NCT00026520

Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma

Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of the tumor. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining interferon alfa with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with thalidomide in treating patients who have stage IV melanoma.

Detailed description

OBJECTIVES: * Determine the 6-month progression-free survival rate in patients with stage IV melanoma treated with interferon alfa and thalidomide. * Determine the confirmed and unconfirmed complete and partial response rates in patients with measurable disease treated with this regimen. * Determine the quantitative and qualitative toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses after documentation of CR. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interferon alfa
DRUG	thalidomide

Timeline

• Start date: 2001-11-01
• Completion: 2006-04-01
• First posted: 2003-06-25
• Last updated: 2013-06-24

Locations

94 sites across 1 country: United States