NCT00002318UnknownPhase 3
Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
Sequus Pharmaceuticals51 sites in 1 country225 target enrollmentStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 225
- Locations
- 51
Study Overview
Brief Summary
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •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.
- •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:
- •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:
- •Prior anthracycline therapy.
- •Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.
- •Prior Treatment:
- •Radiation or electron beam therapy within the past 3 weeks.
Investigators
Study Sites (51)
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