Combination Chemotherapy With or Without Interleukin-2 and Interferon Alfa 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. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma.
PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.
Biological: recombinant interferon alfa
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma|
- Overall survival [ Designated as safety issue: No ]
- Response rate (complete and partial response) [ Designated as safety issue: No ]
- Durable complete response rate [ Designated as safety issue: No ]
- Response duration [ Designated as safety issue: No ]
|Study Start Date:||October 1997|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- Compare response rate, duration of response, and survival rate in patients with metastatic malignant melanoma treated with cisplatin, vinblastine, and dacarbazine with or without interleukin-2 and interferon alfa-2b.
- Determine the toxic effects of these regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive cisplatin IV over 30 minutes daily immediately followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 60 minutes on day 1 following vinblastine.
- Arm II: Patients receive treatment as in arm I. Patients also receive interleukin 2 (IL-2) IV continuously on days 1-4 and interferon alfa-2b subcutaneously (SC) daily before IL-2 on days 1-4 and after IL-2 on day 5, followed by filgrastim (G-CSF) (SC) daily on days 7-16.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 6 weeks, every 3 months for 18 months, every 6 months for 18 months, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 482 patients will be accrued for this study within 3.5 years.
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|Study Chair:||Michael B. Atkins, MD||Tufts Medical Center|
|Study Chair:||Lawrence E. Flaherty, MD||Barbara Ann Karmanos Cancer Institute|
|Study Chair:||David M. Gustin, MD||University of Illinois at Chicago|