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 
s 
STUDY NUMBER CONTINUATION: page 4 of pages. 
Stereotaxic surgery: 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 
head. You will then be taken to the MRI suite for an MRI scan with the stereotaxic frame in place so 
: the appropriate calculations can be made for the site(s) of injection. Following the MRI study, you 
will be taken to the operating room, and under general anesthesia, a small hole will be drilled in 
your skull. A thin, long needle connected to the stereotaxic frame will be guided to the tumor and 
the mouse producer cells will be slowly injected. This may be repeated at different sites in the tumor 
depending on the size of the tumor. Some injections may require more than one hole in the skull. 
The location and direction of the injection are calculated by a computer and are based on data 
generated from the MRI study. The calculations are made with the intent of minimizing any potential 
damage to important normal structures of the brain. Following surgery, you will be monitored in the 
Surgical Intensive Care Unit. 
I 
Ij 
Open surgery: Seven days later, after allowing time for the vector to insert the TK-gene into as 
many tumor cells as possible, you will be taken to the operating room and, following the 
administration of general anesthesia, a craniotomy (direct surgery on the brain) will be performed. 
A piece of skull will be removed, the coverings of the brain will be opened and as much as safely 
possible of the brain tumor will be removed. Since it is always impossible to completely remove a 
recurrent brain tumor, the remaining tumor and the brain immediately surrounding the tumor will be 
reinjected with the TK-producer cells during the operation. Following surgery, you will again be 
monitored in the Surgical Intensive Care Unit. During the various stages of therapy, you will receive 
various drugs to prevent convulsions and swelling within the brain. These drugs are used routinely 
in neurosurgery and are given to almost all patients who undergo brain tumor surgery. Antibiotics 
will also be given to you on each day of surgery. 
. 
PATIENT 
IDENTIFICATION 
CONTINUATION SHEET for either 
NIH-2514-1 (10-84) 
Recombinant DNA Research, Volume 15 
[841] 
