Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
2 other identifiers
interventional
220
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
4 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.
- Maintenance therapy for tuberculosis, fungal, and herpes infections.
- Therapy for new episodes of tuberculosis, fungal, and herpes infection except with potentially myelotoxic chemotherapy.
- Foscarnet for cytomegalovirus infection.
- Erythropoietin.
- Patients must have:
- Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
- At least 15 mucocutaneous lesions.
- Six or more new lesions in the prior month.
- Documented visceral disease with at least five accessible cutaneous lesions.
- Documented anti-HIV antibody.
- No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if REQUIRING 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 disease.
- Confusion, disorientation, CNS symptoms, or peripheral neuropathy.
- Concurrent Medication:
- Excluded:
- Other cytotoxic chemotherapy.
- Colony-stimulating factors.
- 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 anthracyclines, bleomycin, or vincristine.
- History of major psychiatric illness.
- Prior Medication:
- Excluded:
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Beth Israel Hosp
Boston, Massachusetts, 02215, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Twelve Oaks Hosp
Houston, Texas, 77074, United States
Virginia Mason Research Center / Clinical Trial Unit
Seattle, Washington, 98101, United States
Related Publications (1)
Stewart S, Jablonowski H, Goebel FD, L'Age M, Spittle M, Luthy R. Randomized comparative trial of DOXIL vs. Bleomycin and Vincristine in the treatment of AIDS-Related KS. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):27 (abstract no LBB6026)
BACKGROUND
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