D. 
protocol, a formal list of changes will accompany the amended 
protocol and these will be submitted to the FDA, the site's 
IRB and other committees. 
Publications resulting from Trial. Any manuscript, abstract, 
or presentation will be available to all the study 
investigators involved in this protocol and the sponsoring 
company for review prior to submission. 
IV. Nature of Procedures or Therapeutic agents. (See schema in 
Appendix F) 
A. Surgical Procedures. For patients with unresectable tumor, 
VPC will be injected stereotaxically into multiple tumor sites 
(maximum of 5cc total volume VPC) . For patients with 
resectable lesions a craniotomy will be performed and optimal 
tumor removal will be attempted (day 1) . The lining of the 
cavity will then be infiltrated at multiple sites with the HS- 
tk VPC (day 1) to a maximum volume of 10 mL. VPC suspended 
at a concentration of 1-2X10 8 cell/ml will be innoculated 
slowly in 0.1 to 0.25 inocular at sites distributed as evenly 
around the tumor site as possible. A diagram of the sites of 
the inocula and volumes of cells delivered at each site will 
be kept as part of the permanent research records. An Ommaya 
reservoir, which provides an access port to the brain, will 
be placed into the tumor bed. 
B. Use of the Ommaya Reservoir. Seven days after the initial 
surgery, the Ommaya reservoir will have sealed into the 
patients brain and surrounding tissues. On day 8 the skin 
overlying the Ommaya will be cleansed with betadine. A needle 
will be inserted through the overlying skin into the reservoir 
with the patient awake. With the patient in the recumbent 
position the Ommaya reservoir will be gently irrigated with 
normal saline to clarify the contents of the tumor cavity. 
An attempt will be made to deliver no less than 5 or more than 
10 cc of VPC. The administration of VPC cells through the 
Ommaya will be followed by a flush of normal saline equal in 
volume to the volume of the Ommaya delivery system. GCV will 
be administered starting on the 15th post-operative day for 
14 days (days 15-28) . Repeat administration of producer cells 
will be done on day 49, followed by another cycle of GCV 
administration 14 days later (days 63-77) . Re-treatment will 
consist of VPC injection through the Ommaya reservoir on day 
1 of the cycle, GCV will commence on day 15 to continue for 
14 days (days 15-28) . No treatment will be given for 7 days 
(days 29-35) . Cycle 2 of 3 begins on day 36. A CT or MR scan 
will be obtained every 5 weeks during this part of the study. 
C. Volume and number of injected cells: Factors such as tumor 
size, location, and the preoperative neurological condition 
of the patient will determine the injectable volume. The 
final cell concentration will be adjusted to 1-2X10 8 cells/mL. 
D. Peri-operative medications: 
1. Antibiotics: All patients will receive a single dose of 
vancomicin or the equivalent just prior to the initial 
surgical procedure and prior to the injection of the Ommaya 
reservoir. 
2. Steroids : All patients will receive dexamethasone at 0.05 
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Recombinant DNA Research, Volume 18 
