|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098943 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Head and Neck Cancer Kidney Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Biological: CNGRC peptide-TNF alpha conjugate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2004 |
| Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of advanced solid tumor not amenable to any clinical improvement by current standard treatments
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Germany | |
| University Medical Center Hamburg - Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Netherlands | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Investigator: | Cornelis J. A. Punt, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
More Information
| Study ID Numbers: | CDR0000396507, EORTC-16041, MOLMED-EORTC-16041, EUDRACT-2004-000950-21 |
| Study First Received: | December 8, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00098943 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific stage IV renal cell cancer recurrent renal cell cancer stage IV colon cancer recurrent colon cancer anaplastic thyroid cancer insular thyroid cancer thyroid gland medullary carcinoma stage IV follicular thyroid cancer stage IV papillary thyroid cancer recurrent thyroid cancer recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the nasopharynx |
recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent verrucous carcinoma of the larynx recurrent verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the larynx recurrent adenoid cystic carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity recurrent basal cell carcinoma of the lip |
|
Urinary Tract Neoplasm Laryngeal Carcinoma Gastrointestinal Diseases Thyroid Cancer, Papillary Thyroid Cancer, Medullary Colonic Diseases Urogenital Neoplasms Squamous Cell Carcinoma Urologic Neoplasms Rectal Diseases Hypopharyngeal Cancer Renal Cancer Carcinoma, Adenoid Cystic Urologic Diseases Thyroid Cancer, Follicular |
Kidney Neoplasms Thyroid Cancer, Anaplastic Kidney Diseases Papilloma Salivary Gland Diseases Adenocarcinoma, Follicular Kidney Cancer Carcinoma, Medullary Nasopharyngeal Carcinoma Digestive System Neoplasms Thyroid Neoplasms Carcinoma, Basal Cell Intestinal Diseases Granuloma Recurrence |
|
Digestive System Neoplasms Neoplasms by Histologic Type Gastrointestinal Diseases Colonic Diseases Urogenital Neoplasms Intestinal Diseases Urologic Neoplasms Rectal Diseases Intestinal Neoplasms Carcinoma Neoplasms |
Digestive System Diseases Neoplasms by Site Urologic Diseases Kidney Neoplasms Head and Neck Neoplasms Carcinoma, Renal Cell Gastrointestinal Neoplasms Kidney Diseases Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |