Back to resultsPhase II Trial of Allovectin-7® for Head and Neck Cancer
Primary Purpose
Head and Neck Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, Head and Neck Neoplasms
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Allovectin-7®
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Cancer, Carcinoma, Neoplasm, Head cancer, Neck cancer, Tongue cancer, Lip cancer, Oral Cavity, Oropharynx, Pharynx, Larynx, Squamous Cell, Salivary Glands, Tumor, Lesion, Cancer treatment, Clinical trial, Allovectin-7®, Otorhinolaryngologic Neoplasm, Otolaryngologic Cancer, Gene therapy, Immunotherapy, Cancer research, Cancer vaccine, Cancer cells
Eligibility Criteria
In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria. You have been diagnosed with head and neck cancer (also called squamous cell carcinoma of the mouth) You have Stage I or Stage II disease (a single mouth tumor which has not spread to other areas of the body) Surgery to remove your tumor is recommended You have not received any prior therapy for head and neck cancer (e.g. radiation or chemotherapy) You are able to carry out your normal daily activities
Sites / Locations
- University of Alabama, Birmingham
- University of Arkansas for Medical Sciences
- H. Lee Moffitt Cancer Center & Research Institute
- University of Chicago
- Louisiana State University
- University of Michigan Medical Center
- Henry Ford Health System
- University Cincinnati Medical Center
- Case Western Reserve University
- University of Pennsylvania
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00050388
Brief Title
Phase II Trial of Allovectin-7® for Head and Neck Cancer
Official Title
Phase II Study of the Safety and Efficacy of Allovectin-7® Immunotherapy for the Treatment of Primary, Resectable Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
June 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Vical
4. Oversight
5. Study Description
Brief Summary
The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink head and neck tumors. The trial will also examine if treatment can boost the immune system and if this treatment can improve the time to disease progression.
Detailed Description
Treatment - If you take part in this trial you will be treated for about four weeks. You will receive an injection of Allovectin-7® by needle, directly into your tumor. This will be repeated 14 days later. The injections may be given in a doctor's office. A week later, you will undergo surgery to remove the tumor. Your tumor will be measured before Allovectin-7® treatment and before surgery to see if Allovectin-7® was effective in shrinking it. This will be done by general physical exams and scans (such as X-ray scans). There will also be tests on the removed tumor to see if Allovectin-7® helped to boost the immune system to attack the cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, Head and Neck Neoplasms, Carcinoma of the Head and Neck
Keywords
Cancer, Carcinoma, Neoplasm, Head cancer, Neck cancer, Tongue cancer, Lip cancer, Oral Cavity, Oropharynx, Pharynx, Larynx, Squamous Cell, Salivary Glands, Tumor, Lesion, Cancer treatment, Clinical trial, Allovectin-7®, Otorhinolaryngologic Neoplasm, Otolaryngologic Cancer, Gene therapy, Immunotherapy, Cancer research, Cancer vaccine, Cancer cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
Allovectin-7®
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.
You have been diagnosed with head and neck cancer (also called squamous cell carcinoma of the mouth)
You have Stage I or Stage II disease (a single mouth tumor which has not spread to other areas of the body)
Surgery to remove your tumor is recommended
You have not received any prior therapy for head and neck cancer (e.g. radiation or chemotherapy)
You are able to carry out your normal daily activities
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Louisiana State University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Trial of Allovectin-7® for Head and Neck Cancer
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