Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
- Determine the response rate in patients with recurrent or metastatic malignant melanoma
treated with PEG-interferon alfa-2b and thalidomide.
- Determine the quantitative and qualitative toxic effects of this regimen in these
- Determine progression-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral
thalidomide once daily. Treatment continues for at least 2 weeks but no more than 8 months
in the absence of disease progression or unacceptable toxicity. Patients achieving a
complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond
documentation of CR.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38
Masking: Open Label, Primary Purpose: Treatment
Response rate as measured scans and tumor measurements every 8 weeks
Ulka N. Vaishampayan, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|