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
18 Years
N/A
Both
Head and Neck Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, Head and Neck Neoplasms, Carcinoma of the Head and Neck
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
VCL-1005-207
NCT ID:
NCT00050388
Start Date:
Completion Date:
June 2002
Related Keywords:
- Head and Neck Cancer
- Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
- Head and Neck Neoplasms
- Carcinoma of the Head and Neck
- 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
- Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Louisiana State University | New Orleans, Louisiana 70112-2282 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| University of Michigan Medical Center | Ann Arbor, Michigan 48104-0914 |
| Henry Ford Health System | Detroit, Michigan 48202 |
| Case Western Reserve University | Cleveland, Ohio 44106 |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
| University of Chicago | Chicago, Illinois 60637 |
| University of Alabama, Birmingham | Birmingham, Alabama 35233 |
| University Cincinnati Medical Center | Cincinnati, Ohio 45267 |
