Melanoma (Skin) Clinical Trial
Official title:
TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL
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.
OBJECTIVES:
- 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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