COL-3 may stop the growth of cancer by stopping blood flow to the tumor. Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
AIDS - Associated Malignancies Clinical Trials Consortium
Rockville, Maryland, United States
Overall response rate
Binomial proportions and their 95% confidence intervals will be used to estimate the overall response rate for each treatment group.
Time frame: Up to 6 years
Response duration
The Kaplan-Meier Method will be used to estimate the distribution of response duration for each treatment group.
Time frame: Up to 6 years
Frequency of adverse events and their severity
Will be tabulated to evaluate tolerance of each dose level in the treatment of AIDS-related Kaposi's Sarcoma.
Time frame: Up to 6 years
Time to response
The Kaplan-Meier Method will be used to estimate the distribution of time to response for each treatment group.
Time frame: Up to 6 years
Quality of life
Individual composite scores will be constructed. Repeated measures and an analysis of variance will be performed on the composite scores to evaluate changes with time. Mixed models will be applied to the analysis of the composite score.
Time frame: Up to 6 years
Relationship between clinical response and quantitative measures of KSHV/HHV8 and HIV viral load
These measures will be tested to determine if they are normally distributed. If the data are non-normal, the data will be transformed for analysis purposes. The logistic regression model will be used to assess the relationship between qualification of baseline levels of KSHV/HHV-8, HIV viral load and response. The proportional hazards model will be used to evaluate the relationship between the qualification of baseline KSHV/HHV8 and HIV viral load and time to progression, and response duration.
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Time frame: Up to 6 years