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 Research Study 
i; 
STUDY NUMBER CONTINUATION: page^of pages. J 
Additional tests may be required depending upon your state of health and prior therapies. The 
blood tests will also include a test for the HIV (AIDS) virus. Women of childbearing age will also 
have a pregnancy test. Patients with HIV and pregnant women will not be eligible for this protocol. 
An MRI scan of your brain will be done. MRI is designed to examine the changes in 
the nervous system that occur with the recurrence of the brain tumor. MRI is a new diagnostic tool |j 
that uses a strong magnetic field and radio waves to show structural and chemical changes in the 
brain tissues. This technique has been found more sensitive than x-rays to detect a variety of 
processes within the brain. In addition, MRI has the advantage of not using radiation. During the MRIt 
study, a needle will be placed into a vein in your arm and an image-enhancing dye, gadolinium, will 
be administered through that vein before obtaining a second set of scans. Each scan takes about 60 ( 
to 90 minutes. The results of this initial MRI scan will determine the exact type of experimental 
treatment that we will consider and will allow us to compare the effects of therapy by repeating the 
MRI scan after we have begun the gene therapy treatments. 
Procedures: 
The size and location of your tumor(s) is such that partial surgical removal is possible. 
Therefore, you will undergo 3 procedures in the following order: (1) direct injection of the TK cells 
into the tumor by stereotaxic surgery, (2) brain surgery to remove as much of the tumor as possible 
and (3) administration of the drug Cytovene. 
You will have the direct implantation of the TK-producer cells using stereotaxic surgery to help us 
learn about gene transfer within the tumor and to begin gene transfer of the TK gene into the tumor. 
Seven days later you will have open surgery to remove the tumor and to insert more TK producer 
cells into the walls of the tumor cavity. The tumor will be taken to the laboratory for studies to 
establish the number of tumor cells that contain the new gene. 
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PATIENT IDENTIFICATION 
[ 840 ] 
CONTINUATION SHEET for either 
NIH-2514-1 (10-84) 
Recombinant DNA Research, Volume 15 
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