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.

NCT00002093 | Completed Phase 3

• 2 other identifiers: 121A103-09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 13

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.

Conditions

Sarcoma, Kaposi; HIV Infections

Keywords

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

Interventions

Daunorubicin (liposomal) DRUG

Bleomycin sulfate DRUG

Vincristine sulfate DRUG

Doxorubicin hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have:
• HIV infection.
• Advanced Kaposi's sarcoma.
• Prior Medication:
• Allowed:
• Prior intralesional vinblastine.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nexstar Pharmaceuticals: lead

Study Sites (13)

Univ of Arizona / Arizona Cancer Ctr

Tucson, Arizona, 85724, United States

Location

Kenneth Norris Jr Cancer Hosp

Los Angeles, California, 90033, United States

Location

Desert Hosp Comprehensive Cancer Ctr

Palm Springs, California, 92262, United States

Location

Saint Francis Mem Hosp

San Francisco, California, 94109, United States

Location

Davies Med Ctr

San Francisco, California, 94114, United States

Location

Denver Gen Hosp

Denver, Colorado, 802044507, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Univ of Miami Dept of Medicine

Miami, Florida, 33136, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

New England Deaconess Hosp

Boston, Massachusetts, 02215, United States

Location

New York Univ Med Ctr

New York, New York, 10016, United States

Location

Kaiser Permanente Med Ctr

Portland, Oregon, 97227, United States

Location

Dr Edward Stool

Houston, Texas, 77004, United States

Location

Related Publications (2)

• 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. doi: 10.1200/JCO.1996.14.8.2353.

  PMID: 8708728 BACKGROUND

• 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)

  BACKGROUND

MeSH Terms

Conditions

Sarcoma, Kaposi; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Daunorubicin; Bleomycin; Vincristine; Doxorubicin

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1996-03

Locations

US (13)