A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma

Launched by SEQUUS PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy 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 infections except with potentially myelotoxic chemotherapy.
• • Foscarnet or ganciclovir for CMV infection.
• • Colony stimulating factors and erythropoietin.
• Patients must have:
• • Moderate to severe AIDS-related Kaposi's sarcoma.
• • Documented anti-HIV antibody.
• • No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
• NOTE:
• • Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Clinically significant cardiac disease.
• • Confusion or disorientation.
• Concurrent Medication:
• Excluded:
• • Other cytotoxic cancer chemotherapy.
• Patients with the following prior conditions are excluded:
• • Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function.
• • History of idiosyncratic or allergic reaction to anthracyclines.
• • History of major psychiatric illness.
• Prior Medication:
• Excluded within the past 4 weeks:
• • Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol).
• • Interferon treatment.
• Prior Treatment:
• Excluded within the past 3 weeks:
• • Radiation or electron beam therapy.