Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
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ClinicalTrials.gov Identifier: NCT00002105 |
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections | Drug: Doxorubicin hydrochloride (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 220 participants |
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 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
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.
NOTE:
- Patients who fail the BV combination or who relapse are eligible to enter the Liposome Technology open trial using DOX-SL alone.
Exclusion Criteria
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:
- Cytotoxic chemotherapy or interferon therapy within the past 4 weeks.
- More than one prior cycle of bleomycin/vincristine at any time.
Prior Treatment:
Excluded:
- Radiation or electron beam therapy within the past 3 weeks.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002105
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 |
ClinicalTrials.gov Identifier: | NCT00002105 |
Other Study ID Numbers: |
134B LTI-30-11 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | January 1996 |
Vincristine Sarcoma, Kaposi Liposomes Doxorubicin |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome Bleomycin Drug Carriers |
Sarcoma, Kaposi Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Virus Diseases Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Doxorubicin Liposomal doxorubicin Bleomycin |
Vincristine Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |