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 
STUDY NUMBER CONTINUATION: page 3 0 f^p396S- 
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 
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 MRI 
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: 
Because of the size and location of your tumor(s) it is not safe to remove the tumor(s) by open 
surgery on your brain. Therefore, you will receive two procedures in the following order: (1) direct 
injection of the TK cells into the brain tumor by stereotaxic surgery and (2) administration of the drug 
Cytovene®. 
Stereotaxic suraerv : will be performed under general anesthesia. It uses a special frame 
connected to the skull with small screws. This frame holds the needle used for injection in a precise 
set of coordinates to make certain that the injection(s) are inserted directly into the tumor. Then, 
using an MRI scanner, the exact location and coordinates of the tumor within the brain can be 
calculated by a computer to allow the stereotaxic frame, MRI and neurosurgeon to guide the needle 
into the proper location(s). Under local anesthesia, the stereotaxic frame will be applied to your 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either 
NIH-2514-1 (10-84) 
Recombinant DNA Research, Volume 15 
[825] 
