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

Sequus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Sarcoma, Kaposi; HIV Infections

Treatments: Drug: Doxorubicin hydrochloride (liposomal); Drug: Bleomycin sulfate; Drug: Vincristine sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002105

134B

LTI-30-11

Details and patient eligibility

About

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.

Full description

Patients are randomized to receive either DOX-SL or the BV combination. Infusions are given on day 1 and every 3 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients who respond to therapy will be followed every 2 months for up to 1 year. Patients must agree to have one or more representative KS lesions biopsied.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.