HIGH-DOSE IFN-ALPHA-2B VS CISPLATIN, VINBLASTINE, DTIC + IL-2 & IFN IN MELANOMA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. (Clinical trial summary from the National Cancer Institute's PDQ database) Interferon alfa may interfere with the growth of cancer cells. 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. It is not yet known whether interferon alfa is more effective at preventing recurrences for patients with surgically removed melanoma at high risk for recurrence if given alone for one year or if given with combination chemotherapy and interleukin-2 over a 9 week period of time. This is a randomized Phase III trial to compare the effectiveness of interferon alfa given alone for one year with a 9 week treatment including chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2 and interferon alfa, for patients with surgically removed melanoma at high risk for recurrence. Patients will be randomly assigned to one of two groups. Patients in group one will receive infusions of interferon alfa 5 days a week for 4 weeks and then injections of interferon alfa 3 days a week for 48 weeks. Patients in group two will receive infusions of cisplatin and vinblastine on Days 1-4, an infusion of dacarbazine on Day 1, and a 4-day continuous infusion of interleukin-2 beginning on Day 1. They will also receive injections of interferon alfa on Days 1-5, 8, 10, and 12, and injections of filgrastim on Days 6-15. Treatment may be repeated every 3 weeks for three courses. Patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and then once a year for 5 years.