Melanoma (Skin) Clinical Trial
Official title:
Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological
therapies, such as thalidomide, may stimulate the immune system in different ways and stop
tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of
melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with
thalidomide may be an effective treatment for melanoma.
PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together
with thalidomide works in treating patients with recurrent or metastatic melanoma.
OBJECTIVES:
- 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
patients.
- 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
months.
;
Masking: Open Label, Primary Purpose: Treatment
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