MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
\|IH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor 3 2 t'.ent's Assent to Participate in A C'mical 
Research Study 
STUDY NUMBER CONTINUATION: page 5 of %ages. 
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. If you are at risk for injury by MRI 
scanning, you will undergo CT scanning instead. 
Risks of Surgery for Placement of Ommaya Reservoir: 
The surgical risks depend on the preoperative condition of the patient. Known risks 
associated with surgical placement of Ommaya reservoir include hemorrhage, local infection of 
the wound, meningitis, malfunction of the reservoir device which could require additional 
surgery, and death. The relative risks will be discussed with you in accordance with your 
condition and specific findings. 
Risks of Inserting a Spinal Fluid Drain: 
The risks for placement of a lumbar spinal fluid drain are similar as those for a routine 
spinal tap. There is risk of bleeding, infection, and injury to nerves to the legs. The risk of 
infection is higher than for a routine spinal tap, but remains small if the drain is removed after 7 
days as we plan to do. There is some risk of discomfort or temporary pain at the site of needle 
insertion in the lower back, as well as headaches which can accompany any spinal tap. 
Risks of the Vector/TK Gene Transfer: 
Even though the vector-producer cells cannot grow and are considered harmless in 
humans, it is possible that events could occur within the cells that would permit the vector to 
grow and/or make the cells cancerous. Gene transfer using similar vectors has been used in 
adults and children. Since these experiments started in 1989, none of the people who have 
received cells into which genes had been transferred by vectors has developed any problems 
related to the gene transfer method. We believe these vectors are safe and are not a threat to 
you, other people, or to society. 
This is the first experiment in humans that will involve the implantation of vector-producer 
cells into the spinal fluid. This method of treatment has 3 major potential problems. First, the 
vector may be passed into surrounding normal tissue in addition to tumor tissue. We have not 
found any evidence of problems in mice, rats, or monkeys due to the spread of vector to 
surrounding normal brain and spinal cord tissue or to other sites in the body. We believe that 
some of the surrounding blood vessel cells probably do have the vector, but the number is too 
small to result in significant adverse side effects. It is possible that bleeding and neurologic 
symptoms (headache, convulsions, stroke, paralysis) may develop with Cytovene. 
Second, the vector-producer cells might persist in your body and cause cancer or other 
diseases. We expect your immune system to reject (kill) the vector-producer cells in 1-2 weeks. 
Thus, they should not be able to survive and grow in your body. In addition, we expect the 
Cytovene therapy will kill all cells with the vector, including the vector-producer cells. Therefore, 
3 i- = \T OE\TF : CA7:ON 
CONTINUATION SHEET for either 
NIH-25 1 4-1 (10-84) 
G?0 9.1-329 
[618] 
NIH-25 1 4-2 (10-84) 
Recombinant DNA Research, Volume 18 
