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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00020683
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Terminated
Phase	Phase 2
Start date	March 2003
Completion date	November 2009

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