Spots Global Cancer Trial Database for NGR-TNF in Treating Patients With Advanced Solid Tumors

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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