Clinical Trial: NGR-TNF in Treating Patients With Advanced Solid Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I Trial of NGR-TNF Administered Every 3 Weeks as a 1 Hour Intravenous Infusion in Patients With Solid Tumor
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 Summary:
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.
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Current Primary Outcome: Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0
Original Primary Outcome:
Current Secondary Outcome:
- Clinical response as measured by RECIST criteria
- Mechanism of action as measured by Dynamic Imaging
Original Secondary Outcome:
Information By: European Organisation for Research and Treatment of Cancer - EORTC
Dates:
Date Received: December 8, 2004
Date Started: September 2004
Date Completion:
Last Updated: September 20, 2012
Last Verified: September 2012