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

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 I Phase II

MedlinePlus related topics:

Cancer Head and Neck Cancer

ChemIDplus related topics:

Hydroxyurea Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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

Contacts


Contact: Cindy Tinich	773-834-2058	ctinich@medicine.bsd.uchicago.edu

Locations


United States, Illinois
	University of Chicago	Recruiting
	Chicago, Illinois, United States, 60637
	Contact: Cindy Tinich, RN 773-834-2058 ctinich@medicine.bsd.uchicago.edu
	Principal Investigator: Tanguy Seiwert, MD

Sponsors and Collaborators

GenVec

Investigators


Principal Investigator:	Everett Vokes, MD	Study Principal Investigator

More Information

Study ID Numbers:	UCIRB #14733B, GV-001.011 (TNF-CORE)
First Received:	July 2, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00496535
Health Authority:	United States: Food and Drug Administration

Keywords provided by GenVec:

head

neck

cancer

neoplasm

Study placed in the following topic categories:

Hydroxyurea

Fluorouracil

Head and Neck Neoplasms

Recurrence

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Antisickling Agents

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Hematologic Agents

Enzyme Inhibitors

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	GenVec
Information provided by:	GenVec
ClinicalTrials.gov Identifier:	NCT00496535