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A Comparison of DOX-SL Versus...

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

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sarcoma, Kaposi HIV Infections

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Doxorubicin hydrochloride (liposomal)

Intervention Type DRUG

Bleomycin sulfate

Intervention Type DRUG

Vincristine sulfate

Intervention Type DRUG

Doxorubicin hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Locations

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East Bay AIDS Ctr

Berkeley, California, United States

Site Status

Pacific Oaks Med Group

Beverly Hills, California, United States

Site Status

Hematology - Oncology Med Group of San Fernando Valley

Encino, California, United States

Site Status

Dr Becky Miller

Los Angeles, California, United States

Site Status