(AMC 011) COL 3 IN PATIENTS WITH HIV RELATED KAPOSI'S SARCOMA

$0M01FY2000RRNIH

Boston University Medical Campus, Boston MA

Investigators

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Abstract

This is an open-label Phase I study of col-3 in people with HIV-related Kaposi's Sarcoma, which does not require chemotherapy. This study is sponsored by AIDS Malignancies Consortium (AMC) through the NCI in collaboration with CollaGenex Pharmaceuticals. Patients will be sequentially enrolled on 1 of 5 dose levels: 50, 70, 98, 137, and 192 mg/m2 given orally once daily, continuing until disease progression occurs. Dose escalations will occur after a minimum of 3 patients have completed 28 days of therapy without dose limiting toxicity. No intrapatient dose escalation will be allowed. Patients will be followed for safety and toxicity as well as anti-tumor response and survival. Extensive pharmacokinetic sampling will be done on study days 1 and 29. In addition, serial T cell subsets, HIV RNA, vascular endothelial growth factor (VEGF), basic fibroblast growth factor (BFGF), MMP-2 and MMP-9 levels will be followed. Patients will continue on study as along as their KS is stable and continuing to respond to col-3. Col-3 will be stopped if the subject develops tumor progression, unacceptable toxicity or develops one of the protocol defined reasons for treatment discontinuation.

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