A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002318
• Other study ID #: 134A
• Secondary ID: LTI-30-10
• Status: Active, not recruiting
• 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• 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.

• 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.

NOTE:

• 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:

Excluded:

• 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:

Excluded:

• Prior anthracycline therapy.

• Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.

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

• Doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	American Med Research Institute	Atlanta	Georgia
United States	Infectious Disease Rsch Consortium of GA / SE Clin Resources	Atlanta	Georgia
United States	East Bay AIDS Ctr	Berkeley	California
United States	Pacific Oaks Med Group	Beverly Hills	California
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Illinois Masonic Med Ctr / The Cancer Ctr	Chicago	Illinois
United States	Northwestern Med Faculty Foundation	Chicago	Illinois
United States	Rush Presbyterian Med College	Chicago	Illinois
United States	Comprehensive Care Ctr	Dallas	Texas
United States	Henry Ford Hosp	Detroit	Michigan
United States	Hematology - Oncology Med Group of San Fernando Valley	Encino	California
United States	Baylor College of Medicine	Houston	Texas
United States	Dr Becky Miller	Los Angeles	California
United States	Univ of Miami School of Medicine	Miami	Florida
United States	New York Univ Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Saint Vincent's Hosp and Med Ctr	New York	New York
United States	Graduate Hosp / Tuttleman Cancer Ctr	Philadelphia	Pennsylvania
United States	Apogee Med Group	San Diego	California
United States	Kaiser Permanente Med Ctr	San Francisco	California
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	UCSF	San Francisco	California
United States	UCSF	San Francisco	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	Pacific Oaks Med Group	Sherman Oaks	California
United States	Washington Univ	St Louis	Missouri
United States	H Lee Moffit Cancer Ctr and Research Institute	Tampa	Florida
United States	Dr Mahmoud Mustafa	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sequus Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. — View Citation