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 
4 of 
m 
pages. 
li 
r 
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 
y 
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. 
i 
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. 
Cvtovene ® administration: Seven days after surgery, infusions of Cytovene® will be started. 
^ 1 
During the administration of Cytovene® into one of your veins, you will initially be monitored in the 
Surgical Intensive Care Unit. You will undergo a repeat MRI scan before Cytovene® administration 
Cytovene® will be administered into a vein in a slow drip lasting one hour. The drug will be given jt 
two times a day for 14 days. 
Follow-up Care and Evaluation 
After you will finish the course of Cytovene® you will be discharged from the hospital. Two 
weeks after discharge, you will be required to return to the NIH as an outpatient for follow-up 
studies. You will undergo neurological and physical examinations and laboratory tests, as were 
f 
performed before your surgery. An MRI scan of the brain will also be obtained. Following the initial 
visit, you will be seen as an outpatient at 2 weeks intervals for 2 months and monthly for 10 months. 
The number of visits after the first year will depend on the status of your tumor. We expect that we 
will receive one sample of blood per year for the remainder of your life to monitor the safety of this || 
gene transfer methodology. 
PATIENT IDENTIFICATION 
- H 
CONTINUATION SHEET for either 
NIH-2514-1 (10-84) 
" 
[826] Recombinant DNA Research, Volume 15 
