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Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States
Start Date
November 1, 2001
Completion Date
April 1, 2006
Last Updated
June 24, 2013
recombinant interferon alfa
BIOLOGICAL
thalidomide
DRUG
Lead Sponsor
SWOG Cancer Research Network
Collaborators
NCT04079166
NCT04911998
Data Source & Attribution
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