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.

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002093
• Other study ID #: 121A
• Secondary ID: 103-09
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Daunorubicin (liposomal)

• Bleomycin sulfate

• Vincristine sulfate

• Doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	New England Deaconess Hosp	Boston	Massachusetts
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Denver Gen Hosp	Denver	Colorado
United States	Dr Edward Stool	Houston	Texas
United States	Kenneth Norris Jr Cancer Hosp	Los Angeles	California
United States	Univ of Miami Dept of Medicine	Miami	Florida
United States	New York Univ Med Ctr	New York	New York
United States	Desert Hosp Comprehensive Cancer Ctr	Palm Springs	California
United States	Kaiser Permanente Med Ctr	Portland	Oregon
United States	Davies Med Ctr	San Francisco	California
United States	Saint Francis Mem Hosp	San Francisco	California
United States	Univ of Arizona / Arizona Cancer Ctr	Tucson	Arizona
United States	George Washington Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Nexstar Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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)