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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: Doxorubicin hydrochloride (liposomal)
* Drug: Bleomycin sulfate
* Drug: Vincristine sulfate
* Drug: Doxorubicin hydrochloride


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Doxorubicin hydrochloride (liposomal)|nan|
|Drug: Bleomycin sulfate|nan|
|Drug: Vincristine sulfate|nan|
|Drug: Doxorubicin hydrochloride|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vincristine, Sarcoma, Kaposi, Liposomes, Doxorubicin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Bleomycin, Drug Carriers