A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
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ClinicalTrials.gov Identifier: NCT00002318 |
Recruitment Status : Unknown
Verified January 1996 by NIH AIDS Clinical Trials Information Service.
Recruitment status was: Active, not recruiting
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 Drug: Doxorubicin hydrochloride | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 225 participants |
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 |


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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.
- 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.
NOTE:
- Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, 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, 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.
- Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.
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): NCT00002318

ClinicalTrials.gov Identifier: | NCT00002318 |
Other Study ID Numbers: |
134A LTI-30-10 |
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 |