Non-Technical Abstract 
Brief General Terminology Abstract: Clinical Protocol for Modification of Tumor 
Suppressor Gene Expression in Head and Neck Squamous Cell Carcinoma (HNSCC) 
with an Adenovirus Vector Expressing Wildtype p53 
Principal Investigator Gary L. dayman, D.D.S., M.D. 
Individuals afflicted with squamous cell carcinoma of the head and neck have a disease 
process that not only severely affects their quality of life, but also ultimately leads to their 
death in over 50% of patients. Despite concerted efforts to improve survival with surgery, 
radiation therapy, and chemotherapy; survival has remained unchanged for over thirty years 
and approximately 90% of patients that succumb to these cancers do so due to recurrence in the 
head and neck region. Patients that have failed local/regionally with curative attempts of 
radiation with or without surgery (for advanced disease) predictably survive a median of six 
months. However, patients with recurrent head and neck cancer also exhibit readily accessible 
tumors that can be measured, treated, and biopsied without significant discomfort to the 
individual. This patient population is the focus of the development of a novel treatment strategy 
in head and neck cancer. 
The general purpose of this study will be to see whether a normal copy of a gene called 
p53 can be placed inside the patient's cancer cells and cause the cancer to grow more slowly or 
to stop growing. We propose to inject a defective virus that contains this p53 gene that will 
produce a normal human protein that functions as a tumor suppressor gene. This protein has 
been shown to cause the death of cancer cells, but not cause cell death of normal cells. The 
virus, similar to that which produces a common cold, has been altered so it cannot reproduce. 
There will be two groups of patients for this study. The first group has advanced 
recurrent cancer of the head and neck that cannot be surgically removed, whereas in the second 
group surgery is feasible but will not (in and of itself) cure the patients of their cancer. 
Patients will receive injections of the defective virus with the normal p53 gene vector three 
times weekly for two consecutive weeks. Prior to leaving the hospital, the patient will be 
checked to make sure that no vector can be identified in any body fluids. A second two week 
session of therapy, identical to the first, will be undertaken during the second month. For those 
patients with surgically removable cancers, surgery will be performed three days following 
their last vector injection. At the time of surgery and prior to the removal of tubes usually 
placed in surgery, vector with normal p53 gene will again be put into the surgical site. Those 
patients with cancers that cannot be removed will continue to receive vector with normal p53 
gene injections three times weekly for two weeks per month unless they should get sick, have a 
reaction to the injections, tumor continues to grow, or they decide to discontinue treatment. 
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Recombinant DNA Research, Volume 20 
