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 S> oi pages. 
5 
Cytovene® administration: Five days after open surgery, Cytovene® infusions will be started. 
During the administration of Cytovene® into one of your veins, you will initially be monitored in the 
II 
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 
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 
performed before your surgery. An MRI scan of the brain will also be obtained. Following the initial j 
visit, you will be seen as an outpatient at 2 weeks intervals for 2 months and monthly for 1 0 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. 
Risks 
Risks of MRI 
Patients at risk for injury from MRI are those with pacemakers, aneurysm clips (metal clips on 
the wall of a large artery), or shrapnel fragments. Welders and metal workers are also at risk for 
injury because of possible metallic foreign bodies in the eye. The study is done with you lying flat in 
a long metal cylinder. You will feel no pain. This may be frightening if you fear closed spaces. 
Patients can be observed at all times by the operators and can be assisted if necessary. You will be 
moved out of the machine if requested. The thumping sound you will hear is the radio waves 
forming the images. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either 
[ 842 ] 
NIH-25 1 4-1 (10-84) 
Recombinant DNA Research, Volume 15 
