Back to resultsRadiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail 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:
- 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
Sites / Locations
- University of Chicago
Outcomes
Primary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00496236
Brief Title
Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GenVec
4. Oversight
5. Study Description
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.
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
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett Vokes,, MD
Organizational Affiliation
University of Chicago
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
Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer
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