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Sponsored by: |
Sequus Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002318 |
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.
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Doxorubicin hydrochloride (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 225 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
United States, California | |
UCSF - San Francisco Gen Hosp | |
San Francisco, California, United States, 94110 | |
Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
Dr Becky Miller | |
Los Angeles, California, United States, 90048 | |
San Francisco Veterans Administration Med Ctr | |
San Francisco, California, United States, 94121 | |
Hematology - Oncology Med Group of San Fernando Valley | |
Encino, California, United States, 91436 | |
Apogee Med Group | |
San Diego, California, United States, 92103 | |
Pacific Oaks Med Group | |
Beverly Hills, California, United States, 90211 | |
UCSF | |
San Francisco, California, United States, 94117 | |
UCSF | |
San Francisco, California, United States, 941430324 | |
Pacific Oaks Med Group | |
Sherman Oaks, California, United States, 91403 | |
East Bay AIDS Ctr | |
Berkeley, California, United States, 94705 | |
United States, District of Columbia | |
Dr Mahmoud Mustafa | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 33136 | |
H Lee Moffit Cancer Ctr and Research Institute | |
Tampa, Florida, United States, 33612 | |
United States, Georgia | |
American Med Research Institute | |
Atlanta, Georgia, United States, 30329 | |
Infectious Disease Rsch Consortium of GA / SE Clin Resources | |
Atlanta, Georgia, United States, 30345 | |
United States, Illinois | |
Rush Presbyterian Med College | |
Chicago, Illinois, United States, 60612 | |
Illinois Masonic Med Ctr / The Cancer Ctr | |
Chicago, Illinois, United States, 60657 | |
Northwestern Med Faculty Foundation | |
Chicago, Illinois, United States, 60611 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
United States, Missouri | |
Washington Univ | |
St. Louis, Missouri, United States, 63108 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263 | |
New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Saint Luke's - Roosevelt Hosp Ctr | |
New York, New York, United States, 10023 | |
Saint Vincent's Hosp and Med Ctr | |
New York, New York, United States, 10011 | |
United States, Pennsylvania | |
Graduate Hosp / Tuttleman Cancer Ctr | |
Philadelphia, Pennsylvania, United States, 19146 | |
United States, Texas | |
Comprehensive Care Ctr | |
Dallas, Texas, United States, 75235 | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Study ID Numbers: | 134A, LTI-30-10 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002318 |
Health Authority: | United States: Food and Drug Administration |
Vincristine Sarcoma, Kaposi Liposomes Doxorubicin |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome Bleomycin Drug Carriers |
Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Vincristine Bleomycin Doxorubicin Soft tissue sarcomas Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Mitosis Modulators Antimitotic Agents Infection |
Antibiotics, Antineoplastic Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Lentivirus Infections Neoplasms, Vascular Tissue Antineoplastic Agents, Phytogenic |