Spots Global Cancer Trial Database for A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
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Trial Identification
Brief Title: A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
Official Title: Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
Study ID: NCT00002318
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
East Bay AIDS Ctr, Berkeley, California, United States
Pacific Oaks Med Group, Beverly Hills, California, United States
Hematology - Oncology Med Group of San Fernando Valley, Encino, California, United States
Dr Becky Miller, Los Angeles, California, United States
Apogee Med Group, San Diego, California, United States
UCSF - San Francisco Gen Hosp, San Francisco, California, United States
Kaiser Permanente Med Ctr, San Francisco, California, United States
UCSF, San Francisco, California, United States
San Francisco Veterans Administration Med Ctr, San Francisco, California, United States
UCSF, San Francisco, California, United States
Pacific Oaks Med Group, Sherman Oaks, California, United States
Dr Mahmoud Mustafa, Washington, District of Columbia, United States
Univ of Miami School of Medicine, Miami, Florida, United States
H Lee Moffit Cancer Ctr and Research Institute, Tampa, Florida, United States
American Med Research Institute, Atlanta, Georgia, United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources, Atlanta, Georgia, United States
Northwestern Med Faculty Foundation, Chicago, Illinois, United States
Rush Presbyterian Med College, Chicago, Illinois, United States
Illinois Masonic Med Ctr / The Cancer Ctr, Chicago, Illinois, United States
Henry Ford Hosp, Detroit, Michigan, United States
Washington Univ, St Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Saint Vincent's Hosp and Med Ctr, New York, New York, United States
New York Univ Med Ctr, New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York, United States
Graduate Hosp / Tuttleman Cancer Ctr, Philadelphia, Pennsylvania, United States
Comprehensive Care Ctr, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Contact Details
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