Thalidomide in Treating Patients With HIV-Associated Kaposi's Sarcoma
|ClinicalTrials.gov Identifier: NCT00019123|
Recruitment Status : Completed
First Posted : April 13, 2004
Last Update Posted : August 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: thalidomide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A PHASE II STUDY OF ORAL THALIDOMIDE FOR PATIENTS WITH HIV INFECTION AND KAPOSI'S SARCOMA|
|Study Start Date :||April 1996|
|Actual Study Completion Date :||April 2004|
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): NCT00019123
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Robert Yarchoan, MD||National Cancer Institute (NCI)|