Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
- 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.
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
- Life expectancy > 4 months.
- Patients who fail the BV combination or who relapse are eligible to enter the
Liposome Technology open trial using DOX-SL alone.
Patients with the following symptoms or conditions are excluded:
- Clinically significant cardiac disease.
- Confusion, disorientation, CNS symptoms, or peripheral neuropathy.
- Other cytotoxic chemotherapy.
- Colony-stimulating factors.
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
- History of major psychiatric illness.
- Cytotoxic chemotherapy or interferon therapy within the past 4 weeks.
- More than one prior cycle of bleomycin/vincristine at any time.
- Radiation or electron beam therapy within the past 3 weeks.