A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma
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.
I. To determine the safety and toxicity of Col-3 at two different dose levels in HIV related
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Binomial proportions and their 95% confidence intervals will be used to estimate the overall response rate for each treatment group.
Up to 6 years
AIDS Associated Malignancies Clinical Trials Consortium
United States: Food and Drug Administration
|AIDS - Associated Malignancies Clinical Trials Consortium||Rockville, Maryland 20850|