Thalidomide in Treating Patients With HIV-Associated Kaposi's Sarcoma
RATIONALE: Thalidomide may kill cancer cells by stopping the growth of new blood vessels to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients with HIV-associated Kaposi's sarcoma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A PHASE II STUDY OF ORAL THALIDOMIDE FOR PATIENTS WITH HIV INFECTION AND KAPOSI'S SARCOMA|
|Study Start Date:||April 1996|
|Study Completion Date:||April 2004|
OBJECTIVES: I. Determine the antitumor activity of thalidomide in terms of regression or stabilization of disease in patients with HIV-associated Kaposi's sarcoma. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: Patients receive oral thalidomide on day 1. Treatment continues daily for 6 months in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after 6 months of treatment may continue treatment for an additional 6 months. Patients are followed at 1, 6, and 12 months.
PROJECTED ACCRUAL: A total of 15-25 evaluable patients will be accrued for this study within 3.75-6.25 months.
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Robert Yarchoan, MD||National Cancer Institute (NCI)|