NGR-TNF in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Colorectal Cancer; Head and Neck Cancer; Kidney Cancer; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00098943
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2004-12-08
• Study First Submitted QC: 2004-12-08
• Study First Posted: 2004-12-09
• Primary Completion: 2007-11
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0

Secondary Outcome Measures

Name	Time	Method
Clinical response as measured by RECIST criteria
Mechanism of action as measured by Dynamic Imaging

Trial Locations

Locations (2)

Universitair Medisch Centrum St. Radboud - Nijmegen; 🇳🇱 Nijmegen, Netherlands

University Medical Center Hamburg - Eppendorf; 🇩🇪 Hamburg, Germany