MEDICAL RECORD 
CONTINUATION SHEET for either: 
VH 2514-1, Consent to Participate in A Clinical Research Study 
V;- 2514-2, Miner 3 3tient's Assent to Rarticcate in A Clinical Researcn Study 
STUDY NUMBER CONTINUATION: page 
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es. 
through that vein before obtaining a second set of scans. Each scan takes about 60 to 90 
minutes. MRI scans will be repeated periodically after injection of the vector-producer cells to 
monitor the effects of this therapy on tumor growth. 
TREATMENT PHASE 
You will undergo 4 procedures in the following order: (1) surgery for placement of a 
reservoir device (Ommaya reservoir) with a catheter inserted into the spinal fluid cavity 
(ventricle) in the brain, (2) injection of vector-producer cells into the reservoir device, (3) 
placement of a spinal fluid catheter in the lower back for sampling spinal fluid for 7 days after cell 
injection, and (4) intravenous administration of the drug Cytovene. The treatment phase is 
expected to require a 3-4 week hospitalization. 
If you show improvement after this treatment phase, but later show evidence of disease 
progression, we may consider repeating the cell injections and Cytovene administration during 
another hospitalization 
Placement of Ommaya Reservoir: 
Surgery will be performed under general anesthesia. A small area of the right frontal 
scalp will need to be shaved. A curved skin incision about 2 inches in length will be made in the 
scalp and a drill hole will be made in the skull. Through this hole a thin plastic tube will be 
passed into the fluid filled cavity, or ventricle, in the brain. This tube will then be connected to a 
plastic reservoir (Ommaya reservoir), roughly the size of a quarter, and the skin closed over this 
device so that it will lie entirely under the skin when the incision heals. Medications and vector 
producing cells can be injected into the reservoir with a hypodermic needle through the skin, 
thus providing access into the spinal fluid system. Spinal fluid samples can also be withdrawn 
through the reservoir using a hypodermic needle. 
Injection of Vector-Producer Cells: 
The vector-producer cells will be injected through the Ommaya reservoir. This will be 
done at the bedside in the hospital room. The skin over the reservoir will be cleaned sterilely 
and the cells, suspended in a small amount of liquid, injected through the skin and into the 
reservoir with a hypodermic needle and syringe. This will probably cause no more discomfort 
than drawing a blood sample through a vein in the arm. 
Placement of Lumbar Spinal Fluid Drain: 
In order to obtain frequent spinal fluid samples immediately after cell injections, a lumbar 
spinal fluid drain will be placed. This procedure is similar to a routine spinal tap except that a 
very thin, soft plastic tube is inserted through the spinal tap needle and is left in place connected 
to a drainage bag. This procedure is done at the bedside in the hospital room using local 
anesthesia. This drain will remain in place for 5-7 days and during this time you will need to 
= at:e\t DE\7:FiCA7 C.N 
CONTINUATION SHEET for either 
NIH-2514-1 (10-84) 
GPO 9 * 1 -329 
[616] 
NIH-2514-2 (10-84) 
Recombinant DNA Research, Volume 18 
