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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
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)

Phase: Phase 3

Status: Completed

Sponsored by: Sequus Pharmaceuticals


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.

Clinical Details

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

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

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.


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


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.


- 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


- 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.

Locations and Contacts

Beth Israel Hosp, Boston, Massachusetts 02215, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

Twelve Oaks Hosp, Houston, Texas 77074, United States

Virginia Mason Research Center / Clinical Trial Unit, Seattle, Washington 98101, United States

Additional Information

Related 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)

Last updated: June 23, 2005

Page last updated: August 23, 2015

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