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

• ClinicalTrials.gov Identifier: NCT00002105
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Sequus Pharmaceuticals
• Information provided by: NIH AIDS Clinical Trials Information Service

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sarcoma, Kaposi; HIV Infections	Drug: Doxorubicin hydrochloride (liposomal); Drug: Bleomycin sulfate; Drug: Vincristine sulfate	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 220 participants
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• 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

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Beth Israel Hosp

Boston, Massachusetts, United States, 02215

United States, New York

Mount Sinai Med Ctr

New York, New York, United States, 10029

United States, Texas

Twelve Oaks Hosp

Houston, Texas, United States, 77074

United States, Washington

Virginia Mason Research Center / Clinical Trial Unit

Seattle, Washington, United States, 98101

Sponsors and Collaborators

Sequus Pharmaceuticals

More Information

Publications:

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)

• ClinicalTrials.gov Identifier: NCT00002105
• Other Study ID Numbers: 134B; LTI-30-11
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Last Verified: January 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:

Vincristine; Sarcoma, Kaposi; Liposomes; Doxorubicin; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; Bleomycin; Drug Carriers

Additional relevant MeSH terms:

Sarcoma, Kaposi; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Virus Diseases; Herpesviridae Infections; DNA Virus Infections; Neoplasms, Vascular Tissue; Doxorubicin; Liposomal doxorubicin; Bleomycin; Vincristine; Antibiotics, Antineoplastic; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Phytogenic; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators