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