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

June 28, 2007
February 22, 2012
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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.
The maximum tolerated dose established in the Phase I (dose-finding) portion of the study will be used to assess the investigational drug’s abilty to enhance clinical outcome. The primary endpoint being locoregional control rate at 24 months.
Complete list of historical versions of study NCT00496236 on ClinicalTrials.gov Archive Site
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.
Same as current
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Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Head and Neck Cancer
  • Head and Neck Neoplasms
Drug: TNFerade biologic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00496236
GV-001.010, GV-001.010 (TNF-ELF)
Not Provided
Paul Fischer, PhD, GenVec
GenVec
Not Provided
Principal Investigator: Everett Vokes,, MD University of Chicago
GenVec
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP