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

NCT ID: NCT00002105

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Detailed 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.

Conditions

Sarcoma, Kaposi; HIV Infections

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Interventions

Doxorubicin hydrochloride (liposomal)

Intervention Type: DRUG

Bleomycin sulfate

Intervention Type: DRUG

Vincristine sulfate

Intervention Type: DRUG

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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sequus Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

Beth Israel Hosp

Boston, Massachusetts, United States

Mount Sinai Med Ctr

New York, New York, United States

Twelve Oaks Hosp

Houston, Texas, United States

Virginia Mason Research Center / Clinical Trial Unit

Seattle, Washington, United States

Countries

United States

References

Stewart S, Jablonowski H, Goebel FD, L'Age M, Spittle M, Luthy R. Randomized comparative trial of DOXIL vs. Bleomycin and Vincristine in the treatment of AIDS-Related KS. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):27 (abstract no LBB6026)

Reference Type: BACKGROUND

Other Identifiers

LTI-30-11

Identifier Type: -

Identifier Source: secondary_id

134B

Identifier Type: -

Identifier Source: org_study_id