Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma
- 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
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
Objective response rate
Thomas F. Gajewski, MD, PhD
University of Chicago
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|