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| Sponsor: | Sequus Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002105 |
Purpose
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma, Kaposi HIV Infections |
Drug: Doxorubicin hydrochloride (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate |
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 Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma |
| Estimated Enrollment: | 220 |
Patients are randomized to receive either DOX-SL or the BV combination. Infusions are given on day 1 and every 3 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 who respond to therapy will be followed every 2 months for up to 1 year. 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, Massachusetts | |
| Beth Israel Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| United States, Texas | |
| Twelve Oaks Hosp | |
| Houston, Texas, United States, 77074 | |
| United States, Washington | |
| Virginia Mason Research Center / Clinical Trial Unit | |
| Seattle, Washington, United States, 98101 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002105 History of Changes |
| Other Study ID Numbers: | 134B, LTI-30-11 |
| 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 |