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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002105
• Other study ID #: 134B
• Secondary ID: LTI-30-11
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Doxorubicin hydrochloride (liposomal)

• Bleomycin sulfate

• Vincristine sulfate

Locations

Country	Name	City	State
United States	Beth Israel Hosp	Boston	Massachusetts
United States	Twelve Oaks Hosp	Houston	Texas
United States	Mount Sinai Med Ctr	New York	New York
United States	Virginia Mason Research Center / Clinical Trial Unit	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sequus Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)