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1. Kefford RF, Clingan PR, Brady B, Ballmer A, Morganti A, Hersey P: A randomized, double-blind, placebo-controlled study of high-dose bosentan in patients with stage IV metastatic melanoma receiving first-line dacarbazine chemotherapy. Mol Cancer; 2010 Mar 30;9:69
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  • [Title] A randomized, double-blind, placebo-controlled study of high-dose bosentan in patients with stage IV metastatic melanoma receiving first-line dacarbazine chemotherapy.
  • BACKGROUND: The endothelin system is implicated in the pathogenesis of melanoma.
  • We evaluated the effects of bosentan - a dual endothelin receptor antagonist - in patients receiving first-line dacarbazine therapy for stage IV metastatic cutaneous melanoma in a phase 2, proof-of-concept study.
  • RESULTS: Eligible patients had metastatic cutaneous melanoma naïve to chemotherapy or immunotherapy, no central nervous system involvement, and serum lactate dehydrogenase <1.5 x upper limit of normal.
  • Treatment comprised bosentan 500 mg twice daily or matching placebo, in addition to dacarbazine 1000 mg/m2 every three weeks.
  • Eighty patients were randomized (double-blind) and 38 in each group received study treatment.
  • Median time to tumor progression (primary endpoint) was not significantly different between the two groups (placebo, 2.8 months; bosentan, 1.6 months; bosentan/placebo hazard ratio, 1.144; 95% CI, 0.717-1.827; p = 0.5683).
  • Incidences of most adverse events and clinically relevant increases in hepatic transaminases were similar between treatment groups although hemoglobin decrease to >8 and < or = 10 g/dL and < or = 8 g/dL was more common in the bosentan group.
  • CONCLUSIONS: In patients receiving dacarbazine as first-line chemotherapy for metastatic melanoma, the addition of high-dose bosentan had no effect on time to tumor progression or other efficacy parameters.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Dacarbazine / administration & dosage. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Sulfonamides / administration & dosage

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  • (PMID = 20350333.001).
  • [ISSN] 1476-4598
  • [Journal-full-title] Molecular cancer
  • [ISO-abbreviation] Mol. Cancer
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT01009177
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Sulfonamides; 7GR28W0FJI / Dacarbazine; Q326023R30 / bosentan
  • [Other-IDs] NLM/ PMC2856553
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2. Singer M, Mutch MG: Anal melanoma. Clin Colon Rectal Surg; 2006 May;19(2):78-87
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  • [Title] Anal melanoma.
  • Anal melanoma is rare and aggressive malignancy.
  • Unlike cutaneous melanoma, anal melanoma has no known risk factors.
  • Surgical excision remains the cornerstone of therapy.
  • There are no long-term survivors of stage II or III disease; therefore, early diagnosis and treatment remain crucial.
  • Adjuvant chemotherapy, interferon, and radiation may offer some benefit.

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  • (PMID = 20011314.001).
  • [ISSN] 1530-9681
  • [Journal-full-title] Clinics in colon and rectal surgery
  • [ISO-abbreviation] Clin Colon Rectal Surg
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Other-IDs] NLM/ PMC2780102
  • [Keywords] NOTNLM ; Melanoma / abdominoperineal resection / anal / malignancy / wide local excision
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3. Dummer R, Hauschild A, Becker JC, Grob JJ, Schadendorf D, Tebbs V, Skalsky J, Kaehler KC, Moosbauer S, Clark R, Meng TC, Urosevic M: An exploratory study of systemic administration of the toll-like receptor-7 agonist 852A in patients with refractory metastatic melanoma. Clin Cancer Res; 2008 Feb 1;14(3):856-64
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  • [Title] An exploratory study of systemic administration of the toll-like receptor-7 agonist 852A in patients with refractory metastatic melanoma.
  • PURPOSE: A topical Toll-like receptor 7 (TLR7) agonist induces regression of cutaneous melanocytic neoplasms.
  • We explored antitumor activity of a systemically administered TLR7 agonist, 852A, in patients with metastatic melanoma.
  • EXPERIMENTAL DESIGN: We undertook a phase II, multicenter, open-label study in patients with chemotherapy-refractory metastatic melanoma.
  • Immune effects of 852A were monitored by measuring serum type I IFN and IP-10 together with assessment of immune cell markers in peripheral blood.
  • Thirteen patients completed the initial 12-week treatment cycle, with two discontinuing for adverse events considered to be possibly related to study drug.
  • One patient had a partial remission after two treatment cycles, but progressed during the third.
  • Serum type I IFN and IP-10 increased in most patients on 852A administration.
  • Serum type I IFN increases were greater after dosing with 852A 0.9 mg/m(2) than after 0.6 mg/m(2) (P = 0.009).
  • The maximal increase in IP-10 compared with baseline correlated with the maximal increase in type I IFN (P = 0.003).
  • CONCLUSION: Intravenous 852A was well tolerated and induced systemic immune activation that eventually resulted in prolonged disease stabilization in some patients with stage IV metastatic melanoma who had failed chemotherapy.
  • [MeSH-major] Melanoma / drug therapy. Quinolines / therapeutic use. Skin Neoplasms / drug therapy. Sulfonamides / therapeutic use. Toll-Like Receptor 7 / agonists
  • [MeSH-minor] Adult. Chemokine CXCL10 / blood. Cytokines / blood. Female. Humans. Interferon Type I / blood. Male. Monitoring, Immunologic. Patient Selection

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  • (PMID = 18245549.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / CXCL10 protein, human; 0 / Chemokine CXCL10; 0 / Cytokines; 0 / Interferon Type I; 0 / N-(4-(4-amino-2-ethyl-1H-imidazo(4,5c)quinolin-1-yl)butyl)methanesulfonamide; 0 / Quinolines; 0 / Sulfonamides; 0 / TLR7 protein, human; 0 / Toll-Like Receptor 7
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4. Ahn HJ, Na II, Park YH, Cho SY, Lee BC, Lee GH, Koh JS, Lee YS, Shim YS, Kim YK, Kang HJ, Ryoo BY, Yang SH: Role of adjuvant chemotherapy in malignant mucosal melanoma of the head and neck. Oral Oncol; 2010 Aug;46(8):607-11
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  • [Title] Role of adjuvant chemotherapy in malignant mucosal melanoma of the head and neck.
  • The objective of this study was to analyze the role of adjuvant chemotherapy and prognostic factors in malignant mucosal melanoma of the head and neck (HNMM).
  • Thirty-two patients with mucosal melanoma of the head and neck who received local treatment with or without adjuvant chemotherapy were reviewed.
  • Clinicopathologic parameters including anatomic sites, gender, age (60 vs.>60years), stage, level of invasion, p53 and MDM2 [murine double minute 2] expressions, performance status, and adjuvant chemotherapy were evaluated.
  • The patients' median age was 62years, and 16 (50%) received adjuvant chemotherapy.
  • Patients who received adjuvant chemotherapy had prolonged survival (p=0.002), which was also shown in the multivariate Cox regression model (HR, 0.24; p=0.014).
  • Our analysis suggests a significant role of adjuvant chemotherapy and different patterns of p53 and MDM2 expression in HNMM relative to cutaneous melanomas.
  • However, since this study is retrospective and observational, with a small sample size, further studies are needed to confirm the definitive role of adjuvant chemotherapy in the treatment of malignant mucosal melanoma of the head and neck.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Head and Neck Neoplasms / drug therapy. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Chemotherapy, Adjuvant / adverse effects. Chemotherapy, Adjuvant / methods. Female. Humans. Male. Middle Aged. Mouth Mucosa / pathology. Neoplasm Staging. Prognosis. Radiotherapy, Adjuvant / methods. Retrospective Studies. Survival Analysis

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  • [Copyright] Copyright 2010 Elsevier Ltd. All rights reserved.
  • (PMID = 20615750.001).
  • [ISSN] 1879-0593
  • [Journal-full-title] Oral oncology
  • [ISO-abbreviation] Oral Oncol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents
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5. Daud A, Valkov N, Centeno B, Derderian J, Sullivan P, Munster P, Urbas P, Deconti RC, Berghorn E, Liu Z, Hausheer F, Sullivan D: Phase II trial of karenitecin in patients with malignant melanoma: clinical and translational study. Clin Cancer Res; 2005 Apr 15;11(8):3009-16
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  • [Title] Phase II trial of karenitecin in patients with malignant melanoma: clinical and translational study.
  • PURPOSE: A phase II trial of the novel camptothecin karenitecin (BNP1350) was conducted to determine its efficacy and tolerability in patients with metastatic melanoma.
  • Patients were biopsied to determine topoisomerase expression at baseline and response to therapy.
  • PATIENTS AND METHODS: Eligible patients had metastatic melanoma with up to three prior chemotherapy and/or any number of immunotherapy regimens.
  • Treatment consisted of an i.v. infusion of 1 mg/m(2) karenitecin daily for 5 days with cycles repeated every 3 weeks.
  • Fine-needle aspiration biopsies were done before treatment and on day 3 to determine topoisomerase expression from patients' tumors.
  • Most patients (72%) had stage M1C disease and were previously exposed to chemotherapy (56%).
  • One patient had a complete response after 11 months of therapy.
  • CONCLUSION: Karenitecin was a well-tolerated investigational agent in this phase II study; side effects were generally mild and mostly hematologic.
  • Karenitecin has significant activity in metastatic melanoma.
  • Melanoma metastases express high levels of topoisomerase I.
  • We did not observe any compensatory increase in topoisomerase II upon treatment with karenitecin.
  • [MeSH-major] Camptothecin / analogs & derivatives. Melanoma / drug therapy
  • [MeSH-minor] Adult. Aged. Anemia / chemically induced. DNA Topoisomerases, Type I / metabolism. DNA Topoisomerases, Type II / metabolism. Fatigue / chemically induced. Female. HL-60 Cells. Humans. Male. Middle Aged. Nausea / chemically induced. Neutropenia / chemically induced. Survival Analysis. Thrombocytopenia / chemically induced. Treatment Outcome. Vomiting / chemically induced

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  • (PMID = 15837755.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA 82533
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 24R60NVC41 / cositecan; EC 5.99.1.2 / DNA Topoisomerases, Type I; EC 5.99.1.3 / DNA Topoisomerases, Type II; XT3Z54Z28A / Camptothecin
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6. Petrella T, Quirt I, Verma S, Haynes AE, Charette M, Bak K, Members of the Melanoma Disease Site Group of Cancer Care Ontario's Program in Evidence-Based Care: Single-agent interleukin-2 in the treatment of metastatic melanoma. Curr Oncol; 2007 Feb;14(1):21-6
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  • [Title] Single-agent interleukin-2 in the treatment of metastatic melanoma.
  • QUESTIONS: What is the role of single-agent interleukin-2 (il-2) in the treatment of adults with metastatic melanoma?
  • If there is a role for single-agent il-2, what patient population can appropriately be considered for treatment?
  • PERSPECTIVES: Many agents have been investigated for antitumour activity in melanoma, but few have shown promising response rates.
  • Early detection, appropriate surgery, and adjuvant therapy have all improved outcomes, but approximately one third of patients with early-stage disease will nevertheless develop metastases.
  • A number of randomized trials and many phase ii trials investigating single-agent il-2 suggest that this systemic treatment produces durable responses in melanoma patients.
  • Given the dismal survival of patients with meta-static melanoma and the limited availability of effective treatments, the Melanoma Disease Site Group (dsg) of Cancer Care Ontario's Program in Evidence-Based Care (pebc) felt that the durable responses seen with il-2 treatment warranted closer examination.
  • METHODOLOGY: A systematic review was developed, and clinical recommendations relevant to patients in Ontario were drafted.
  • The practice guideline report was reviewed and approved by the Melanoma dsg, which comprises medical oncologists, surgeons, and dermatologists.
  • PRACTICE GUIDELINE: No studies have compared il-2 to the current standard of care-dacarbazine (dtic)-or to placebo in the treatment of metastatic melanoma.
  • After reviewing and weighing the evidence that does exist, the opinion of the Melanoma dsg is that high-dose il-2 is a reasonable treatment option for a select group of patients with metastatic melanoma: Patients should have a good performance status (Eastern Cooperative Oncology Group 0-1) and a normal lactate dehydrogenase level.Patients should have fewer than three organs involved or have cutaneous and/or subcutaneous metastases only, and no evidence of central nervous system metastases should be present.In this select group of patients, il-2 treatment can produce durable complete remissions.
  • High-dose il-2 delivery is recommended to be done in a tertiary-care facility by staff trained in the provision of this treatment and with appropriate monitoring.
  • To facilitate treatment and to develop expertise in this therapeutic modality, the dsg recommends that high-dose il-2 programs be established in one or two centres in Ontario.
  • QUALIFYING STATEMENTS: High-dose il-2 has response rates that are similar to those seen with standard chemotherapy.
  • However, unlike chemotherapy, il-2 demonstrates low but durable complete response rates that may lead to years of benefit for patients with metastatic melanoma.
  • In these select patients, high dose il-2 may be considered for first-line therapy.
  • The lack of large randomized trials comparing il-2 to dtic or other chemotherapy means that recommendations for this guideline are based largely on phase ii data and limited phase iii data.
  • Interleukin-2 is currently widely used in the United States, and it is an approved therapy in both Canada and the United States.

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  • (PMID = 17576460.001).
  • [ISSN] 1198-0052
  • [Journal-full-title] Current oncology (Toronto, Ont.)
  • [ISO-abbreviation] Curr Oncol
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Canada
  • [Other-IDs] NLM/ PMC1891192
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7. Tarhini AA, Kirkwood JM, Tawbi H, Gooding WE, Islam MF, Agarwala SS: Safety and efficacy of arsenic trioxide for patients with advanced metastatic melanoma. Cancer; 2008 Mar 1;112(5):1131-8
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  • [Title] Safety and efficacy of arsenic trioxide for patients with advanced metastatic melanoma.
  • BACKGROUND: Arsenic trioxide (ATO) cytotoxicity and apoptosis induction has been demonstrated with numerous cancer cell lines, including human melanoma.
  • METHODS: A second-line, phase 2, single-arm study of ATO was conducted in patients with inoperable American Joint Committee on Cancer (AJCC) stage IV melanoma.
  • One cycle consisted of a loading dose of 0.32 mg/kg/day for 4 days in Week 1, followed by 0.25 mg/kg/day twice per week for 6 weeks, followed by 1 week of rest, at which time response assessment was performed.
  • All had stage IV melanoma including M1a (2 patients), M1b (6 patients), and M1c (13 patients) disease.
  • One patient had metastatic choroidal melanoma and 20 patients had cutaneous melanoma.
  • Twenty patients had received prior therapy.
  • Possible treatment-related grade 3 of 4 toxicities (using the National Cancer Institute Common Toxicity Criteria) included 1 case of idiopathic thrombocytopenic purpura and 1 case of elevated lactate dehydrogenase.
  • Four patients did not complete the first cycle of therapy and were not evaluable for response.
  • Among 17 evaluable patients, 1 patient (6%; 95% confidence interval [95% CI], 0-29%) achieved a partial response lasting 7 months, and 10 patients (59%) had disease stabilization after at least 1 cycle, but all eventually developed disease progression.
  • The median time to disease progression was 17 weeks (95% CI, 11-38 weeks) and the median survival was 13 months (95% CI, 12-26 months).
  • CONCLUSIONS: ATO as tested in the current trial was found to be well tolerated and had limited activity in patients with metastatic melanoma.
  • The application of this agent in combination with either chemotherapy or agents that target recognized critical signaling and antiapoptotic pathways of melanoma has not yet been performed.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Antineoplastic Agents / toxicity. Arsenicals / therapeutic use. Choroid Neoplasms / drug therapy. Melanoma / drug therapy. Oxides / therapeutic use. Oxides / toxicity. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Drug Administration Schedule. Female. Humans. Male. Middle Aged

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  • [ErratumIn] Cancer. 2013 Feb 15;119(4):924
  • (PMID = 18286511.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / P50CA121973
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Arsenicals; 0 / Oxides; S7V92P67HO / arsenic trioxide
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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. Wierzbicka-Hainaut E, Sassolas B, Mourey L, Guillot B, Bedane C, Guillet G, Tourani JM: Temozolomide and cisplatin combination in naive patients with metastatic cutaneous melanoma: results of a phase II multicenter trial. Melanoma Res; 2010 Apr;20(2):141-6
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  • [Title] Temozolomide and cisplatin combination in naive patients with metastatic cutaneous melanoma: results of a phase II multicenter trial.
  • Temozolomide (TMZ) is a second-generation alkylating agent that has recently shown some efficacy in stage IV melanoma.
  • The purpose of this study was to test the efficacy and safety of combination therapy with TMZ and cisplatin (CDDP) in patients with metastatic melanoma.
  • Chemo-naive patients with metastatic cutaneous melanoma were included in a phase II study of combined therapy with TMZ (200 mg/m/day), days 1-5, and CDDP (75 mg/m/day) on day 1.
  • The treatment was given every 28 days, for up to six cycles.
  • Our results suggest that concurrent adjunction of CDDP to TMZ regimen increases toxicity according to this schedule and does not improve the outcome of stage IV melanoma.
  • The objective response rate is close to response rates observed with single-agent chemotherapy.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy

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  • (PMID = 20075758.001).
  • [ISSN] 1473-5636
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] England
  • [Chemical-registry-number] 7GR28W0FJI / Dacarbazine; 85622-93-1 / temozolomide; Q20Q21Q62J / Cisplatin
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10. 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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11. Homsi J, Bedikian AY, Kim KB, Papadopoulos NE, Hwu WJ, Mahoney SL, Hwu P: Phase 2 open-label study of weekly docosahexaenoic acid-paclitaxel in cutaneous and mucosal metastatic melanoma patients. Melanoma Res; 2009 Aug;19(4):238-42
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  • [Title] Phase 2 open-label study of weekly docosahexaenoic acid-paclitaxel in cutaneous and mucosal metastatic melanoma patients.
  • Docosahexaenoic acid (DHA)-paclitaxel has a unique pharmacokinetic profile that allows high concentrations of paclitaxel to be delivered to melanoma cells for prolonged periods compared with paclitaxel.
  • We investigated the response rate and safety of weekly DHA-paclitaxel in metastatic melanoma patients.
  • We enrolled chemotherapy-naive patients with metastatic nonchoroidal melanoma using the two-stage Fleming design.
  • At least one response was needed in the first stage to proceed to the second stage.
  • DHA-paclitaxel (500 mg/m/week by 1-h intravenous infusion) was administered for 5 weeks every 6-week cycle until disease progression, intolerable toxicity, or treatment refusal.
  • The median number of treatment cycles was 2 (range: 1-6 cycles).
  • Neutropenia (10%) and musculoskeletal pain (10%) were the most common grade 3 and 4 toxicities, and fatigue (73%), skin rash (70%), and diarrhea (60%) were the most common side effects.
  • As a single-agent therapy, DHA-paclitaxel was well tolerated in metastatic melanoma patients.
  • Its efficacy as a first-line therapy for metastatic melanoma does not exceed that seen with other single-agent chemotherapies such as dacarbazine.
  • Further evaluation of DHA-paclitaxel in combination with other chemotherapy or targeted agents could be considered.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Melanoma / drug therapy. Paclitaxel / analogs & derivatives. Skin Neoplasms / drug therapy

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  • (PMID = 19521262.001).
  • [ISSN] 1473-5636
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / docosahexaenoyl-paclitaxel; P88XT4IS4D / Paclitaxel
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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. 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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14. 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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15. Goyal A, Evans WD, Mansel RE: Isolated hyperthermic chemotherapy perfusion for limb melanoma is a safe procedure. J Clin Oncol; 2004 Jul 15;22(14_suppl):7538

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Isolated hyperthermic chemotherapy perfusion for limb melanoma is a safe procedure.
  • : 7538 Background: Isolated limb perfusion(ILP) delivers high dose of chemotherapeutic agent to an extremity with multiple in-transit lesions from cutaneous melanoma.
  • METHODS: 53 perfusions were performed using melphalan, 1.5-2mg/kg (13 prophylactic, 40 therapeutic) and 3 using melphalan in combination with other chemotherapeutic agents (all therapeutic).
  • 75% of the patients had MD Anderson stage III disease.
  • Bone marrow depression was encountered in 59%(33/56) patients: WHO grade I in 8, grade II in 11, grade III in 8, and grade IV in 6.
  • Overall 5-year survival rate was 49% for therapeutic perfusion and 100% for prophylactic perfusion.
  • CONCLUSION: Therapeutic ILP is a suitable treatment for in-transit metastases not amenable to surgery and confined to a limb, since amputation provides no advantage in terms of survival.

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  • (PMID = 28014919.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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16. Tarhini AA, Christensen S, Frankel P, Margolin K, Ruel C, Shipe-Spotloe J, DeMark M, Kirkwood JM: Phase II study of aflibercept (VEGF trap) in recurrent inoperable stage III or stage IV melanoma of cutaneous or ocular origin. J Clin Oncol; 2009 May 20;27(15_suppl):9028

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of aflibercept (VEGF trap) in recurrent inoperable stage III or stage IV melanoma of cutaneous or ocular origin.
  • METHODS: Phase II study of aflibercept in patients with inoperable stage III or IV melanoma who had received no prior chemotherapy or hormonal therapy.
  • A 2-stage design was adopted focusing upon response rate (RECIST) and 4-month PFS rate.
  • First stage accrual of 21 patients was specified, while final accrual of 41 is planned, with adequate response/4 month PFSR.
  • All had AJCC stage IV melanoma (3M1a, 3M1b, 21M1c).
  • Nine patients had primary ocular melanoma, 16 cutaneous and 2 unknown primary site.
  • Grade 3/4 toxicities included cerebral ischemia (1 patient; 4%), confusion (1; 4%), thrombocytopenia (1; 4%), hypertension (7; 26%), hypotension (1; 4%), left ventricular diastolic dysfunction (1; 4%), fatigue (1; 4%), proteinuria (4; 15%), extraocular muscle paresis (1; 4%), renal failure (1; 4%), back pain (1; 4%), headache (1; 4%).
  • Interim analysis was conducted after the first 21 patients (stage 1).
  • Eight (1 M1a, 1M1b, 6M1c; 4 ocular, 3 cutaneous, 1 unknown primary) of the first 21 patients had at least 4 months of PFS (10 out of 27; 2 additional patients with cutaneous melanoma had SD: 1M1a and 1M1c).
  • One patient (23<sup>rd</sup>; cutaneous, M1c) had a confirmed complete remission.
  • Four patients were taken off study prior to response evaluation for toxicity (3) or treatment refusal (1).
  • CONCLUSIONS: Aflibercept can be administered with acceptable toxicity, and exhibits promising antitumor efficacy against advanced melanoma.
  • This study continues second stage accrual with anticipated closure before June 2009.

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  • (PMID = 27962095.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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17. Patel S, Bedikian A, Kim K, Papadopoulos N, Hwu P, Vardeleon A, Prieto V, Bar Eli M, Bronstein Y, Bassett R Jr: A phase II study of gefitinib in patients with metastatic melanoma. J Clin Oncol; 2009 May 20;27(15_suppl):9057

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II study of gefitinib in patients with metastatic melanoma.
  • : 9057 Background: Gefitinib is an inhibitor of epidermal growth factor receptor (EGFR), which is frequently expressed on both choroidal and non-choroidal melanoma cells.
  • We evaluated the clinical efficacy of gefitinib in patients (pts) with metastatic melanoma.
  • METHODS: Pts with stage IV or unresectable or recurrent stage III melanoma and Zubrod performance status of 0 to 2 were eligible.
  • For non-choroidal melanoma, pts must have received systemic cytotoxic therapy, but no more than 2 regimens; for choroidal melanoma, pts could be either chemo-naïve or have received up to 2 systemic cytotoxic therapies.
  • Ten patients with cutaneous disease were also consented for paired biopsies and blood collection for correlative studies at baseline and after 3 weeks of treatment.
  • The median number of prior systemic treatments was 1.
  • Forty-one pts (79%) had stage M1c disease.
  • There were no drug-related grade 4 or 5 adverse events (AEs), and fatigue was the only grade 3 AEs in >5% of the patients.
  • There were 2 (4%) partial responses, including a pt with metastatic choroidal melanoma, and 13 pts (26%) had disease stabilization.
  • Median time to progression was 6 weeks, and median overall survival was 4.6 months.
  • Among 7 pts with sufficient tissue on paired biopsies, there were no notable trends in the changes of the expression of pERK1/2, pAKT, or pPAK1 with treatment.
  • Additionally, no trends were identified in serum VEGF or IL-8 levels after treatment.
  • CONCLUSIONS: Gefitinib was well tolerated, but had minimal clinical efficacy as a single-agent therapy for metastatic melanoma of cutaneous origin.
  • There were no consistent changes in the expressions of downstream kinase proteins with gefitinib treatment.

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  • (PMID = 27962131.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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18. Sondak VK: Adjuvant therapy for melanoma. Cancer J; 2001 Jul-Aug;7 Suppl 1:S24-7
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  • [Title] Adjuvant therapy for melanoma.
  • Patients with deep primaries (> or = 4 mm) or regional lymph node involvement often require adjuvant therapy in addition to surgery to successfully treat melanoma.
  • Randomized trials of IFN-alpha adjuvant therapy have demonstrated statistically significant improvements in disease-free and overall survival rates, leading to approval by the United States Food and Drug Administration of the use of 1 year of intensive IFN-alpha2b following surgical resection of high-risk disease.
  • A study comparing high-dose IFN with the ganglioside vaccine GMK was terminated early when the Data Safety Monitoring Committee concluded that the high-dose IFN treatment arm was associated with highly significantly improved relapse-free and overall survival.
  • Studies of IFN-alpha in stage I and II melanoma are reviewed.
  • In addition to adjuvant therapy with IFN-alpha, various other treatment strategies appear promising.
  • Adjuvant vaccine therapy may be useful for treatment of cutaneous melanoma.
  • Polyvalent melanoma vaccines are discussed as a potential adjuvant therapy.
  • Finally, nonrandomized preliminary studies suggest that postoperative radiation to the neck or axilla after radical lymph node dissection may decrease regional recurrence rates in node-positive patients, supporting the selective use of radiation therapy for melanoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Melanoma / drug therapy. Melanoma / radiotherapy. Skin Neoplasms / drug therapy. Skin Neoplasms / radiotherapy
  • [MeSH-minor] Cancer Vaccines / therapeutic use. Chemotherapy, Adjuvant. Humans. Interferon-alpha / therapeutic use. Interferon-gamma / therapeutic use. Radiotherapy, Adjuvant

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  • (PMID = 11504282.001).
  • [ISSN] 1528-9117
  • [Journal-full-title] Cancer journal (Sudbury, Mass.)
  • [ISO-abbreviation] Cancer J
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Cancer Vaccines; 0 / Interferon-alpha; 82115-62-6 / Interferon-gamma
  • [Number-of-references] 35
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19. Petrescu I, Condrea C, Alexandru A, Dumitrescu D, Simion G, Severin E, Albu C, Albu D: Diagnosis and treatment protocols of cutaneous melanoma: latest approach 2010. Chirurgia (Bucur); 2010 Sep-Oct;105(5):637-43
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  • [Title] Diagnosis and treatment protocols of cutaneous melanoma: latest approach 2010.
  • Cutaneous melanoma is the most aggressive skin malignancies with increasing rate of incidence in the latest decades.
  • New imaging technique plays an important role in melanoma management: dermoscopy and computer dermoscopy, ultrasound, MRI, CT, PET and PET/CT.
  • Due to the dermoscopy and lesion diagnosis in early stages the increasing number of curative melanoma are registered.
  • Serological biomarkers proved to be a necessary investigation for melanoma diagnosis, follow-up and treatment response.
  • Current TNM melanoma staging is based on AJCC classification since 2001 witch includes new elements like histopathologic ulceration in stage I and II and lymph node micro- and macrometastases in stage III.
  • Treatment protocols include surgical tumor excision with only 1-2 cm safety margins and radical lymphadenectomy is performed after positive sentinel lymph node biopsy.
  • The adjuvant treatment in advanced stages including chemotherapy, unspecific immunotherapy and interferon offers poor results regarding free disease terms rate of survival.
  • The advanced therapeutic procedure like golden nanospheres and gene therapy are recently studied and represent an alternative for future treatment of melanoma.
  • Follow-up protocols have a great importance for detection of the melanoma recurrences and include clinical, serological and imaging evaluation.
  • Despite all new knowledge and technological support the advanced stage melanoma management still remain an unsolved problem.
  • [MeSH-major] Melanoma / diagnosis. Melanoma / therapy. Skin Neoplasms / diagnosis. Skin Neoplasms / therapy
  • [MeSH-minor] Chemotherapy, Adjuvant. Diagnosis, Differential. Early Detection of Cancer. Humans. Incidence. Medical Oncology / trends. Neoplasm Staging. Risk Factors. Romania / epidemiology. Sentinel Lymph Node Biopsy. Survival Rate. Treatment Outcome

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  • (PMID = 21141087.001).
  • [ISSN] 1221-9118
  • [Journal-full-title] Chirurgia (Bucharest, Romania : 1990)
  • [ISO-abbreviation] Chirurgia (Bucur)
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] Romania
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20. 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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21. Daryanani D, Plukker JT, de Jong MA, Haaxma-Reiche H, Nap R, Kuiper H, Hoekstra HJ: Increased incidence of brain metastases in cutaneous head and neck melanoma. Melanoma Res; 2005 Apr;15(2):119-24
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  • [Title] Increased incidence of brain metastases in cutaneous head and neck melanoma.
  • The incidence of cutaneous melanoma is increasing, and 10-20% of these melanomas are located in the head and neck region.
  • During the period 1965-2000, 324 patients [152 females (47%), 172 males (53%)] were treated for cutaneous melanoma of the head and neck.
  • The patients were staged according to the 2002 American Joint Committee on Cancer (AJCC) melanoma staging system.
  • Twenty six (8%) head and neck patients, compared with 5.2% of extremity/truncal patients, developed brain metastases (confidence interval, 0.058-0.108; P<0.05).
  • The 26 head and neck patients (four Stage I, 10 Stage II and 12 Stage III) had a median age of 46 years (range, 16-79 years) and developed brain metastases after a median follow-up of 24 months (range, 4-75 months).
  • The patients were treated with steroids, surgery, radiation, chemotherapy, or a combination of these.
  • Risk factors identified for the development of brain metastases from head and neck melanoma were a younger age, male gender, Breslow thickness greater than 4 mm and increased mitotic rate.
  • The incidence of brain metastases is significantly higher in patients with cutaneous melanoma of the head and neck (8%) compared with those with extremity/truncal melanoma (5.2%).
  • The prognosis is still extremely poor with current therapies.
  • [MeSH-major] Brain Neoplasms / secondary. Head and Neck Neoplasms / pathology. Melanoma / secondary. Skin Neoplasms / pathology


22. Rossi CR, Foletto M, Mocellin S, Pilati PL, Campana L, Rubello D, Lise M: TNF-based limb perfusion for cutaneous melanoma in transit metastases: suggestions for modification of the perfusional schedule. J Exp Clin Cancer Res; 2003 Dec;22(4 Suppl):103-7
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  • [Title] TNF-based limb perfusion for cutaneous melanoma in transit metastases: suggestions for modification of the perfusional schedule.
  • Isolated limb perfusion (ILP) is currently considered the standard treatment for melanoma patients with extensive in-transit disease, and L-PAM, combined or not with TNF, represents the most active drug.
  • Thirty-seven stage III patients underwent TNF-based limb perfusion, 22 with bulky disease, 15 with recurrences after perfusion with L-PAM.
  • Ten patients were enrolled in a phase I-II study and treated with escalating doses of TNF (0.5-3 mg).
  • [MeSH-major] Chemotherapy, Cancer, Regional Perfusion. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Tumor Necrosis Factor-alpha / administration & dosage
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Agents, Alkylating / therapeutic use. Dose-Response Relationship, Drug. Extremities / pathology. Female. Humans. Hyperthermia, Induced. Male. Melphalan / therapeutic use. Middle Aged. Neoplasm Recurrence, Local / drug therapy. Time Factors. Treatment Outcome

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  • [ErratumIn] J Exp Clin Cancer Res. 2006 Sep;25(3):preceding table of contents. Ribello, D [corrected to Rubello, D]
  • (PMID = 16767915.001).
  • [ISSN] 0392-9078
  • [Journal-full-title] Journal of experimental & clinical cancer research : CR
  • [ISO-abbreviation] J. Exp. Clin. Cancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; 0 / Tumor Necrosis Factor-alpha; Q41OR9510P / Melphalan
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23. 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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  • [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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24. Elias EG, Zapas JL, McCarron EC, Beam SL, Hasskamp JH, Culpepper WJ: Sequential administration of GM-CSF (Sargramostim) and IL-2 +/- autologous vaccine as adjuvant therapy in cutaneous melanoma: an interim report of a phase II clinical trial. Cancer Biother Radiopharm; 2008 Jun;23(3):285-91
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  • [Title] Sequential administration of GM-CSF (Sargramostim) and IL-2 +/- autologous vaccine as adjuvant therapy in cutaneous melanoma: an interim report of a phase II clinical trial.
  • Granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2) are 2 cytokines with distinct mechanisms of action that complement one another in the adjuvant management of melanoma.
  • Forty-five patients with high-risk melanoma were enrolled in an open-label, single-arm, phase II clinical trial to examine the safety, tolerability, and effectiveness of this combination.
  • After potentially curative surgery, each patient received 12 months of GM-CSF 125 microg/m2/d subcutaneously (SC) for 14 days followed by IL-2, 9 million IU/m2/d SC for 4 days (given every other cycle from months 7-12), followed by 10 days of no treatment.
  • In addition, patients who had tumors yielding an adequate number of live cells received autologous melanoma vaccines.
  • Thirty-two patients are alive: 9 of 13 with stage IV resected melanoma, 16 of 25 with stage III disease, and 7 of 7 with stage II disease.
  • Adjuvant use of sequential GM-CSF and IL-2 +/- autologous vaccine was well tolerated with good patient compliance and seemed to benefit high-risk patients with surgically resected melanoma.
  • [MeSH-major] Cancer Vaccines / therapeutic use. Granulocyte-Macrophage Colony-Stimulating Factor / administration & dosage. Interleukin-2 / genetics. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Combined Modality Therapy. Disease-Free Survival. Female. Humans. Male. Middle Aged. Recombinant Proteins

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  • (PMID = 18593361.001).
  • [ISSN] 1557-8852
  • [Journal-full-title] Cancer biotherapy & radiopharmaceuticals
  • [ISO-abbreviation] Cancer Biother. Radiopharm.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Cancer Vaccines; 0 / Interleukin-2; 0 / Recombinant Proteins; 123774-72-1 / sargramostim; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor
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25. Stadler R, Luger T, Bieber T, Köhler U, Linse R, Technau K, Schubert R, Schroth K, Vakilzadeh F, Volkenandt M, Gollnick H, Von Eick H, Thoren F, Strannegård O: Long-term survival benefit after adjuvant treatment of cutaneous melanoma with dacarbazine and low dose natural interferon alpha: A controlled, randomised multicentre trial. Acta Oncol; 2006;45(4):389-99
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  • [Title] Long-term survival benefit after adjuvant treatment of cutaneous melanoma with dacarbazine and low dose natural interferon alpha: A controlled, randomised multicentre trial.
  • In a prospective, controlled, randomised, multicentre study 252 patients with totally resected cutaneous melanoma (248 in stage II-III and 4 in stage IV) were either treated with two doses of dacarbazine (DTIC) followed by a 6-month treatment with 3 MU thrice weekly of highly purified natural interferon-alpha (n = 128; arm A) or received no adjuvant treatment (n = 124; arm B).
  • Treatment was well tolerated.
  • After a median follow-up of 8.5 years ITT analysis showed that the difference in survival was statistically significant with respect to melanoma-related deaths (HR = 0.65, CI = 0.46-0.97, p = 0.022) and close to significance with respect to overall survival (HR 0.71, CI 0.49-1.00, p = 0.052).
  • The risk reduction of melanoma-associated death, calculated by Cox proportional hazards modelling, after adjusting for identified predictive variables, was almost 50% (p = 0.002).
  • The overall efficacy of the treatment appeared to be mainly attributable to effects observed in patients with deep and/or metastasizing tumours (HR 0.60, CI 0.40-0.90, p = 0.013).
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Melanoma / mortality. Skin Neoplasms / mortality
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Chemotherapy, Adjuvant. Dacarbazine / administration & dosage. Female. Humans. Interferon-alpha / administration & dosage. Male. Middle Aged. Neoplasm Recurrence, Local / drug therapy. Neoplasm Recurrence, Local / mortality. Neoplasm Recurrence, Local / secondary. Neoplasm Staging. Prospective Studies. Survival Rate

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  • [CommentIn] Acta Oncol. 2006;45(4):369-72 [16760171.001]
  • (PMID = 16760174.001).
  • [ISSN] 0284-186X
  • [Journal-full-title] Acta oncologica (Stockholm, Sweden)
  • [ISO-abbreviation] Acta Oncol
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Norway
  • [Chemical-registry-number] 0 / Interferon-alpha; 7GR28W0FJI / Dacarbazine
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26. Romanini A, Manca G, Pellegrino D, Murr R, Sarti S, Bianchi F, Alsharif A, Orlandini C, Zucchi V, Castagna M, Gandini D, Salimbeni G, Ghiara F, Barachini P, Mariani G: Molecular staging of the sentinel lymph node in melanoma patients: correlation with clinical outcome. Ann Oncol; 2005 Nov;16(11):1832-40
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  • [Title] Molecular staging of the sentinel lymph node in melanoma patients: correlation with clinical outcome.
  • BACKGROUND: This study was designed to determine the debated prognostic significance of reverse transcriptase-polymerase chain reaction (RT-PCR) positivity in melanoma patients' sentinel lymph node (SLN) negative by conventional histopathology (PATH).
  • PATIENTS AND METHODS: Patients with primary stage I-II cutaneous melanoma underwent radioguided sentinel lymphadenectomy.
  • Their SLNs were assessed for tyrosinase (Tyr) and melanoma antigens recognized by T-cells (MART-1) mRNA expression using RT-PCR, in parallel with hematoxylin and eosin staining and immunohistochemistry.
  • Tyr and MART-1 expression in the SLNs were correlated with PATH assay results, standard prognostic factors, time to progression and overall survival.
  • CONCLUSIONS: RT-PCR is more sensitive than PATH to detect SLN metastases and it is a reliable predictor of disease relapse in stage I-II melanoma patients.

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  • (PMID = 16107497.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antigens, Neoplasm; 0 / MART-1 Antigen; 0 / MLANA protein, human; 0 / Neoplasm Proteins; 0 / RNA, Messenger; EC 1.14.18.1 / Monophenol Monooxygenase
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27. Bütter A, Hui T, Chapdelaine J, Beaunoyer M, Flageole H, Bouchard S: Melanoma in children and the use of sentinel lymph node biopsy. J Pediatr Surg; 2005 May;40(5):797-800
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  • [Title] Melanoma in children and the use of sentinel lymph node biopsy.
  • BACKGROUND: The rarity of pediatric melanoma prompted our review of sentinel lymph node biopsy (SLNB) and associated prognosis.
  • METHODS: A chart review from 1989 to 2004 revealed 12 cases of cutaneous melanoma.
  • Variables analyzed included demographics, site, histology, tumor characteristics, nodal status, and distant metastasis (TMN status), SLNB and/or therapeutic lymph node dissection (TLND), adjuvant treatment, disease-free survival, and overall survival.
  • All patients had wide local excision and primary closure or skin graft.
  • Disease-free survival and overall survival by stage were stage I (n = 2, 3.9 years, 100%), stage II (n = 6, 7.7 years, 83%), stage III (n = 4, 2.6 years, 75%), and stage IV (n = 0).
  • A stage II patient with negative SLNB, adjuvant chemotherapy, and interferon died 26 months after diagnosis, and a stage III patient with clinically and pathologically positive nodes after TLND died 15 months after diagnosis.
  • CONCLUSION: Although a negative SLNB does not guarantee a favorable prognosis, its increasing use will further define its role in pediatric melanoma.
  • [MeSH-major] Lymphatic Metastasis / diagnosis. Melanoma / secondary. Sentinel Lymph Node Biopsy. Skin Neoplasms / surgery
  • [MeSH-minor] Adolescent. Antineoplastic Agents / therapeutic use. Chemotherapy, Adjuvant. Child. Child, Preschool. Combined Modality Therapy. Disease-Free Survival. Female. Head and Neck Neoplasms / pathology. Head and Neck Neoplasms / surgery. Humans. Infant. Interferons / therapeutic use. Lymph Node Excision. Male. Prognosis. Retrospective Studies. Survival Analysis

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  • (PMID = 15937817.001).
  • [ISSN] 1531-5037
  • [Journal-full-title] Journal of pediatric surgery
  • [ISO-abbreviation] J. Pediatr. Surg.
  • [Language] eng
  • [Publication-type] Evaluation Studies; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 9008-11-1 / Interferons
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28. 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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  • [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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29. 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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30. Weber JS, Samlowski WE, Gonzalez R, Ribas A, Stephenson J, O'Day S, Sato T, Dorr R, Grenier K, Hersh E: A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma. Cancer; 2010 Aug 1;116(15):3683-91
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  • [Title] A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma.
  • Preclinical studies showed activity against melanoma cell lines and models in mice, and synergy with dacarbazine.
  • METHODS: Sixty-eight chemotherapy-naive melanoma patients (1 inoperable stage III and 67 stage IV) were treated with dacarbazine (250 mg/m2) and imexon (570-1300 mg/m2), both daily for 5 days every 3 weeks.
  • At the MTD, therapy was well tolerated.
  • Among 68 patients, there were 7 treatment-related serious adverse events.
  • Pharmacokinetics of both drugs were similar to previous reports.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Dacarbazine / administration & dosage. Hexanones / administration & dosage. Melanoma / drug therapy
  • [MeSH-minor] Aged. Aged, 80 and over. Female. Humans. Male. Maximum Tolerated Dose. Middle Aged. Neoplasm Metastasis. Skin Neoplasms / drug therapy. Skin Neoplasms / pathology

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  • [Copyright] Copyright (c) 2010 American Cancer Society.
  • (PMID = 20564083.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Hexanones; 59643-91-3 / 4-imino-1,3-diazabicyclo(3.1.0)hexan-2-one; 7GR28W0FJI / Dacarbazine
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31. Kim KB, Bedikian AY, Camacho LH, Papadopoulos NE, McCullough C: A phase II trial of arsenic trioxide in patients with metastatic melanoma. Cancer; 2005 Oct 15;104(8):1687-92
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  • [Title] A phase II trial of arsenic trioxide in patients with metastatic melanoma.
  • BACKGROUND: Arsenic trioxide induces growth inhibition and apoptosis in human melanoma cell lines.
  • Therefore, a Phase II trial was conducted to evaluate the efficacy and toxicity of single-agent arsenic trioxide in patients with Stage IV melanoma.
  • METHODS: Twenty patients, 10 with metastatic melanoma of cutaneous origin and 10 with metastatic melanoma of choroidal origin, received arsenic trioxide 0.25 mg/kg/day for 5 days, followed by a maintenance dose of 0.35 mg/kg/day twice a week.
  • All patients with melanoma of cutaneous origin and four patients with melanoma of choroidal origin had received prior therapy.
  • Eight patients (five with melanoma of cutaneous origin, and three with melanoma of choroidal origin) had disease stabilization for at least six weeks.
  • The median overall survival duration for patients with melanoma of cutaneous origin was 7.9 months, and that of patients with melanoma of choroidal origin has not been reached at a median follow-up duration of 11.8 months.
  • Future clinical trials should evaluate arsenic trioxide in combination with other anticancer drugs that may improve its clinical activity in melanoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Arsenicals / therapeutic use. Choroid Neoplasms / drug therapy. Melanoma / drug therapy. Oxides / therapeutic use. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Female. Humans. Lymphatic Metastasis / pathology. Male. Middle Aged. Survival Rate. Treatment Outcome

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  • [Copyright] Copyright 2005 American Cancer Society
  • (PMID = 16130126.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Arsenicals; 0 / Oxides; S7V92P67HO / arsenic trioxide
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32. Radny P, Caroli UM, Bauer J, Paul T, Schlegel C, Eigentler TK, Weide B, Schwarz M, Garbe C: Phase II trial of intralesional therapy with interleukin-2 in soft-tissue melanoma metastases. Br J Cancer; 2003 Nov 3;89(9):1620-6
The Lens. Cited by Patents in .

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  • [Title] Phase II trial of intralesional therapy with interleukin-2 in soft-tissue melanoma metastases.
  • The objective of the present study was to validate the use of intralesional injection of interleukin-2 (IL-2) in patients with skin and soft-tissue melanoma metastases.
  • A total of 24 patients with AJCC stage III or IV melanoma and single or multiple skin and soft-tissue metastases were included.
  • Interleukin-2 injections were administered intralesionally into the total number of cutaneous and soft-tissue metastases accessible from the skin, 2-3 times weekly, over 1-57 weeks.
  • The therapy was generally well tolerated; the observed adverse events were mainly of grade 1-2 severity.
  • The unusual high CR rate in metastatic melanoma of 62.5% and the limited toxicity suggest that treatment of skin and soft-tissue melanoma metastases with intralesional injection of IL-2 may be a safe and effective alternative to conventional therapies.
  • The optimal dosage and duration of this therapy still remain to be defined in larger prospective multicentre trials.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Interleukin-2 / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy. Soft Tissue Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Apoptosis. Female. Humans. Immunohistochemistry. Injections, Intralesional. Male. Microscopy, Confocal. Middle Aged. Treatment Outcome

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  • (PMID = 14583759.001).
  • [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] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Interleukin-2
  • [Other-IDs] NLM/ PMC2394422
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33. Bedikian AY, Richards J, Kharkevitch D, Atkins MB, Whitman E, Gonzalez R: A phase 2 study of high-dose Allovectin-7 in patients with advanced metastatic melanoma. Melanoma Res; 2010 Jun;20(3):218-26
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  • [Title] A phase 2 study of high-dose Allovectin-7 in patients with advanced metastatic melanoma.
  • A phase 2 dose-escalation study (VCL-1005-208) was conducted to evaluate the safety and efficacy of Allovectin-7 in patients with metastatic melanoma.
  • Eligible patients had stage III or IV metastatic melanoma recurrent or unresponsive to prior therapy, an Eastern Cooperative Oncology Group performance status 0 or 1, and adequate organ function.
  • A histological examination of tissue from two responding patients who had their lesions resected has shown no evidence of melanoma.
  • Median time-to-progression in this study was 1.6 months.
  • In conclusion, these results indicate that high-dose Allovectin-7 seems to be an active, well-tolerated treatment for selected stage III/IV metastatic melanoma patients with injectable cutaneous, subcutaneous, or nodal lesions.
  • [MeSH-major] DNA, Recombinant / therapeutic use. Lipids / therapeutic use. Melanoma / drug therapy. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Dose-Response Relationship, Drug. Female. Humans. Immunotherapy / methods. Male. Middle Aged. Models, Statistical. Neoplasm Metastasis. Treatment Outcome

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  • (PMID = 20354459.001).
  • [ISSN] 1473-5636
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Allovectin-7; 0 / DNA, Recombinant; 0 / Lipids
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34. 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 .

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  • [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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35. Moschos SJ, Odoux C, Land SR, Agarwala S, Friedland D, Volker KM, Sidor C, Wong M, Kirkwood JM: Endostatin plus interferon-alpha2b therapy for metastatic melanoma: a novel combination of antiangiogenic and immunomodulatory agents. Melanoma Res; 2007 Jun;17(3):193-200
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  • [Title] Endostatin plus interferon-alpha2b therapy for metastatic melanoma: a novel combination of antiangiogenic and immunomodulatory agents.
  • In patients with stage IIB-III disease, adjuvant high-dose interferon-alpha2b has shown clinical benefit, although metastatic melanoma is currently without any known survival-prolonging therapy.
  • Angiogenesis has been considered important in melanoma progression, and endostatin is an angiogenesis inhibitor with antitumor activity that has shown promising results in murine model systems, prompting investigation of a formulation of rh-Endostatin (EntreMed, Rockville, Maryland, USA) alone and with interferon in metastatic melanoma.
  • Patients were randomly assigned to receive interferon alpha2b (Schering-Plough) 10 million units/m(2) subcutaneously three times a week plus rh-Endostatin 45 mg/m(2) subcutaneously every 12 h (arm A) vs. rh-Endostatin alone (arm B).
  • Twenty-one patients (age range 31-77 years, median age 54, 12 men and nine women, 17 cutaneous, and four ocular melanomas) were enrolled.
  • No antitumor responses were observed, and no significant differences were noted in time to progression or overall survival.
  • Two patients had stable disease enduring more than 30 weeks on treatment.
  • Serum endostatin levels increased significantly 4 weeks after treatment in both groups.
  • Basic fibroblast growth factor levels in urine were significantly lower following treatment in patients on arm B (P=0.043).
  • The percentage of circulating endothelial cells was increased in five evaluable patients 4 weeks after treatment.

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  • (PMID = 17505265.001).
  • [ISSN] 0960-8931
  • [Journal-full-title] Melanoma research
  • [ISO-abbreviation] Melanoma Res.
  • [Language] ENG
  • [Grant] United States / NCATS NIH HHS / TR / UL1 TR000005; United States / NCI NIH HHS / CA / P30 CA4790413
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Angiogenesis Inhibitors; 0 / Endostatins; 0 / Immunologic Factors; 0 / Interferon-alpha; 0 / Recombinant Proteins; 99210-65-8 / interferon alfa-2b
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36. Bleomycin--electrical pulse delivery: electroporation therapy-bleomycin--Genetronics; MedPulser-bleomycin--Genetronics. Drugs R D; 2004;5(5):293-6
Hazardous Substances Data Bank. BLEOMYCIN .

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  • [Title] Bleomycin--electrical pulse delivery: electroporation therapy-bleomycin--Genetronics; MedPulser-bleomycin--Genetronics.
  • Genetronics Biomedical is using its electroporation therapy technology to deliver bleomycin to tumour cells for the treatment of cancer.
  • Genetronics have developed the MedPulser Electroporation Therapy System, which consists of an electrical pulse generator and disposable electrode applicators.
  • After the field is discontinued, the pores close, trapping the therapeutic molecules inside the target cells.
  • Genetronics is seeking a licensing partner for the use of electroporation for the delivery of drugs in chemotherapy.
  • In 1997, Genetronics entered an agreement with Abbott Laboratories for the manufacture of bleomycin for use in the US in its MedPulsar system after regulatory approval had been granted for its use in the treatment of solid tumours.
  • The MedPulsar Electroporation Therapy System with bleomycin is currently in phase III pivotal studies in the US as a treatment for recurrent and second primary squamous cell carcinomas of the head and neck.
  • Genetronics received approval for the Electroporation Therapy system as a device in March 1999 when it achieved CE Mark certification.
  • In February 2004, Genetronics announced that it had completed a Special Protocol Assessment review process with the US FDA for two new trials that will compare bleomycin electroporation therapy to surgery.
  • The primary endpoint will be tissue and function preservation rather than survival.
  • One proposal is for recurrent head and neck cancer, and the other is for disfiguring cutaneous cancer.
  • In June 2004, Genetronics was granted fast-track status for its MedPulsar Electroporation Therapy System clinical development programme for patients with head and neck cancer.
  • This includes a phase III trial for late-stage, recurrent head and neck cancer in combination with the normal standard of treatment compared with normal standard of treatment alone.
  • Interim results from this trial had suggested bleomycin electroporation therapy demonstrated local tumour control and preservation of organ function, as well as non-inferiority when compared with surgery.
  • Prior clinical trials established the safety and performance of the MedPulser System for the treatment of SCCHN, leading to approval for sale in the EU based on achieving the CE Mark.
  • The bleomycin delivery system has completed phase IIB trials in the US, Canada and Europe in patients with squamous cell carcinoma of the head and neck who have failed conventional therapies.
  • Phase II data were submitted to the FDA in the first quarter of 2002 and a phase III trial was launched in May 2002.
  • The therapy is also being used in France in patients with cancers of the head and neck, liver (metastatic) and melanoma.
  • A review of the data from these phase II trials was completed in April 2001.
  • US patent 6,748,265 covers its trans-surface drug and gene delivery technology and provides additional proprietary rights for an apparatus and method to deliver genes, drugs and other molecules through tissue surfaces.
  • The second US patent, 6,746,441, pertains to the field of ex vivo therapies and covers the introduction of molecules into cells by electroporation, either in a continuous-flow or batch mode, with a variable electric field orientation.
  • In July 2004, Genetronics received a US patent (no. 6,763,264) covering methods for the in vivo delivery of a recombinant expression vector (DNA) or a pharmaceutical agent into tissue cells, and a method for the therapeutic application of electroporation to a patient to introduce macromolecules.
  • [MeSH-major] Antibiotics, Antineoplastic / administration & dosage. Antibiotics, Antineoplastic / therapeutic use. Bleomycin / administration & dosage. Bleomycin / therapeutic use. Electroporation / instrumentation
  • [MeSH-minor] Carcinoma, Squamous Cell / drug therapy. Clinical Trials, Phase II as Topic. Clinical Trials, Phase III as Topic. Head and Neck Neoplasms / drug therapy. Humans. Patents as Topic

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  • [Copyright] Copyright 2004 Adis Data Information BV
  • (PMID = 15357628.001).
  • [ISSN] 1174-5886
  • [Journal-full-title] Drugs in R&D
  • [ISO-abbreviation] Drugs R D
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; 11056-06-7 / Bleomycin
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37. Sciubba JJ: Oral cancer. The importance of early diagnosis and treatment. Am J Clin Dermatol; 2001;2(4):239-51
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] Oral cancer. The importance of early diagnosis and treatment.
  • Mortality due to cancers in this region exceeds the annual death rate is the US caused by either cutaneous melanoma or cervical cancer.
  • These alterations affect epithelial cell behavior by way of loss of chromosomal heterozygosity which in turn leads to a series of events progressing to the ultimate stage of invasive squamous cell carcinoma.
  • Proliferative verrucous leukoplakia represents a relatively new type of leukoplakia that is separate from the more common or less innocuous form of this condition.
  • Squamous cell carcinoma will develop from antecedent dysplastic oral mucosal lesions if an early diagnosis has not been made and treatment given.
  • Early diagnosis within stages I and II correspond to a vastly improved 5-year survival rate when compared with more advanced stage III and IV lesions.
  • Surgical management of this disease remains the mainstay of treatment.
  • Other therapies include radiation and chemotherapy options that may be used adjunctively and palliatively.
  • Following treatment, it is important to understand the significant risks of second primary cancers developing within the upper aerodigestive tract as a result of field cancerization.
  • The most important message is that early detection of the asymptomatic early stage oral cancer translates in general terms to satisfactory clinical outcome and cure in most patients.
  • [MeSH-minor] Biopsy. Carcinoma, Squamous Cell / diagnosis. Carcinoma, Squamous Cell / pathology. Carcinoma, Squamous Cell / surgery. Carcinoma, Squamous Cell / therapy. Carcinoma, Verrucous / diagnosis. Carcinoma, Verrucous / pathology. Carcinoma, Verrucous / surgery. Carcinoma, Verrucous / therapy. Combined Modality Therapy. Diagnosis, Differential. Humans. Leukoplakia, Oral / diagnosis. Leukoplakia, Oral / pathology. Leukoplakia, Oral / surgery. Leukoplakia, Oral / therapy. Neoplasm Staging. Palatal Neoplasms / diagnosis. Palatal Neoplasms / pathology. Palatal Neoplasms / surgery. Palatal Neoplasms / therapy. Palliative Care. Prognosis. Risk Factors. Time Factors. Tongue / pathology. Tongue Neoplasms / diagnosis. Tongue Neoplasms / pathology. Tongue Neoplasms / surgery. Tongue Neoplasms / therapy. World Health Organization

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  • (PMID = 11705251.001).
  • [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
  • [Number-of-references] 39
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38. 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
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  • [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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39. Schad K, Baumann Conzett K, Zipser MC, Enderlin V, Kamarashev J, French LE, Dummer R: Mitogen-activated protein/extracellular signal-regulated kinase kinase inhibition results in biphasic alteration of epidermal homeostasis with keratinocytic apoptosis and pigmentation disorders. Clin Cancer Res; 2010 Feb 1;16(3):1058-64
NCI CPTC Antibody Characterization Program. NCI CPTC Antibody Characterization Program .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • PURPOSE: Raf/mitogen-activated protein/extracellular signal-regulated kinase (ERK) kinase (MEK)/ERK signaling pathway is constitutively activated in melanoma.
  • We focus on associated cutaneous toxicity and we attempt to understand the underlying pathophysiology and design treatment strategies.
  • EXPERIMENTAL DESIGN: Dermatologic conditions of 22 patients with unresectable melanoma stage III/IV in a phase II trial were evaluated.
  • Biopsies were compared with matched controls in normal skin.
  • Half-side treatment of acute skin toxicity compared therapeutic options.
  • RESULTS: Nineteen of 22 (86%) AZD6244-treated patients presented with cutaneous eruptions.
  • Seventeen patients (77%) developed acute papulopustular rash.
  • Chronic skin changes included xerosis, paronychia, and fissured fingertips, resembling cutaneous toxicity of epidermal growth factor receptor inhibition.
  • In addition, we observed reduced pigmentation of hair and skin.
  • Histology of acute skin lesions revealed a significant increase of apoptotic keratinocytes (P = 0.0008), focal neutrophilic infiltrates, destruction of the adnexal structures by neutrophils, and reduced cytokeratins.
  • Corticosteroids plus antibacterial topical therapy ameliorate acute skin toxicity.
  • CONCLUSIONS: AZD6244-associated skin reactions partly overlap with those observed upon epidermal growth factor receptor inhibition.
  • Additionally, pigmentation of skin and hair is affected.
  • The interruption of the MEK signaling pathway results in an acute keratinocyte stress response with disturbed epidermal homeostasis, inflammation, and tissue damage.
  • Chronic adaptation controls inflammatory tissue damage but leads to cutaneous malfunctions that explain chronic skin toxicity.
  • [MeSH-major] Benzimidazoles / adverse effects. Extracellular Signal-Regulated MAP Kinases / antagonists & inhibitors. Melanoma / drug therapy. Pigmentation Disorders / chemically induced. Skin Neoplasms / drug therapy
  • [MeSH-minor] Adult. Apoptosis. Drug Eruptions / etiology. Exanthema / chemically induced. Female. Homeostasis. Humans. Keratinocytes / pathology. Male. Middle Aged. Mitogen-Activated Protein Kinases / antagonists & inhibitors. Protein Kinase Inhibitors






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