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

February 22, 2012 updated by: GenVec

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenVec

Investigators

  • Principal Investigator: Everett Vokes,, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 28, 2007

First Submitted That Met QC Criteria

July 2, 2007

First Posted (ESTIMATE)

July 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GV-001.010
  • GV-001.010 (TNF-ELF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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