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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496535
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : February 23, 2012
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Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Head and Neck Neoplasms Drug: TNFerade biologic Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
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 the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. locoregional control at 24 months

Secondary Outcome Measures :
  1. 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.

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00496535

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

Responsible Party: Paul Fischer, PhD, GenVec Identifier: NCT00496535     History of Changes
Other Study ID Numbers: GV-001.011
GV-001.011 (TNF-CORE)
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: May 2011

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