A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
- Conditions
- Sarcoma, KaposiHIV Infections
- Registration Number
- NCT00002319
- Lead Sponsor
- Sequus Pharmaceuticals
- Brief Summary
To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.
- Detailed Description
Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.
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 (31)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
H Lee Moffit Cancer Ctr and Research Institute
🇺🇸Tampa, Florida, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Houston Immunological Institute
🇺🇸Houston, Texas, United States
American Med Research Institute
🇺🇸Atlanta, Georgia, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
San Francisco Veterans Administration Med Ctr
🇺🇸San Francisco, California, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Dr Mahmoud Mustafa
🇺🇸Washington, District of Columbia, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Washington Univ
🇺🇸St. Louis, Missouri, United States
Saint Vincent's Hosp and Med Ctr
🇺🇸New York, New York, United States
Graduate Hosp / Tuttleman Cancer Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Twelve Oaks Hosp
🇺🇸Houston, Texas, United States
Pacific Oaks Med Group
🇺🇸Sherman Oaks, California, United States
Hematology - Oncology Med Group of San Fernando Valley
🇺🇸Encino, California, United States
Illinois Masonic Med Ctr / The Cancer Ctr
🇺🇸Chicago, Illinois, United States
Comprehensive Care Ctr
🇺🇸Dallas, Texas, United States
New York Univ Med Ctr
🇺🇸New York, New York, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Virginia Mason Research Center / Clinical Trial Unit
🇺🇸Seattle, Washington, United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources
🇺🇸Atlanta, Georgia, United States
Apogee Med Group
🇺🇸San Diego, California, United States
UCSF
🇺🇸San Francisco, California, United States
Dr Becky Miller
🇺🇸Los Angeles, California, United States
Northwestern Med Faculty Foundation
🇺🇸Chicago, Illinois, United States
Rush Presbyterian Med College
🇺🇸Chicago, Illinois, United States