A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma

PRIMARY OBJECTIVES: I. To evaluate the tumor response rate and response duration of treatment with Col-3 at two different dose levels- 50 mg/day and 100 mg/day in subjects with HIV related KS. II. To evaluate the biologic activity of Col-3 by measuring percent apoptotic cells on tumor biopsies pre- and post-treatment. III. To evaluate the effect of Col-3 on serum levels of MMP-2 and MMP-9. SECONDARY OBJECTIVES: I. To determine the safety and toxicity of Col-3 at two different dose levels in HIV related KS. II. To evaluate the effect of Col-3 on overall quality of life. III. To evaluate the relationship between clinical response and quantitative measures of KSHV/HHV-8 and HIV viral load. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive low-dose oral COL-3 once daily. Arm II: Patients receive high-dose oral COL-3 once daily. Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed. Patients are followed for at least 1 month. PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 1.75 years.