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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Head and Neck Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

locoregional control at 24 months

Principal Investigator

Everett Vokes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Study Principal Investigator

Authority:

United States: Food and Drug Administration

Study ID:

GV-001.011

NCT ID:

NCT00496535

Start Date:

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • head
  • neck
  • cancer
  • neoplasm
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location

University of ChicagoChicago, Illinois  60637