Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma

Completed · Phase 3

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002105

Run by

Sequus Pharmaceuticals

People needed

220

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• NOTE:
• Patients who fail the BV combination or who relapse are eligible to enter the Liposome Technology open trial using DOX-SL alone.

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:
• 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.

Where it is running

• Beth Israel Hosp — Boston, Massachusetts, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Twelve Oaks Hosp — Houston, Texas, United States
• Virginia Mason Research Center / Clinical Trial Unit — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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