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.
Overview
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.
Full Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Primary Purpose: Treatment
Interventions
- Drug: Daunorubicin (liposomal)
- Drug: Bleomycin sulfate
- Drug: Vincristine sulfate
- Drug: Doxorubicin hydrochloride
Participating in This Clinical Trial
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).
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Nexstar Pharmaceuticals
References
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)
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