Protocol HNS 94—00 1 
REVISED 11/17/94 
Page 1 of 5 
THE UNIVERSITY OF TEXAS 
M. D. ANDERSON CANCER CENTER 
Protocol Title: Clinical Protocol for Modification of Tumor Suppressor Gene 
Expression in Head and Neck Squamous Cell Carcinoma (HNSCC) 
with an Adenovirus Vector Expressing Wild-type p53 
1 . 
Participant’s Name I.D. Number 
You have the right to know about the procedures that are to be used in your participation in 
clinical research so as to afford you an opportunity to make the decision whether or not to 
undergo the procedure after knowing the risks and hazards involved. This disclosure is not 
meant to frighten or alarm you; it is simply an effort to make you better informed so that 
you may give or withhold your consent to participate in clinical research. This informed 
consent does not supersede other consents you may have signed in other protocols. 
DESCRIPTION OF RESEARCH 
2. PURPOSE OF THE STUDY: Some cancers that occur in the head and neck area 
may be due to a defect in a gene called p53. The purpose of this clinical research 
study will be to see whether a normal copy of the p53 gene can be placed inside the 
patient’s cancer cells and cause the cancer to grow more slowly or to stop growing. 
3. DESCRIPTION OF RESEARCH: To introduce the normal p53 gene into tumor 
cells utilizing a defective virus of the adenovirus type which is similar to other 
viruses that cause the common cold. This defective virus is called a 'Vector”. These 
tumors will be injected directly with the adenovirus three times a week for two 
weeks. After two weeks of rest from receiving treatment, tumors will then be 
injected again with the virus three times a week for two consecutive weeks. If the 
tumor can be removed in its entirety, surgery will be performed for removal of 
tumor that is considered completely removable by the patient’s physician. Surgery 
must be performed within four days after completion of the last injection of virus. 
At the time of surgery, additional virus is placed into the area where the tumor has 
been removed. Tubing, which is ordinarily placed in surgical areas, is used to allow 
for drainage of fluids from the surgery area. Three days after the tumor has been 
removed, virus will be placed into the tubing and allowed to enter the surgical site 
once again. If the patient has undergone surgery, this will be the last treatment with 
adenovirus. 
If the cancer cannot be removed by the physician, this tumor will be injected directly 
r ,„. Recombinant DNA Research, Volume 20 
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