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| Sponsored by: |
Nexstar Pharmaceuticals |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002093 |
Purpose
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 | Intervention | Phase |
|
Sarcoma, Kaposi HIV Infections |
Drug: Daunorubicin (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride |
Phase III |
| MedlinePlus related topics: | AIDS Kaposi's Sarcoma Soft Tissue Sarcoma |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Daunorubicin hydrochloride Daunorubicin Vincristine sulfate Vincristine Bleomycin Bleomycin sulfate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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. |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 7 days prior to study entry:
Contacts and 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 | |||||
| Saint Francis Mem Hosp | |||||
| San Francisco, California, United States, 94109 | |||||
| Desert Hosp Comprehensive Cancer Ctr | |||||
| Palm Springs, California, United States, 92262 | |||||
| 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 | |||||
| Nexstar Pharmaceuticals |
More Information
|
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)
  |
| Study ID Numbers: | 121A, 103-09 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002093 |
| Health Authority: | United States: Food and Drug Administration |
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