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.
Completed · Phase 3
Conditions studied: Sarcoma, Kaposi, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002093
- Run by
- Nexstar Pharmaceuticals
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- HIV infection.
- Advanced Kaposi's sarcoma.
- Prior Medication:
- Allowed:
- Prior intralesional vinblastine.
You may not qualify if…
- 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).
Where it is running
- 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
Full record on ClinicalTrials.gov
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