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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.

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sarcoma, Kaposi; HIV Infections

Intervention: Daunorubicin (liposomal) (Drug); Bleomycin sulfate (Drug); Vincristine sulfate (Drug); Doxorubicin hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Nexstar Pharmaceuticals


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.

Clinical Details

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.

Study design: Allocation: Randomized, Primary Purpose: Treatment


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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).

Locations and Contacts

Univ of Arizona / Arizona Cancer Ctr, Tucson, Arizona 85724, United States

Kenneth Norris Jr Cancer Hosp, Los Angeles, California 90033, United States

Desert Hosp Comprehensive Cancer Ctr, Palm Springs, California 92262, United States

Davies Med Ctr, San Francisco, California 94114, United States

Saint Francis Mem Hosp, San Francisco, California 94109, United States

Denver Gen Hosp, Denver, Colorado 802044507, United States

George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States

Univ of Miami Dept of Medicine, Miami, Florida 33136, United States

Northwestern Univ Med School, Chicago, Illinois 60611, United States

New England Deaconess Hosp, Boston, Massachusetts 02215, United States

New York Univ Med Ctr, New York, New York 10016, United States

Kaiser Permanente Med Ctr, Portland, Oregon 97227, United States

Dr Edward Stool, Houston, Texas 77004, United States

Additional Information

Related 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)

Last updated: June 23, 2005

Page last updated: August 23, 2015

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