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| Sponsor: | Sequus Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002318 |
Purpose
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: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations| United States, California | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| Pacific Oaks Med Group | |
| Beverly Hills, California, United States, 90211 | |
| Hematology - Oncology Med Group of San Fernando Valley | |
| Encino, California, United States, 91436 | |
| Dr Becky Miller | |
| Los Angeles, California, United States, 90048 | |
| Apogee Med Group | |
| San Diego, California, United States, 92103 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| UCSF | |
| San Francisco, California, United States, 941430324 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| UCSF | |
| San Francisco, California, United States, 94117 | |
| Pacific Oaks Med Group | |
| Sherman Oaks, California, United States, 91403 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002318 History of Changes |
| Other Study ID Numbers: | 134A, LTI-30-10 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Vincristine Sarcoma, Kaposi Liposomes Doxorubicin |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome Bleomycin Drug Carriers |
|
HIV Infections Acquired Immunodeficiency Syndrome Sarcoma, Kaposi AIDS-Related Opportunistic Infections Sarcoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections |
DNA Virus Infections Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Opportunistic Infections Infection Parasitic Diseases Bleomycin Doxorubicin Vincristine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |