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

Tracking Information

First Received Date ^ICMJE

June 28, 2007

Last Updated Date

February 22, 2012

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00496236 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Head and Neck Cancer
Head and Neck Neoplasms

Intervention ^ICMJE

Drug: TNFerade biologic

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00496236

Other Study ID Numbers ^ICMJE

GV-001.010, GV-001.010 (TNF-ELF)

Has Data Monitoring Committee

Not Provided

Responsible Party

Paul Fischer, PhD, GenVec

Study Sponsor ^ICMJE

GenVec

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Everett Vokes,, MD

University of Chicago

Information Provided By

GenVec

Verification Date

May 2011

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

To Top