A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

Launched by SEQUUS PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 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 must agree to have one or more representative KS lesions biopsied.

Gender

ALL

Eligibility 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.
• • 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.