Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
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.
Biological: recombinant interferon alfa
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL|
|Study Start Date:||June 1995|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
- Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.
- Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002669
|Landeskrankenanstalten - Salzburg|
|Salzburg, Austria, A-5020|
|Hopital Universitaire Erasme|
|Brussels, Belgium, 1070|
|Institut Jules Bordet|
|Brussels (Bruxelles), Belgium, 1000|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|CHR de Besancon - Hopital Saint-Jacques|
|Besancon, France, 25030|
|Centre Leon Berard|
|Lyon, France, 69373|
|Paris, France, 75651|
|Universitaetsklinikum Benjamin Franklin|
|Berlin, Germany, D-12200|
|Berlin, Germany, D-10117|
|Robert Roessle Klinik|
|Berlin, Germany, D-13122|
|Haematologisch-Onkologische Praxis Altona|
|Hamburg, Germany, D-22765|
|Johannes Gutenberg University|
|Mainz, Germany, D-55101|
|III Medizinische Klinik Mannheim|
|Mannheim, Germany, D-68135|
|Istituto Europeo Di Oncologia|
|Milano, Italy, 20141|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Rotterdam Cancer Institute|
|Rotterdam, Netherlands, 3075 EA|
|Instituto Portugues de Oncologia do Porto|
|Porto, Portugal, 4200|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Zurich, Switzerland, CH-8091|
|St. James's Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Royal Marsden NHS Trust|
|London, England, United Kingdom, SW3 6JJ|
|Southend NHS Trust Hospital|
|Westcliff-On-Sea, England, United Kingdom|
|Royal Bournemouth Hospital|
|Bournemouth, United Kingdom, BH7 7DW|
|Study Chair:||Ulrich Keilholz, MD||Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin|