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.
Sponsor:
Information provided by:
GenVec
ClinicalTrials.gov Identifier:
NCT00496535
First received: July 2, 2007
Last updated: February 22, 2012
Last verified: May 2011

July 2, 2007
February 22, 2012
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locoregional control at 24 months
Same as current
Complete list of historical versions of study NCT00496535 on ClinicalTrials.gov 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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Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00496535
GV-001.011, GV-001.011 (TNF-CORE)
Not Provided
Paul Fischer, PhD, GenVec
GenVec
Not Provided
Principal Investigator: Everett Vokes, MD Study Principal Investigator
GenVec
May 2011

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