A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
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
2 other identifiers
interventional
225
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
January 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
- Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
- Foscarnet for new episodes of cytomegalovirus infection.
- Colony-stimulating factors and erythropoietin.
- Patients must have:
- Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
- At least 25 mucocutaneous lesions.
- Ten or more new lesions in the prior month.
- Documented visceral disease with at least two accessible cutaneous lesions.
- Two accessible cutaneous lesions with edema.
- Documented anti-HIV antibody.
- No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
- Life expectancy \> 4 months.
- +2 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Clinically significant cardiac, hepatic, or renal disease.
- Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss.
- Inability to comply with the study.
- Concurrent Medication:
- Excluded:
- Other cytotoxic chemotherapy.
- Ganciclovir.
- Patients with the following prior conditions are excluded:
- Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
- History of idiosyncratic or allergic reaction to bleomycin or vincristine.
- Prior Medication:
- Excluded:
- Prior anthracycline therapy.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Pacific Oaks Med Group
Beverly Hills, California, 90211, United States
Hematology - Oncology Med Group of San Fernando Valley
Encino, California, 91436, United States
Dr Becky Miller
Los Angeles, California, 90048, United States
Apogee Med Group
San Diego, California, 92103, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
UCSF
San Francisco, California, 94117, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
UCSF
San Francisco, California, 941430324, United States
Pacific Oaks Med Group
Sherman Oaks, California, 91403, United States
Dr Mahmoud Mustafa
Washington D.C., District of Columbia, 20037, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
H Lee Moffit Cancer Ctr and Research Institute
Tampa, Florida, 33612, United States
American Med Research Institute
Atlanta, Georgia, 30329, United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, 30345, United States
Northwestern Med Faculty Foundation
Chicago, Illinois, 60611, United States
Rush Presbyterian Med College
Chicago, Illinois, 60612, United States
Illinois Masonic Med Ctr / The Cancer Ctr
Chicago, Illinois, 60657, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Washington Univ
St Louis, Missouri, 63108, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011, United States
New York Univ Med Ctr
New York, New York, 10016, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10023, United States
Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia, Pennsylvania, 19146, United States
Comprehensive Care Ctr
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (1)
Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. doi: 10.1200/JCO.1996.14.8.2353.
PMID: 8708728BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-01