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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002669 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: aldesleukin Drug: cisplatin Drug: dacarbazine Drug: recombinant interferon alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL |
Estimated Enrollment: | 90 |
Study Start Date: | June 1995 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.
Patients are followed every 2 months for 6 months, then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable, progressive disease (by physical exam and/or noninvasive imaging)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Austria | |
Landeskrankenanstalten - Salzburg | |
Salzburg, Austria, A-5020 | |
Belgium | |
Hopital Universitaire Erasme | |
Brussels, Belgium, 1070 | |
Institut Jules Bordet | |
Brussels (Bruxelles), Belgium, 1000 | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
France | |
Centre Leon Berard | |
Lyon, France, 69373 | |
CHR de Besancon - Hopital Saint-Jacques | |
Besancon, France, 25030 | |
CHU Pitie-Salpetriere | |
Paris, France, 75651 | |
Germany | |
Haematologisch-Onkologische Praxis Altona | |
Hamburg, Germany, D-22765 | |
III Medizinische Klinik Mannheim | |
Mannheim, Germany, D-68135 | |
Johannes Gutenberg University | |
Mainz, Germany, D-55101 | |
Robert Roessle Klinik | |
Berlin, Germany, D-13122 | |
Universitaetsklinikum Benjamin Franklin | |
Berlin, Germany, D-12200 | |
Universitaetsklinikum Charite | |
Berlin, Germany, D-10117 | |
Italy | |
Istituto Europeo Di Oncologia | |
Milano, Italy, 20141 | |
Netherlands | |
Rotterdam Cancer Institute | |
Rotterdam, Netherlands, 3075 EA | |
University Medical Center Nijmegen | |
Nijmegen, Netherlands, NL-6500 HB | |
Portugal | |
Instituto Portugues de Oncologia do Porto | |
Porto, Portugal, 4200 | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, CH-1011 | |
Universitaetsspital | |
Zurich, Switzerland, CH-8091 | |
United Kingdom | |
Royal Bournemouth Hospital | |
Bournemouth, United Kingdom, BH7 7DW | |
United Kingdom, England | |
Royal Marsden NHS Trust | |
London, England, United Kingdom, SW3 6JJ | |
Southend NHS Trust Hospital | |
Westcliff-On-Sea, England, United Kingdom | |
St. James's Hospital | |
Leeds, England, United Kingdom, LS9 7TF |
Study Chair: | Ulrich Keilholz, MD | Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin |
Study ID Numbers: | CDR0000064258, EORTC-18951 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002669 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Interferon-alpha Interferon Type I, Recombinant Dacarbazine Interferons Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Aldesleukin Cisplatin Interleukin-2 Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Interferon Alfa-2a |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Anti-Retroviral Agents Therapeutic Uses Nevi and Melanomas Antineoplastic Agents, Alkylating Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents |