MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical 
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Research Study 
STUDY NUMBER CONTINUATION: page 2 of pages. 
What is genetic therapy for brain tumors? 
We will attempt to change the genetic material of your brain tumor cells by inserting the TK 
gene into the tumor cells. The way we will transport the TK gene into the tumor cells is to use a 
“vehicle” to carry the TK gene into the cells. An example is that if you want to move a caboose you 
need to hook it to an engine. The vehicle (or engine) in this case is another virus - a mouse virus - 1 
that has been inactivated so that it can not cause disease. We call this vehicle a “disabled mouse 
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vector”. We attach the TK gene (the caboose) to the vector and it carries the gene into your brain 
tumor cells. When the vector/gene combination gets into your tumor cells it inserts itself into the 
cells’ genetic material (chromosomes) and tells the tumor cells to begin making thymidine kinase. 
When we give you Cytovene , the tumor cells containing the TK gene make harmful substances 
within themselves that cause the tumor cells to die. We do not expect normal brain cells to be 
injured because the vector/gene combination is attracted only to rapidly growing cells. Normal cells 
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are not rapidly growing but tumor cells are and are therefore targets for the vector/gene 
combination. 
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Pretreatment Evaluation 
You will be admitted to the hospital for approximately 2-4 weeks. You will have a complete 
neurological and physical examination, blood, and urine tests to determine your overall physical 
health. The amount of blood drawn from you will be no more than three ounces in one day and will 
not exceed one pint over your stay at the hospital. You may experience some discomfort or 
temporary pain at the site of the needle entry for the routine blood studies. There is remote risk of 
fainting and local infection. 
You will also have x-rays of your chest and head and any other areas of the body as 
indicated by your medical examination and history. An electrocardiogram will be performed. 
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PATIENT 
IDENTIFICATION 
CONTINUATION SHEET for either 
[824] 
NIH-2514-1 (10-84) 
Recombinant DNA Research, Volume 15 
