NCT00027742

Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Intraocular Melanoma
• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	pegylated interferon alfa
DRUG	temozolomide

Timeline

• Start date: 2001-05-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2003-01-27
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States