Recombinant DNA Advisory Committee - 03/1-2/93 
therapy, and 4 patients have completed treatment. No instances of toxicity have been 
observed in response to either VPC administration of GCV therapy. Dr. Culver noted 
that initial concerns about the possibility of thrombocytopenia and neutropenia in 
patients recovering from chemotherapy have not been observed. Efficacy data is 
unavailable at this time. 
Dr. Hirano inquired whether the VPC used in Dr. Oldfield's protocol are ever 
cryopreserved prior to administration to the patient. Dr. Culver responded that the VPC 
are cryopreserved and thawed immediately before they are to be administered to the 
patient. A minimal amount of time is allowed to count the cells and examine them for 
microscopic contamination. Animal studies demonstrate that cryopreserved cells are as 
effective as cultured cells in eliciting an anti-tumoral response. 
With regard to the issue of financial responsibility, GTI is sponsoring this protocol; 
therefore, patients will not be responsible for any costs associated with the research 
aspects of this protocol. If surgery is already indicated, as it most likely will, then the 
costs associated with the surgical procedures will be billed to third party payers. There 
are differences between the two institutions regarding compensation for research related 
injury. The Iowa Methodist Medical Center will provide care and compensation for any 
acute injury related to the gene therapy procedure; there is no mechanism for long-term 
care. Dr. Culver introduced Dr. Van Gilder to explain the compensation policy of the 
University of Iowa and to explain the use and history of the Ommaya reservoir. 
Presentation-Dr. Van Gilder 
Dr. Van Gilder stated that the University of Iowa would cover all costs associated with 
the research aspects of the protocol, and third party carriers will be billed for costs 
associated with routine surgical procedures. 
Dr. Van Gilder explained that an Ommaya reservoir is a small tubing, approximately 2 
millimeters in external diameter, that is placed into the center of the surgical resection. 
This tubing leads to a cap which is implanted directly under the skin of the skull, 
allowing for the direct injection of the cells through the skin and into the reservoir. 
Dr. Miller asked if virus particles can pass through this reservoir? Dr. Culver answered 
that experiments have been performed demonstrating that high concentrations of virus 
particles can be passed through the reservoir with no observed decrease in viability. In 
addition, VPC have been passed through the reservoir and shown to exhibit the same 
anti-tumor effect as control cells. Dr. Van Gilder explained that Ommaya reservoirs 
have been used as standard treatment for the administration of chemotherapeutic agents 
into the cerebral spinal fluid and ventricular system of cancer patients for many years. 
Dr. Leventhal asked for a clearer definition of the endpoints for the proposed study. 
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