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

GenVec

Status and phase

Completed

Phase 2

Phase 1

Conditions

Head and Neck Neoplasms

Head and Neck Cancer

Treatments

Drug: TNFerade biologic

Study type

Interventional

Funder types

Industry

Identifiers

NCT00496535

GV-001.011

GV-001.011 (TNF-CORE)

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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