A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
- Conditions
- Sarcoma, KaposiHIV Infections
- Registration Number
- NCT00002318
- Lead Sponsor
- Sequus Pharmaceuticals
- Brief Summary
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.
- Detailed Description
Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 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 must agree to have one or more representative KS lesions biopsied.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 225
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 (26)
Dr Mahmoud Mustafa
🇺🇸Washington, District of Columbia, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Apogee Med Group
🇺🇸San Diego, California, United States
UCSF
🇺🇸San Francisco, California, United States
Rush Presbyterian Med College
🇺🇸Chicago, Illinois, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Comprehensive Care Ctr
🇺🇸Dallas, Texas, United States
Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
American Med Research Institute
🇺🇸Atlanta, Georgia, United States
Washington Univ
🇺🇸St Louis, Missouri, United States
Dr Becky Miller
🇺🇸Los Angeles, California, United States
Pacific Oaks Med Group
🇺🇸Sherman Oaks, California, United States
New York Univ Med Ctr
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources
🇺🇸Atlanta, Georgia, United States
Northwestern Med Faculty Foundation
🇺🇸Chicago, Illinois, United States
Graduate Hosp / Tuttleman Cancer Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Hematology - Oncology Med Group of San Fernando Valley
🇺🇸Encino, California, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
San Francisco Veterans Administration Med Ctr
🇺🇸San Francisco, California, United States
Illinois Masonic Med Ctr / The Cancer Ctr
🇺🇸Chicago, Illinois, United States
H Lee Moffit Cancer Ctr and Research Institute
🇺🇸Tampa, Florida, United States
Saint Vincent's Hosp and Med Ctr
🇺🇸New York, New York, United States