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
Information provided by:

July 2, 2007
July 4, 2007
February 23, 2012
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locoregional control at 24 months
Same as current
Complete list of historical versions of study NCT00496535 on Archive Site
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.
Same as current
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A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer
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
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.
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Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Head and Neck Cancer
  • Head and Neck Neoplasms
Drug: TNFerade biologic
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
GV-001.011 (TNF-CORE)
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Paul Fischer, PhD, GenVec
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Principal Investigator: Everett Vokes, MD Study Principal Investigator
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP