Colorectal Cancer Clinical Trial
Official title:
Phase I Trial of NGR-TNF Administered Every 3 Weeks as a 1 Hour Intravenous Infusion in Patients With Solid Tumor
RATIONALE: Targeted therapy with tumor necrosis factor combined with a fusion protein may
stop the growth of solid tumors by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of NGR-TNF in
treating patients with advanced solid tumors.
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of tumor
vasculature-targeted tumor necrosis factor alpha (NGR-TNF) in patients with advanced
solid tumors.
- Determine the recommended phase II dose of this drug in these patients.
Secondary
- Determine the mechanism of action of this drug in these patients.
- Determine response in patients treated with this drug.
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.
Patients receive tumor vasculature-targeted tumor necrosis factor alpha (NGR-TNF) IV over 1
hour on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or
disease progression.
Cohorts of 1-6 patients receive escalating doses of NGR-TNF until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity. Up to 12 patients receive treatment at the MTD.
Patients are followed every 8 weeks until disease progression or the start of a new
anticancer treatment.
PROJECTED ACCRUAL: A total of 1-30 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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