Melanoma (Skin) Clinical Trial
Official title:
A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma
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 cancer cells.
Combining chemotherapy with interferon alfa may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon
alfa in treating patients who have stage III or stage IV melanoma.
OBJECTIVES:
- Determine the response rate in patients with advanced melanoma treated with
temozolomide and pegylated interferon alfa.
- Determine the toxicity profile of this regimen in these patients.
- Determine the duration of disease response and overall survival of patients treated
with this regimen.
OUTLINE: Patients are stratified according to CNS metastases (yes vs no).
Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa
subcutaneously once weekly on weeks 1-8. Courses repeat every 8 weeks in the absence of
disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 23-61 patients (12-35 without CNS metastases and 11-26 with
CNS metastases) will be accrued for this study within 18 months.
;
Primary Purpose: Treatment
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