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.

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ClinicalTrials.gov Identifier: NCT00002093

Recruitment Status : Completed

First Posted : August 31, 2001

Last Update Posted : June 24, 2005

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

Study Description

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


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.

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Kaposi Sarcoma Soft Tissue Sarcoma

Drug Information available for: Vincristine sulfate Bleomycin sulfate Bleomycin Daunorubicin Daunorubicin hydrochloride

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Kaposi Sarcoma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002093

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

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 Key Record Dates
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

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