A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.

Study Description

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Brief Summary:

To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.

Condition or disease	Intervention/treatment	Phase
Sarcoma, Kaposi; HIV Infections	Drug: Daunorubicin (liposomal); Drug: Bleomycin sulfate; Drug: Vincristine sulfate; Drug: Doxorubicin hydrochloride	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Primary Purpose:	Treatment
Official Title:	A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

• HIV infection.
• Advanced Kaposi's sarcoma.

Prior Medication:

Allowed:

• Prior intralesional vinblastine.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Acute intercurrent infection other than genital herpes.
• Uncompensated cardiovascular, hepatic, renal, or pulmonary disease unrelated to Kaposi's sarcoma.
• Symptomatic peripheral neuropathy.
• Any condition that compromises ability to give informed consent or complete the study.

Concurrent Medication:

Excluded:

• Concurrent ganciclovir.

Patients with the following prior conditions are excluded:

• Symptomatic AIDS-defining opportunistic infection within 2 weeks of entry.
• History of malignancy other than Kaposi's sarcoma, basal cell carcinoma, or carcinoma in situ of the cervix.

Prior Medication:

Excluded:

• Prior systemic chemotherapy.
• Intralesional therapies within 7 days prior to study entry.
• Growth factors (G-CSF or GM-CSF), immune modifiers, or investigational agents within 14 days prior to study entry.
• Interferon preparations (alpha or beta) within 28 days prior to study entry.

Prior Treatment:

Excluded within 7 days prior to study entry:

• Radiation.
• Local therapies (e.g., cryotherapy).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Univ of Arizona / Arizona Cancer Ctr
Tucson, Arizona, United States, 85724
United States, California
Kenneth Norris Jr Cancer Hosp
Los Angeles, California, United States, 90033
Desert Hosp Comprehensive Cancer Ctr
Palm Springs, California, United States, 92262
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
Davies Med Ctr
San Francisco, California, United States, 94114
United States, Colorado
Denver Gen Hosp
Denver, Colorado, United States, 802044507
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Univ of Miami Dept of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Massachusetts
New England Deaconess Hosp
Boston, Massachusetts, United States, 02215
United States, New York
New York Univ Med Ctr
New York, New York, United States, 10016
United States, Oregon
Kaiser Permanente Med Ctr
Portland, Oregon, United States, 97227
United States, Texas
Dr Edward Stool
Houston, Texas, United States, 77004

Sponsors and Collaborators

Nexstar Pharmaceuticals

More Information

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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.

Savage GE, Gable C, Motte K, Dixon C, Becker R. A pharmacoeconomic analysis of Kaposi's sarcoma patients based on a clinical trial of ABV vs. DaunoXome. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):32 (abstract no LBB6048)

ClinicalTrials.gov Identifier:	NCT00002093 History of Changes
Other Study ID Numbers:	121A; 103-09
First Posted:	August 31, 2001
Last Update Posted:	June 24, 2005
Last Verified:	March 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:

Vincristine; Sarcoma, Kaposi; Liposomes; Doxorubicin	Acquired Immunodeficiency Syndrome; Bleomycin; Daunorubicin; Drug Carriers

Additional relevant MeSH terms:

HIV Infections; Sarcoma; Sarcoma, Kaposi; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Herpesviridae Infections	DNA Virus Infections; Neoplasms, Vascular Tissue; Doxorubicin; Liposomal doxorubicin; Daunorubicin; Bleomycin; Vincristine; Antibiotics, Antineoplastic; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Phytogenic; Tubulin Modulators