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

Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sarcoma, Kaposi; HIV Infections

Intervention: Doxorubicin hydrochloride (liposomal) (Drug); Bleomycin sulfate (Drug); Vincristine sulfate (Drug); Doxorubicin hydrochloride (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Sequus Pharmaceuticals

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.

Clinical Details

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

Study design: Treatment, Parallel Assignment, Safety Study

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

- 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.

Locations and Contacts

UCSF - San Francisco Gen Hosp, San Francisco, California 94110, United States

Kaiser Permanente Med Ctr, San Francisco, California 94115, United States

Dr Becky Miller, Los Angeles, California 90048, United States

Pacific Oaks Med Group, Beverly Hills, California 90211, United States

Hematology - Oncology Med Group of San Fernando Valley, Encino, California 91436, United States

Apogee Med Group, San Diego, California 92103, United States

San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States

UCSF, San Francisco, California 94117, United States

UCSF, San Francisco, California 941430324, United States

Pacific Oaks Med Group, Sherman Oaks, California 91403, United States

East Bay AIDS Ctr, Berkeley, California 94705, United States

Dr Mahmoud Mustafa, Washington, District of Columbia 20037, United States

Univ of Miami School of Medicine, Miami, Florida 33136, United States

H Lee Moffit Cancer Ctr and Research Institute, Tampa, Florida 33612, United States

American Med Research Institute, Atlanta, Georgia 30329, United States

Infectious Disease Rsch Consortium of GA / SE Clin Resources, Atlanta, Georgia 30345, United States

Rush Presbyterian Med College, Chicago, Illinois 60612, United States

Illinois Masonic Med Ctr / The Cancer Ctr, Chicago, Illinois 60657, United States

Northwestern Med Faculty Foundation, Chicago, Illinois 60611, United States

Henry Ford Hosp, Detroit, Michigan 48202, United States

Washington Univ, St. Louis, Missouri 63108, United States

Roswell Park Cancer Institute, Buffalo, New York 14263, United States

New York Univ Med Ctr, New York, New York 10016, United States

Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10023, United States

Saint Vincent's Hosp and Med Ctr, New York, New York 10011, United States

Graduate Hosp / Tuttleman Cancer Ctr, Philadelphia, Pennsylvania 19146, United States

Comprehensive Care Ctr, Dallas, Texas 75235, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Additional Information

Related publications:

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.


Last updated: June 23, 2005

Page last updated: June 20, 2008

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