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

NCT00496535 | Completed Phase 1

• 2 other identifiers: GV-001.011GV-001.011 (TNF-CORE)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer; Head and Neck Neoplasms

Keywords

head; neck; cancer; neoplasm

Outcome Measures

Primary Outcomes (1)

• locoregional control at 24 months

Secondary Outcomes (1)

• 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.

Interventions

TNFerade biologic DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GenVec: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

• Everett Vokes, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 4, 2007
• Last Updated: February 23, 2012

Record last verified: 2011-05

Locations

US (1)