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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496535

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

No publications provided

Responsible Party: Paul Fischer, PhD, GenVec
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Keywords provided by GenVec:
head
neck
cancer
neoplasm

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Fluorouracil
Hydroxyurea
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antisickling Agents
Hematologic Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013