Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
- Conditions
- Sarcoma, KaposiHIV Infections
- Registration Number
- NCT00002105
- Lead Sponsor
- Sequus Pharmaceuticals
- Brief Summary
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.
- Detailed Description
Patients are randomized to receive either DOX-SL or the BV combination. Infusions are given on day 1 and every 3 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients who respond to therapy will be followed every 2 months for up to 1 year. Patients must agree to have one or more representative KS lesions biopsied.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Beth Israel Hosp
🇺🇸Boston, Massachusetts, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Twelve Oaks Hosp
🇺🇸Houston, Texas, United States
Virginia Mason Research Center / Clinical Trial Unit
🇺🇸Seattle, Washington, United States
Beth Israel Hosp🇺🇸Boston, Massachusetts, United States