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.
NCT ID: NCT00002093
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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Daunorubicin (liposomal)
Bleomycin sulfate
Vincristine sulfate
Doxorubicin hydrochloride
Eligibility Criteria
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Inclusion Criteria
* HIV infection.
* Advanced Kaposi's sarcoma.
Prior Medication:
Allowed:
* Prior intralesional vinblastine.
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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Nexstar Pharmaceuticals
INDUSTRY
Locations
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Univ of Arizona / Arizona Cancer Ctr
Tucson, Arizona, United States
Kenneth Norris Jr Cancer Hosp
Los Angeles, California, United States
Desert Hosp Comprehensive Cancer Ctr
Palm Springs, California, United States
Saint Francis Mem Hosp
San Francisco, California, United States
Davies Med Ctr
San Francisco, California, United States
Denver Gen Hosp
Denver, Colorado, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Univ of Miami Dept of Medicine
Miami, Florida, United States
Northwestern Univ Med School
Chicago, Illinois, United States
New England Deaconess Hosp
Boston, Massachusetts, United States
New York Univ Med Ctr
New York, New York, United States
Kaiser Permanente Med Ctr
Portland, Oregon, United States
Dr Edward Stool
Houston, Texas, United States
Countries
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References
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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.
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)
Other Identifiers
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103-09
Identifier Type: -
Identifier Source: secondary_id
121A
Identifier Type: -
Identifier Source: org_study_id