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A Phase I/II Safety, Tolerability and "Proof of Concept" Study of Radiotherapy, Cetuximab, and Intratumoral Injections of TNFerade™ Biologic (AdGVEGR.TNF.11D) for Elderly or Frail Patients or Intermediate Stage Patients With 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 Radiotherapy, Cetuximab, and Intratumoral Injections of TNFerade™ Biologic (AdGVEGR.TNF.11D) for Elderly or Frail Patients or Intermediate Stage Patients With Head and Neck Cancer


Inclusion Criteria:



- Age 70 or older with an ECOG performance status 0-2,or

- Patients > 18 years of age with ECOG performance status of 2 or greater, or

- Patients > 18 years of age unsuitable for concurrent chemotherapy or surgery due to:

- Renal failure, or

- Severe cardiopulmonary disease, or

- Other end-organ dysfunction that precludes the use of chemotherapy but does not
preclude the administration of TNFerade™ Biologic or cetuximab

- Tumor that is unresectable or inoperable and not amenable to regular concurrent
chemoradiotherapy

- Patients > 18 years of age with intermediate stage disease, stages II-III (T2-T3,
N0-1MO) carcinoma of the head and neck, including oral cavity, pharynx larynx,
paranasal sinuses and cervical esophagus. Selected patients with stage IV disease
(T4N0-1M0) will also be considered for enrollment. Therapy is given with curative
intent.

- Disease should be clinically accessible (measurable or evaluable) to keep injection
via direct intratumoral injection

- Informed consent

Exclusion Criteria:

- History of malignancy 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

- Overt systemic metastatic disease

- Previous radiation or chemotherapy for malignancy of the head and neck

- Clinical evidence of active infection of any type

- pregnant or lactating women

- Experimental medications within the last 4 weeks prior to Day 1

- Chronic treatment for greater than 6 months with steroids at doses above 10 mg/day
prednisone (or equivalent)

- Patients receiving hormone replacement therapy or hormonal contraceptives within 2
weeks of day 1

- Patients who have undergone surgery within the last 1 month

- Allergic reaction to cetuximab

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:

The maximum tolerated dose established in the Phase I (dose-finding) portion of the study will be used to assess the investigational drug's ability to enhance clinical outcome. The primary endpoint being locoregional control rate at 24 months.

Principal Investigator

Everett Vokes,, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

GV-001.010

NCT ID:

NCT00496236

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