MEDICAL RECORD CONTINUATION SHEET for eithe 
DY NUMBER CONTINUATION:, page gages. 
to do'spvpral sorr >ewhat inconvenient, this spinal fluid drain will prevent the need 
trea°ment P * P d3y ° ° btam the Spinal fluid sam P les that we need to evaluate your 
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Cytovene administration: 
n..rin^^h« e Jli dayS + aft * er in ^ c i ion of vector-producer cells, Cytovene infusions will be started. 
^[^'n'Stration o« Cytovene into one of your veins, you will stay in a regular hospital 
room. 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 
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 
P® med before your surgery, including a spinal tap and obtaining a spinal fluid sample from 
the Ommaya reservoir. 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. 
RISKS 
Risks of MRI: 
MRI is a painless procedure that is very safe for most patients. During the MRI study you 
will lie flat in a long metal cylinder, which people who fear closed spaces sometimes find a little 
frightening. 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. 
A small proportion of people develop short-lived reactions during the gadolinium 
administration including nausea, headache, hot flashes, and heart palpitations. These symptoms 
usually resolve spontaneously within minutes. A smaller group of patients are actually allergic to 
the dye and may develop a rash, hives, respiratory difficulty, and in extreme cases pulmonary 
and cardiac arrest and death. You will be closely monitored and if an allergic reaction develops, 
you will be promptly treated with epinephrine and breathing assistance if necessary. Both 
therapies are immediately available in the room where the MRI scan will be performed. 
Patients at risk for injury from MRI are those with pacemakers, aneurysm clips (metal clips 
CONTINUATION SHEET for either 
NIH-25U-1 (10-8*1) 
i 911-329 NIH-25 1 4-2 ( 1 0-84) 
Recombinant DNA Research, Volume 18 
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