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

This study has been completed.
Sponsor:
Information provided by:
GenVec
ClinicalTrials.gov Identifier:
NCT00496236
First received: June 28, 2007
Last updated: February 22, 2012
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Head and Neck Cancer
Head and Neck Neoplasms
 Drug: TNFerade biologic
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 NLM:

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

Further study details as provided by GenVec:

Primary Outcome Measures:
  • 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:
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496236

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
GenVec
Investigators
Principal Investigator: Everett Vokes,, MD University of Chicago
  More Information

No publications provided

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)
Study First Received: June 28, 2007
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GenVec:
head
neck
cancer
neoplasm

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Cetuximab
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013