Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection
- Conditions
- Sarcoma
- Registration Number
- NCT00019240
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Herpesvirus is found in Kaposi's sarcoma lesions in most patients; it is therefore possible that the herpesvirus has a role in causing Kaposi's sarcoma. Cidofovir is an antiviral drug that acts against many types of herpesvirus, and may be an effective treatment for Kaposi's sarcoma.
PURPOSE: Phase II trial to study the effectiveness of cidofovir in treating patients with Kaposi's sarcoma with or without HIV infection.
- Detailed Description
OBJECTIVES: I. Assess the antitumor activity of intravenous cidofovir in patients with Kaposi's sarcoma (KS) with and without human immunodeficiency virus (HIV) infection. II. Assess the effect of intravenous cidofovir on the load of KS-associated herpesvirus/human herpesvirus-8 in KS lesions and peripheral blood mononuclear cells by quantitative polymerase chain reaction. III. Assess the toxicity of cidofovir in KS patients with and without HIV infection. IV. Assess the effect of cidofovir on angiogenic cytokines related to the pathogenesis of KS.
OUTLINE: All patients receive intravenous cidofovir weekly for 2 weeks, then every other week for 6 months. Patients with a complete or partial response may continue treatment until disease progression intervenes.
PROJECTED ACCRUAL: Up to 25 evaluable patients will be entered over approximately 6 months if there are at least 2 responses in the first 15 patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medicine Branch
🇺🇸Bethesda, Maryland, United States