NGR-TNF in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00098943|
Recruitment Status : Completed
First Posted : December 9, 2004
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Head and Neck Cancer Kidney Cancer Unspecified Adult Solid Tumor, Protocol Specific||Biological: CNGRC peptide-TNF alpha conjugate||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of NGR-TNF Administered Every 3 Weeks as a 1 Hour Intravenous Infusion in Patients With Solid Tumor|
|Study Start Date :||September 2004|
|Primary Completion Date :||November 2007|
- Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0
- Clinical response as measured by RECIST criteria
- Mechanism of action as measured by Dynamic Imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098943
|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|