Melanoma (Skin) Clinical Trial
Official title:
Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Biological therapies use different ways to stimulate the immune
system and stop cancer cell from growing. Combining more than one drug with different types
of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
biological therapy in treating patients who have metastatic melanoma.
OBJECTIVES:
- Determine the toxicity of cisplatin and dacarbazine followed by sargramostim (GM-CSF),
interferon alfa, and interleukin-2 in patients with metastatic melanoma.
- Determine the objective response rate, relapse free survival, and overall survival of
these patients on this regimen.
OUTLINE: Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes
sequentially on day 1, followed by sargramostim (GM-CSF) subcutaneously (SC) on days 2-7,
interleukin-2 SC on days 8-14, and interferon alfa SC on days 8, 10, 12, and 14. Treatment
repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression, and then every 8-12 weeks
thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within 3 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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