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Sponsored by: |
Vical |
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Information provided by: | Vical |
ClinicalTrials.gov Identifier: | NCT00050388 |
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.
Condition | Intervention | Phase |
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Head and Neck Cancer Squamous Cell Carcinoma of the Oral Cavity or Oropharynx Head and Neck Neoplasms Carcinoma of the Head and Neck |
Genetic: Allovectin-7® |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Study Completion Date: | June 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.
United States, Alabama | |
University of Alabama, Birmingham | |
Birmingham, Alabama, United States, 35233 | |
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Louisiana | |
Louisiana State University | |
New Orleans, Louisiana, United States, 70112 | |
United States, Michigan | |
University of Michigan Medical Center | |
Ann Arbor, Michigan, United States, 48109 | |
Henry Ford Health System | |
Detroit, Michigan, United States, 48202 | |
United States, Ohio | |
University Cincinnati Medical Center | |
Cincinnati, Ohio, United States, 45267 | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Study ID Numbers: | VCL-1005-207 |
Study First Received: | December 6, 2002 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00050388 History of Changes |
Health Authority: | United States: Food and Drug Administration |
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 |
Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Epidermoid Carcinoma Neoplasms, Squamous Cell Squamous Cell Carcinoma |
Carcinoma, Squamous Cell Salivary Gland Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Head and Neck Neoplasms |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |