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NGR-TNF in Treating Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.

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
Drug: CNGRC peptide-TNF alpha conjugate
Phase I

MedlinePlus related topics:   Cancer    Colorectal Cancer    Head and Neck Cancer    Kidney Cancer    Thyroid Cancer   

ChemIDplus related topics:   Parathyroid    Thyroid    Tumor Necrosis Factors    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   30
Study Start Date:   September 2004
Estimated Primary Completion Date:   January 2008 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of advanced solid tumor not amenable to any clinical improvement by current standard treatments

    • Preferably tumors well known to be very angiogenic (e.g., renal, colon, thyroid, and head and neck cancers)
  • No clinical signs of CNS involvement

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2 OR
  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and/or ALT < 2.5 times ULN (5 times ULN in the presence of liver metastases)

Renal

  • Creatinine < 1.5 times ULN

Cardiovascular

  • Cardiac function normal
  • No uncontrolled hypertension
  • No condition in which hypovolemia and its consequences (e.g., increased stroke volume, elevated blood pressure) or hemodilution could represent a risk to the patient

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active or uncontrolled systemic infection
  • No other uncontrolled disease, serious illness, or medical condition that would preclude study participation
  • No known hypersensitivity/allergic reaction to human albumin preparations or any of the excipients
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 28 days since prior immunotherapy

Chemotherapy

  • At least 28 days since prior chemotherapy and recovered

Endocrine therapy

  • At least 28 days since prior hormonal therapy

Radiotherapy

  • At least 28 days since prior radiotherapy and recovered
  • No prior radiotherapy to > 25% of bone marrow reserve

Surgery

  • More than 2 weeks since prior surgery

Other

  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098943

Locations
Germany
University Medical Center Hamburg - Eppendorf    
      Hamburg, Germany, D-20246
Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen    
      Nijmegen, Netherlands, NL-6500 HB

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Investigator:     Cornelis J. A. Punt, MD, PhD     Universitair Medisch Centrum St. Radboud - Nijmegen    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Van Laarhoven H, Fiedler W, Desar IM, et al.: Phase I and DCE-MRI evaluation of NGR-TNF, a novel vascular targeting agent, in patients with solid tumors (EORTC 16041). [Abstract] J Clin Oncol 26 (Suppl 15): A-3521, 2008.
Heerschap A, Fiedler W, Marreaud S, et al.: A phase I study of NGR-TNF, a novel vascular targeting agent, in patients with refractory solid tumors (EORTC 16041). [Abstract] J Clin Oncol 25 (Suppl 18): A-14074, 2007.
van Herpen C, Fiedler W, Marreaud S, et al.: A biological and pharmacologic phase I study of NGR-TNF, a novel vascular targeting agent, in patients with refractory solid tumors (EORTC 16041). [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-B78, 2007.
van Herpen C, Fiedler W, Toma S, et al.: Phase I study of NGR-TNF, a novel vascular targeting agent, in patients with refractory solid tumours (EORTC 16041). [Abstract] European Journal of Cancer Supplements 4 (12): A-366, 113, 2006.

Study ID Numbers:   CDR0000396507, EORTC-16041, MOLMED-EORTC-16041, EUDRACT-2004-000950-21
First Received:   December 8, 2004
Last Updated:   August 15, 2008
ClinicalTrials.gov Identifier:   NCT00098943
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Gastrointestinal Diseases
Squamous cell carcinoma
Colonic Diseases
Sodium Salicylate
Urogenital Neoplasms
Kidney cancer
Urologic Neoplasms
Rectal Diseases
Adenoid cystic carcinoma
Carcinoma, Adenoid Cystic
Urologic Diseases
Kidney Neoplasms
Thyroid cancer, medullary
Carcinoma, squamous cell
Laryngeal carcinoma
Kidney Diseases
Papilloma
Salivary Gland Diseases
Thyroid cancer, anaplastic
Adenocarcinoma, Follicular
Carcinoma, Medullary
Digestive System Neoplasms
Thyroid Neoplasms
Salicylsalicylic acid
Carcinoma, Basal Cell
Renal cancer
Intestinal Diseases
Granuloma
Recurrence
Intestinal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 04, 2008




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