Clinical Trials Directory

Trials / Completed

CompletedNCT00098943

NGR-TNF in Treating Patients With Advanced Solid Tumors

Phase I Trial of NGR-TNF Administered Every 3 Weeks as a 1 Hour Intravenous Infusion in Patients With Solid Tumor

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
70 (actual)
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCNGRC peptide-TNF alpha conjugate

Timeline

Start date
2004-09-01
Primary completion
2007-11-01
First posted
2004-12-09
Last updated
2012-09-24

Locations

2 sites across 2 countries: Germany, Netherlands

Source: ClinicalTrials.gov record NCT00098943. Inclusion in this directory is not an endorsement.