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Thalidomide in Treating Patients With HIV-Associated Kaposi's Sarcoma

Phase 2
Completed
Conditions
Sarcoma
Registration Number
NCT00019123
Lead Sponsor
National Cancer Institute (NCI)
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Medicine Branch

πŸ‡ΊπŸ‡Έ

Bethesda, Maryland, United States

Medicine Branch
πŸ‡ΊπŸ‡ΈBethesda, Maryland, United States

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