphatic Metastasis. Male. Survival Rate

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  • [CommentIn] J Clin Oncol. 2000 Apr;18(8):1603-5 [10764419.001]
  • (PMID = 10764421.001).
  • [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; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor
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31. Ishihara K, Saida T, Otsuka F, Yamazaki N, Prognosis and Statistical Investigation Committee of the Japanese Skin Cancer Society: Statistical profiles of malignant melanoma and other skin cancers in Japan: 2007 update. Int J Clin Oncol; 2008 Feb;13(1):33-41
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Statistical profiles of malignant melanoma and other skin cancers in Japan: 2007 update.
  • BACKGROUND: In the previous report of the Prognosis and Statistical Investigation Committee of the Japanese Skin Cancer Society, we tabulated data on patients with malignant melanoma who had been registered at major medical institutions (22 institutions on average) in Japan over 5-year periods from 1987 to 1991 (group A) and from 1992 to 1996 (group B).
  • METHODS: The numbers of melanoma patients registered were: 545 in group A (1987-1991), 699 in group B (1992-1996), and 821 in group C (1997-2001).
  • Because the International Union Against Cancer (UICC) TNM and stage classifications for malignant melanoma were changed substantially in 2002, analyses in the present investigation were performed according to the new classifications.
  • In addition, the numbers of patients with various kinds of skin malignancies, including not only malignant melanoma but also basal cell carcinoma, squamous cell carcinoma, mycosis fungoides, actinic keratosis, Bowen's disease, and Paget's disease, registered at approximately 100 medical institutions in Japan from 1987 to 2001, were also investigated and data were tabulated.
  • RESULTS: The nationwide survey of Japanese patients with malignant skin tumors from 1987 to 2001 showed that the most prevalent skin tumor was basal cell carcinoma, which increased year by year, followed by squamous cell carcinoma, and then by malignant melanoma.
  • The following results were obtained from the data for melanoma patients registered at major institutions from 1987 to 2001. (1) The overall 10-year survival rates for melanoma patients in each chronological group were ranked as: group C > B > A, although only the difference between groups C and A was statistically significant. (2) The male-to-female ratio ranged from 1: 0.97 to 1: 1.14, and the survival rate of female patients was higher than that of male patients (the 140-month survival rate was 70.6% in females and 60% in males). (3) Assessment of the age distribution showed that the number of patients increased rapidly from ages 40-49 years and reached a peak at around 60 years in all three groups. (4) The sole of the foot was the most common site of melanoma in both males and females, while melanomas on the lower limbs were also prevalent in females. (5) Acral lentiginous melanoma (ALM) was the most common type in all three groups, accounting for nearly 50% of the patients in each group.
  • The number of patients with superficial spreading melanoma (SSM) increased steadily over time and exceeded the number of patients with nodular melanoma (NM) in group C.
  • The prognosis of NM was the worst, while that of SSM was the most favorable. (6) The proportion of stage I patients was larger in group C than in groups A and B, but no significant difference among the groups was observed in the proportions of stage II, III, and IV patients.
  • For patients in stage III, the overall survival rate was higher in group C than that in group A or B, while there was no apparent difference in survival between the groups for patients in stage I or II.
  • For patients in stage IV, the survival rate in group C was slightly lower than that in group A or B. (7) In group C, the overall survival rates for substages III A, B, and C were ranked as III A > III B > III C. (8) The overall survival rates for stage IV M1a, M1b, and M1c were ranked as M1a > M1b > M1c.
  • In group C, the overall survival rate of stage IV patients with a normal serum lactic dehydrogenase (LDH) level was higher than that of patients with elevated LDH values. (9) Evaluation of the effects of some therapeutic procedures (prophylactic lymph node dissection and chemotherapy with and without interferon-beta) on the survivals of patients with melanoma was inconclusive and suggested the need for more studies in this area.
  • CONCLUSION: In Japan, the number of patients with malignant skin tumors has increased year by year.
  • The prognosis of patients with advanced malignant melanoma remains extremely poor, but that of patients in stage III has shown an improvement.
  • [MeSH-major] Melanoma / epidemiology. Skin Neoplasms / epidemiology

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  • [Cites] Int J Epidemiol. 1995 Oct;24(5):897-907 [8557445.001]
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  • (PMID = 18307017.001).
  • [ISSN] 1341-9625
  • [Journal-full-title] International journal of clinical oncology
  • [ISO-abbreviation] Int. J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Japan
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32. Lens MB: The role of biological response modifiers in malignant melanoma. Expert Opin Biol Ther; 2003 Dec;3(8):1225-31
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  • [Title] The role of biological response modifiers in malignant melanoma.
  • This article reviews the existing data in an attempt to address the role of biological response modifiers (IFN-alpha and IL-2) in the management of melanoma.
  • Eight prospective controlled Phase III trials evaluating IFN-alpha therapy are discussed.
  • As the results from these trials have been heterogeneous and inconsistent, the role of IFN-alpha in the adjuvant treatment of stage II and III melanoma patients remains to be defined.
  • IL-2 possesses modest antitumour activity in melanoma yielding objective response in approximately 15% of patients.
  • Many toxic effects are induced by high-dose IL-2 therapy.
  • Combinations of chemotherapy and biological response modifiers and their impact on tumour response and survival are discussed.
  • [MeSH-major] Immunologic Factors / therapeutic use. Interferon-alpha / therapeutic use. Melanoma / therapy. Skin Neoplasms / therapy
  • [MeSH-minor] Clinical Trials as Topic. Humans. Interferons / metabolism. Interleukin-2 / metabolism. Randomized Controlled Trials as Topic. Time Factors

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  • (PMID = 14640948.001).
  • [ISSN] 1471-2598
  • [Journal-full-title] Expert opinion on biological therapy
  • [ISO-abbreviation] Expert Opin Biol Ther
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Immunologic Factors; 0 / Interferon-alpha; 0 / Interleukin-2; 9008-11-1 / Interferons
  • [Number-of-references] 41
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33. Neuber K: Treosulfan in the treatment of metastatic melanoma: from chemosensitivity testing to clinical trials. Recent Results Cancer Res; 2003;161:159-79
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  • [Title] Treosulfan in the treatment of metastatic melanoma: from chemosensitivity testing to clinical trials.
  • The therapy of metastatic malignant melanoma is limited by poor responses and short overall survival.
  • Thus it remains important to identify and test potential new drugs in this disease.
  • Five highly chemoresistant melanoma cell lines and melanoma cells freshly isolated from metastases surgically resected from stage IV melanoma patients (n = 10) were incubated with treosulfan.
  • Three cell lines and eight of ten tested tumor cells isolated from melanoma metastases showed tumor growth inhibition after incubation with treosulfan.
  • Therefore, 14 patients with rapidly progressing stage IV malignant melanoma who were pretreated with at least one standard chemotherapy regimen received treosulfan.
  • In this population of patients with highly refractory advanced melanoma one complete remission (7.1%), two partial remissions (14.3%), and three cases of stable disease (21.4%) were observed.
  • Median time to progression and median overall survival for all patients measured from the beginning of treosulfan treatment were 5 months [95% confidence interval (CI) 1.98-2.57 months] and 9 months (95% CI 3.92-8.69 months), respectively.
  • On the basis of these data a multicenter phase II trial was initiated.
  • A total of 31 patients with stage IV melanoma were included and treated second-line with 8 g/m2 i.v. treosulfan.
  • Patients with treosulfan-sensitive melanoma metastases showed better response rates and prolonged survival compared with patients who were not tested before treosulfan treatment.
  • We therefore suggest further studies with first-line treosulfane alone or in combination with gemcitabine or cytosine arabinoside together with pretherapeutic chemosensitivity testing that may help to select patients who might benefit from specific chemotherapy.
  • [MeSH-major] Antineoplastic Agents, Alkylating / therapeutic use. Busulfan / analogs & derivatives. Busulfan / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adenosine Triphosphate / analysis. Adult. Aged. Aged, 80 and over. Biopsy. Disease Progression. Dose-Response Relationship, Drug. Drug Resistance, Neoplasm. Drug Screening Assays, Antitumor. Female. Humans. Luminescent Measurements. Lymphatic Metastasis. Male. Middle Aged. Neoplasm Staging. Survival Rate. Tumor Cells, Cultured / drug effects

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  • (PMID = 12528807.001).
  • [ISSN] 0080-0015
  • [Journal-full-title] Recent results in cancer research. Fortschritte der Krebsforschung. Progrès dans les recherches sur le cancer
  • [ISO-abbreviation] Recent Results Cancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; 8L70Q75FXE / Adenosine Triphosphate; CO61ER3EPI / treosulfan; G1LN9045DK / Busulfan
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34. 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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  • [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.
  • 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.
  • 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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35. Ribas A, Kirkwood JM, Atkins MB, Whiteside TL, Gooding W, Kovar A, Gillies SD, Kashala O, Morse MA: Phase I/II open-label study of the biologic effects of the interleukin-2 immunocytokine EMD 273063 (hu14.18-IL2) in patients with metastatic malignant melanoma. J Transl Med; 2009;7:68
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  • [Title] Phase I/II open-label study of the biologic effects of the interleukin-2 immunocytokine EMD 273063 (hu14.18-IL2) in patients with metastatic malignant melanoma.
  • BACKGROUND: To explore the biological activity of EMD 273063 (hu14.18-IL2), a humanized anti-GD2 monoclonal antibody fused to interleukin-2 (IL2), in patients with unresectable, stage IV cutaneous melanoma as measured by induction of immune activation at the tumor site and in peripheral blood.
  • Biopsies of tumor metastasis were performed prior to therapy and at day 10 of the first 2 cycles to study lymphocyte accumulation by immunohistochemistry.
  • RESULTS: Treatment was generally well tolerated and there were no study drug-related grade 4 adverse events.
  • Best response on therapy was stable disease in 2 patients.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Cytokines / therapeutic use. Interleukin-2 / therapeutic use. Melanoma / pathology. Melanoma / therapy. Skin Neoplasms / pathology. Skin Neoplasms / therapy
  • [MeSH-minor] Adult. Aged. Area Under Curve. Biopsy. Female. Follow-Up Studies. Half-Life. Humans. Immunohistochemistry. Male. Metabolic Clearance Rate. Middle Aged. Neoplasm Metastasis. Neoplasm Staging. Time Factors. Treatment Outcome

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  • (PMID = 19640287.001).
  • [ISSN] 1479-5876
  • [Journal-full-title] Journal of translational medicine
  • [ISO-abbreviation] J Transl Med
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase I; 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 / Cytokines; 0 / EMD 273063 antibody, human; 0 / Interleukin-2
  • [Other-IDs] NLM/ PMC2724499
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36. Lutzky J, Weber R, Nunez Y, Gillett M, Spitler L: A phase 1 study of granulocyte macrophage colony-stimulating factor (sargramostim) and escalating doses of thalidomide in patients with high-risk malignant melanoma. J Immunother; 2009 Jan;32(1):79-85
Hazardous Substances Data Bank. THALIDOMIDE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase 1 study of granulocyte macrophage colony-stimulating factor (sargramostim) and escalating doses of thalidomide in patients with high-risk malignant melanoma.
  • This phase 1 study evaluated the safety and tolerability of adjuvant treatment with subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF) administered in combination with escalating doses of thalidomide in patients with surgically resected stage II (T4), III, or IV melanoma at high risk for recurrence.
  • Adjuvant treatment included GM-CSF 125 microg/m2 subcutaneously for 14 days and thalidomide at an initial dose of 50 mg/d, escalated in cohorts of 3 to 6 patients each to a maximum of 400 mg/d followed by 14 days of rest.
  • Treatment was continued for up to 1 year in the absence of disease progression.
  • Of 19 patients treated, the most common toxicities were grade 1/2 constipation (68%), fatigue (58%), neuropathy (42%), bone and joint pain (37%), and dyspnea, dizziness, injection site skin reaction, and somnolence (32% each).
  • Thrombotic events in 3 of 19 patients (16%), including 1 treatment-related death, were the most serious adverse events and were thought to be due to thalidomide.
  • GM-CSF plus thalidomide as adjuvant therapy for patients with resected high-risk melanoma was associated with a high incidence of thrombotic events.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use. Immunosuppressive Agents / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Thalidomide / therapeutic use
  • [MeSH-minor] Adult. Aged. Female. Humans. Kaplan-Meier Estimate. Male. Middle Aged. Recombinant Proteins. Treatment Outcome

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  • (PMID = 19307996.001).
  • [ISSN] 1537-4513
  • [Journal-full-title] Journal of immunotherapy (Hagerstown, Md. : 1997)
  • [ISO-abbreviation] J. Immunother.
  • [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 / Adjuvants, Immunologic; 0 / Immunosuppressive Agents; 0 / Recombinant Proteins; 123774-72-1 / sargramostim; 4Z8R6ORS6L / Thalidomide; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor
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37. Clark JI, Moon J, Hutchins LF, Sosman JA, Kast WM, Da Silva DM, Liu PY, Thompson JA, Flaherty LE, Sondak VK: Phase 2 trial of combination thalidomide plus temozolomide in patients with metastatic malignant melanoma: Southwest Oncology Group S0508. Cancer; 2010 Jan 15;116(2):424-31
Hazardous Substances Data Bank. THALIDOMIDE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase 2 trial of combination thalidomide plus temozolomide in patients with metastatic malignant melanoma: Southwest Oncology Group S0508.
  • BACKGROUND: In limited institution phase 2 studies, thalidomide and temozolomide has yielded response rates (RRs) up to 32% for advanced melanoma, leading to the use of this combination as "standard" by some.
  • We conducted a multicenter phase 2 trial to better define the clinical efficacy of thalidomide and temozolomide and the immune modulatory effects of thalidomide, when combined with temozolomide, in patients with metastatic melanoma.
  • METHODS: Patients must have had stage IV cutaneous melanoma, no active brain metastases, Zubrod PS 0-1, up to 1 prior systemic therapy excluding thalidomide, temozolomide, or dacarbazine, adequate organ function, and given informed consent.
  • RESULTS: Sixty-four patients were enrolled; 2 refused treatment.
  • One treatment-related death occurred from myocardial infarction; 3 other grade 4 events occurred, including pulmonary embolism, neutropenia, and central nervous system (CNS) ischemia.

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  • (PMID = 19918923.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / N01 CA004919; United States / NCI NIH HHS / CA / CA37981; United States / NCI NIH HHS / CA / CA58416; United States / NCI NIH HHS / CA / N01 CA035176; United States / NCI NIH HHS / CA / CA45560; United States / NCI NIH HHS / CA / U10 CA032102-30; United States / NCI NIH HHS / CA / CA35178; United States / NCI NIH HHS / CA / CA45807; United States / NCI NIH HHS / CA / CA35261; United States / NCI NIH HHS / CA / U10 CA004919; United States / NCI NIH HHS / CA / N01 CA035431; United States / NCI NIH HHS / CA / CA22433; United States / NCI NIH HHS / CA / CA35431; United States / NCI NIH HHS / CA / U10 CA045560; United States / NCI NIH HHS / CA / CA20319; United States / NCI NIH HHS / CA / N01 CA032102; United States / NCI NIH HHS / CA / CA76426; United States / NCI NIH HHS / CA / U10 CA045808; United States / NCI NIH HHS / CA / N01 CA045807; United States / NCI NIH HHS / CA / CA45808; United States / NCI NIH HHS / CA / U10 CA074647; United States / NCI NIH HHS / CA / CA11083; United States / NCI NIH HHS / CA / CA58861; United States / NCI NIH HHS / CA / K24 CA097588; United States / NCI NIH HHS / CA / CA46282; United States / NCI NIH HHS / CA / U10 CA035261; United States / NCI NIH HHS / CA / U10 CA035178; United States / NCI NIH HHS / CA / U10 CA045461; United States / NCI NIH HHS / CA / U10 CA032102; United States / NCI NIH HHS / CA / U10 CA046282; United States / NCI NIH HHS / CA / CA32102; United States / NCI NIH HHS / CA / CA38926; United States / NCI NIH HHS / CA / N01 CA035178; United States / NCI NIH HHS / CA / N01 CA038926; United States / NCI NIH HHS / CA / CA032102-30; United States / NCI NIH HHS / CA / CA45461; United States / NCI NIH HHS / CA / U10 CA067575; United States / NCI NIH HHS / CA / CA74647; United States / NCI NIH HHS / CA / U10 CA020319; United States / NCI NIH HHS / CA / U10 CA038926; United States / NCI NIH HHS / CA / CA35176; United States / NCI NIH HHS / CA / U10 CA035431; United States / NCI NIH HHS / CA / U10 CA011083; United States / NCI NIH HHS / CA / N01 CA067575; United States / NCI NIH HHS / CA / CA04919; United States / NCI NIH HHS / CA / U10 CA035176; United States / NCI NIH HHS / CA / CA67575; United States / NCI NIH HHS / CA / U10 CA045807; United States / NCI NIH HHS / CA / N01 CA045560
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 4Z8R6ORS6L / Thalidomide; 7GR28W0FJI / Dacarbazine; 85622-93-1 / temozolomide
  • [Other-IDs] NLM/ NIHMS151995; NLM/ PMC2811758
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38. Becker JC, Terheyden P, Kämpgen E, Wagner S, Neumann C, Schadendorf D, Steinmann A, Wittenberg G, Lieb W, Bröcker EB: Treatment of disseminated ocular melanoma with sequential fotemustine, interferon alpha, and interleukin 2. Br J Cancer; 2002 Oct 7;87(8):840-5
Hazardous Substances Data Bank. Fotemustine .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Treatment of disseminated ocular melanoma with sequential fotemustine, interferon alpha, and interleukin 2.
  • Malignant melanoma of the uvea is remarkable for purely haematogenous dissemination and its tendency to metastasise to the liver.
  • Although the liver is involved in up to 95% of patients, 50% of these also develop extrahepatic metastases, most often in the lungs, bone, skin, and brain.
  • The only effective treatments reported to date relied on hepatic arterial chemoembolisation or -perfusion.
  • The objective of this study was to establish a therapy protocol addressing patients with both sole liver involvement and systemic disease.
  • Forty-eight patients with metastatic ocular melanoma received fotemustine 100 mg m(-2) either as 60-min infusion into the hepatic artery or as 15-min infusion via a peripheral vein, depending on the metastatic sites involved, i.e., restriction to the liver or hepatic together with extrahepatic disease.
  • For the first treatment cycle this infusion was repeated after one week.
  • Of note, this overall survival is much longer than that repeatedly reported for stage IV uveal melanoma not treated with fotemustine, suggesting a therapeutic activity of this cytostatic drug even after systemic administration.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Liver Neoplasms / drug therapy. Melanoma / drug therapy. Uveal Neoplasms / drug therapy
  • [MeSH-minor] Chemoembolization, Therapeutic. Combined Modality Therapy. Female. Hepatic Artery. Humans. Immunotherapy. Infusions, Intra-Arterial. Interferon-alpha / administration & dosage. Interleukin-2 / administration & dosage. Male. Middle Aged. Nitrosourea Compounds / administration & dosage. Organophosphorus Compounds / administration & dosage. Prospective Studies. Survival Rate. Treatment Outcome

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  • [Copyright] Copyright 2002 Cancer Research UK
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  • (PMID = 12373596.001).
  • [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; Journal Article
  • [Publication-country] Scotland
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Interleukin-2; 0 / Nitrosourea Compounds; 0 / Organophosphorus Compounds; GQ7JL9P5I2 / fotemustine
  • [Other-IDs] NLM/ PMC2376169
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39. Unger JM, Flaherty LE, Liu PY, Albain KS, Sondak VK: Gender and other survival predictors in patients with metastatic melanoma on Southwest Oncology Group trials. Cancer; 2001 Mar 15;91(6):1148-55
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Gender and other survival predictors in patients with metastatic melanoma on Southwest Oncology Group trials.
  • BACKGROUND: Some studies have suggested that women with metastatic malignant melanoma have a better survival rate than men.
  • However, little is known about the effect of gender on survival in combination with other clinical variables and treatment variables.
  • Thus, an analysis of 813 eligible patients from 15 consecutive Southwest Oncology Group (SWOG) Phase II or III trials evaluating chemotherapy or chemoimmunotherapy for metastatic melanoma was performed.
  • CONCLUSIONS: The current study found that performance status, OSM, and type of visceral involvement were independent predictors of survival in patients with metastic malignant melanoma and should be used as stratification factors in future Phase III trials.
  • However, the current study also found that gender did not appear to be a significant independent predictor of survival for this stage of disease.
  • The study concluded that further investigation of the biologic differences at early stage diagnosis should be undertaken to determine whether women truly have a different pace of disease progression and a different metastatic pattern.
  • [MeSH-major] Melanoma / pathology. Skin Neoplasms / pathology

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  • [Copyright] Copyright 2001 American Cancer Society.
  • (PMID = 11267960.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA14028; United States / NCI NIH HHS / CA / CA27057; United States / NCI NIH HHS / CA / CA32102; United States / NCI NIH HHS / CA / CA38926; United States / NCI NIH HHS / CA / CA46282
  • [Publication-type] Journal Article; Meta-Analysis; Multicenter Study; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
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40. Glaspy J, Atkins MB, Richards JM, Agarwala SS, O'Day S, Knight RD, Jungnelius JU, Bedikian AY: Results of a multicenter, randomized, double-blind, dose-evaluating phase 2/3 study of lenalidomide in the treatment of metastatic malignant melanoma. Cancer; 2009 Nov 15;115(22):5228-36
Hazardous Substances Data Bank. THALIDOMIDE .

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  • [Title] Results of a multicenter, randomized, double-blind, dose-evaluating phase 2/3 study of lenalidomide in the treatment of metastatic malignant melanoma.
  • BACKGROUND: There are currently no systemic treatments for stage IV melanoma, which have been proven in randomized trials to benefit overall survival (OS).
  • Lenalidomide has efficacy against melanoma in animal models and safety in phase 1 trials.
  • The authors reported the results of a phase 2/3 study comparing the safety and efficacy of 2 doses of lenalidomide in patients with relapsed metastatic melanoma disease refractory to previous treatment with dacarbazine, temozolomide, interleukin-2, or interferon-alpha.
  • Tumor response, time to progression, and OS were evaluated.
  • Treatment continued until disease progression or unacceptable adverse events.
  • RESULTS: No significant differences in response rate, OS, or time to progression were observed between lenalidomide 25 mg versus 5 mg (overall response rate: 5.5% vs 3.4%, P = .38; median OS: 6.8 months vs 7.2 months, P = .71; and median time to progression: 2.2 months vs 1.9 months, P = .24).
  • Treatment-related serious adverse events were seen in 39.0% of patients at the 25 mg dose and 35.4% of patients at the 5 mg dose.
  • CONCLUSIONS: Despite the occurrence of treatment-related serious adverse events, approximately 80% of patients continued treatment.
  • The higher dose of lenalidomide did not improve response rate, time to progression, or OS of patients with relapsed/refractory stage IV melanoma.
  • A parallel placebo-controlled study has been conducted to further assess the efficacy of lenalidomide in stage IV melanoma patients.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Thalidomide / analogs & derivatives
  • [MeSH-minor] Double-Blind Method. Drug Administration Schedule. Female. Humans. Male. Middle Aged. Neoplasm Metastasis. Retreatment. Survival Analysis

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  • (PMID = 19728370.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; 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; 4Z8R6ORS6L / Thalidomide; F0P408N6V4 / lenalidomide
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41. Weber J, Sondak VK, Scotland R, Phillip R, Wang F, Rubio V, Stuge TB, Groshen SG, Gee C, Jeffery GG, Sian S, Lee PP: Granulocyte-macrophage-colony-stimulating factor added to a multipeptide vaccine for resected Stage II melanoma. Cancer; 2003 Jan 1;97(1):186-200
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] Granulocyte-macrophage-colony-stimulating factor added to a multipeptide vaccine for resected Stage II melanoma.
  • BACKGROUND: Forty-eight patients with resected Stages IIA and IIB melanoma were immunized with two tumor antigen epitope peptides derived from gp100(209-217) (210M) (IMDQVPSFV) and tyrosinase(368-376) (370D) (YMDGTMSQV) emulsified with incomplete Freund's adjuvant (IFA).
  • Time to recurrence and survival were secondary end points.
  • A leukapheresis to obtain peripheral blood mononuclear cells for immune analyses and skin testing with peptides and recall reagents was performed before and after eight vaccinations.
  • Seventeen of the 40 patients for whom posttreatment skin tests were performed developed a positive skin test response to the gp100 peptide, but only 1 of the 40 patients developed a positive skin test response to tyrosinase.
  • CONCLUSION: These data suggest a significant number of patients with resected melanoma mount an antigen-specific immune response against a peptide vaccine.
  • [MeSH-major] Cancer Vaccines / therapeutic use. Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Antibodies, Neoplasm / immunology. Antibody Formation. Cytokines / immunology. Drug Therapy, Combination. Enzyme-Linked Immunosorbent Assay. Female. Humans. Male. Membrane Glycoproteins / immunology. Middle Aged. Monophenol Monooxygenase / immunology. Neoplasm Proteins / immunology. Neoplasm Staging. Oligopeptides / immunology. T-Lymphocytes / immunology. Vaccination. gp100 Melanoma Antigen

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  • [Copyright] Copyright 2003 American Cancer Society.
  • (PMID = 12491520.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / 5P30 CA 14089; United States / NCI NIH HHS / CA / R01 CA 090809
  • [Publication-type] Clinical Trial; Comparative Study; 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 / Antibodies, Neoplasm; 0 / Cancer Vaccines; 0 / Cytokines; 0 / Membrane Glycoproteins; 0 / Neoplasm Proteins; 0 / Oligopeptides; 0 / PMEL protein, human; 0 / gp100 Melanoma Antigen; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor; EC 1.14.18.1 / Monophenol Monooxygenase
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42. Pehamberger H: Perspectives of pegylated interferon use in dermatological oncology. Recent Results Cancer Res; 2002;160:158-64
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  • In dermato-oncology, IFNs have been used primarily in melanoma, but also in nonmelanoma skin cancer, such as squamous and basal cell carcinomas, Kaposi sarcomas and lymphomas.
  • Trials with IFNs have been performed in patients with melanoma in an adjuvant setting (stage II and III) and in metastatic disease (stage IV).
  • While the response rates with IFNs as single agents in stage IV disease usually do not exceed 15%, the use of adjuvant IFNs has been claimed to increase disease-free survival (stage II), or even overall survival (stage III), in low- or high-dose regimens, respectively; the latter, however, involved numerous side-effects and were beset with lack of compliance and acceptance, as well as being very costly.
  • Pharmacogenetic and pharmacodynamic data obtained in animal and in phase I studies have indicated that PEG-IFN injected once a week has the potential to be superior in efficacy to human IFN injected three times a week.
  • PEG-IFN is currently being evaluated for the treatment of CHC, renal cell carcinoma, chronic myelogenous leukaemia, and malignant melanoma, the last in both stage IV and stage III disease.
  • [MeSH-major] Interferon-alpha / therapeutic use. Polyethylene Glycols / therapeutic use. Skin Neoplasms / drug therapy
  • [MeSH-minor] Humans. Recombinant Proteins. Treatment Outcome

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  • (PMID = 12079210.001).
  • [ISSN] 0080-0015
  • [Journal-full-title] Recent results in cancer research. Fortschritte der Krebsforschung. Progrès dans les recherches sur le cancer
  • [ISO-abbreviation] Recent Results Cancer Res.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Recombinant Proteins; 0 / peginterferon alfa-2a; 0 / peginterferon alfa-2b; 30IQX730WE / Polyethylene Glycols; 76543-88-9 / interferon alfa-2a; 99210-65-8 / interferon alfa-2b
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