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Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00496236
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : February 23, 2012
Information provided by:

Brief Summary:
This study is looking at the safety and tolerability of TNFeradeä Biologic combined with conventional once daily radiation therapy in elderly or frail patients with new onset locally advanced head and neck tumors.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Head and Neck Neoplasms Drug: TNFerade biologic Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Locoregional control at 3,6, and 12 months, objective response rate, progression-free survival at 3,6,12, and 24 months, and the rate of distal metastases at 3,6, 12 and 24 months will also be assessed.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496236

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Principal Investigator: Everett Vokes,, MD University of Chicago

Responsible Party: Paul Fischer, PhD, GenVec
ClinicalTrials.gov Identifier: NCT00496236     History of Changes
Other Study ID Numbers: GV-001.010
GV-001.010 (TNF-ELF)
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: May 2011

Keywords provided by GenVec:

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents