NGR-TNF in Treating Patients With Advanced Solid Tumors
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.
Head and Neck Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Biological: CNGRC peptide-TNF alpha conjugate
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of NGR-TNF Administered Every 3 Weeks as a 1 Hour Intravenous Infusion in Patients With Solid Tumor|
- Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0 [ Designated as safety issue: Yes ]
- Clinical response as measured by RECIST criteria [ Designated as safety issue: No ]
- Mechanism of action as measured by Dynamic Imaging [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|University Medical Center Hamburg - Eppendorf|
|Hamburg, Germany, D-20246|
|Universitair Medisch Centrum St. Radboud - Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Study Chair:||Cornelis J. A. Punt, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|