Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00026520|
Recruitment Status : Completed
First Posted : June 25, 2003
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: recombinant interferon alfa Drug: thalidomide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II|
|Study Start Date :||November 2001|
|Actual Study Completion Date :||April 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026520
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|Study Chair:||Laura F. Hutchins, MD||University of Arkansas|