Back to resultsA Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer
Primary Purpose
Head and Neck Cancer, Head and Neck Neoplasms
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TNFerade biologic
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring head, neck, cancer, neoplasm
Eligibility Criteria
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
Sites / Locations
- University of Chicago
Outcomes
Primary Outcome Measures
locoregional control at 24 months
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00496535
Brief Title
A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
GenVec
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Head and Neck Neoplasms
Keywords
head, neck, cancer, neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TNFerade biologic
Primary Outcome Measure Information:
Title
locoregional control at 24 months
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett Vokes, MD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer
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