- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00496535
A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer
February 22, 2012 updated by: GenVec
A Phase I/II Safety, Tolerability, and "Proof of Concept" Study of TNFerade™ Biologic in Combination With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) for Patients With Unresectable Recurrent Head and Neck Cancer
The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent head and neck cancer (RHNC).
All chemoradiotherapy is administered on a "week-on/week-off" schedule.
The primary objective of the second phase II is to determine the locoregional control rate at 24 months.
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
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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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:
- Head and neck cancer
- Patients must have a locoregional tumor amenable to reirradiation with curative intent.
- disease, or the majority of disease, should be accessible to injection via direct intratumoral injection
- Life expectancy of greater than 12 weeks
- Age > 18 years
- ECOG performance status 0-1
Exclusion Criteria:
- Metastatic disease
- History of malignancy (other than head and neck cancer) 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
- Patients may not be receiving any other investigational agents currently or within the 4 weeks prior to study Day 1
- Active infection of any type
- Chronic treatment for greater than 6 months with steroids
- Pregnant or lactating women
- Patients with known history of cerebral vascular disease; stroke or TIA within the last 6 months
- Patients with history of documented thrombosis (PE or DVT), or known coagulopathy or thrombophilia, or evidence of DVT / thromboembolic event upon enrollment
- Patients receiving hormone replacement therapy or hormonal contraceptives within two weeks of day 1
- Patients who have undergone surgery within the last 1 month prior to day 1
- Patients with active carotid artery involvement or status post carotid artery graft / stenting
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 Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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locoregional control at 24 months
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Secondary Outcome Measures
Outcome Measure |
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Locoregional control at 3, 6 and 12 months, as well as tumor response rate, progression-free survival at 3, 6, 12 and 24 months, and the rate of metastases at 3, 6, 12 and 24 months will also be assessed.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Everett Vokes, MD, Study Principal Investigator
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
July 2, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- GV-001.011
- GV-001.011 (TNF-CORE)
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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