Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV 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.
Biological: pegylated interferon alfa
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma|
|Study Start Date:||May 2001|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
- 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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Wen-Jen Hwu, MD, PhD||Memorial Sloan-Kettering Cancer Center|