TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Ulrich Keilholz, MD
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
United States: Federal Government