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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00238329
Study type Interventional
Source Barbara Ann Karmanos Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date January 2001
Completion date June 2007

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