This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer

This study has been completed.
Information provided by:
GenVec Identifier:
First received: July 2, 2007
Last updated: February 22, 2012
Last verified: May 2011
The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent head and neck cancer (RHNC). All chemoradiotherapy is administered on a "week-on/week-off" schedule. The primary objective of the second phase II is to determine the locoregional control rate at 24 months.

Condition Intervention Phase
Head and Neck Cancer Head and Neck Neoplasms Drug: TNFerade biologic Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Safety, Tolerability, and "Proof of Concept" Study of TNFerade™ Biologic in Combination With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) for Patients With Unresectable Recurrent Head and Neck Cancer

Resource links provided by NLM:

Further study details as provided by GenVec:

Primary Outcome Measures:
  • locoregional control at 24 months

Secondary Outcome Measures:
  • Locoregional control at 3, 6 and 12 months, as well as tumor response rate, progression-free survival at 3, 6, 12 and 24 months, and the rate of metastases at 3, 6, 12 and 24 months will also be assessed.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Head and neck cancer
  • Patients must have a locoregional tumor amenable to reirradiation with curative intent.
  • disease, or the majority of disease, should be accessible to injection via direct intratumoral injection
  • Life expectancy of greater than 12 weeks
  • Age > 18 years
  • ECOG performance status 0-1

Exclusion Criteria:

  • Metastatic disease
  • History of malignancy (other than head and neck cancer) in the last 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer, or localized early stage prostate cancer, with patients continually disease free, or cancers that are not felt to influence treatment for head and neck cancer and life expectancy of patient
  • Patients may not be receiving any other investigational agents currently or within the 4 weeks prior to study Day 1
  • Active infection of any type
  • Chronic treatment for greater than 6 months with steroids
  • Pregnant or lactating women
  • Patients with known history of cerebral vascular disease; stroke or TIA within the last 6 months
  • Patients with history of documented thrombosis (PE or DVT), or known coagulopathy or thrombophilia, or evidence of DVT / thromboembolic event upon enrollment
  • Patients receiving hormone replacement therapy or hormonal contraceptives within two weeks of day 1
  • Patients who have undergone surgery within the last 1 month prior to day 1
  • Patients with active carotid artery involvement or status post carotid artery graft / stenting
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00496535

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Principal Investigator: Everett Vokes, MD Study Principal Investigator
  More Information

Responsible Party: Paul Fischer, PhD, GenVec Identifier: NCT00496535     History of Changes
Other Study ID Numbers: GV-001.011
GV-001.011 (TNF-CORE)
Study First Received: July 2, 2007
Last Updated: February 22, 2012

Keywords provided by GenVec:

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antisickling Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors processed this record on August 21, 2017