Recombinant DNA Advisory Committee - 09/9-10/93 
Dr. DeLeon stated that since the proposed vector, protocol, and target cells have been 
previously reviewed and approved by the RAC for other protocols, there are no major 
new issues for the RAC to discuss. Dr. DeLeon emphasized that the RAC should 
consider quality control standards and adopt guidelines for conducting similar types of 
trials at multiple sites. 
Review-Ms. Meyers (presented by Dr. Walters) 
Ms. Meyers' written comments raised several questions about the Informed Consent 
documents. Although they are generally well written, they should include information 
about the additional medical costs associated with participation in this study, long-term 
follow-up, other available experimental therapies, and a request for autopsy. 
Other Comments 
In his written comments, Dr. Smith raised the question of possible adverse effects in 
relation to the "asymptomatic gliosis" detected by MRI on one of the patients enrolled in 
Dr. Oldfield's protocol. This observation should be discussed in connection with the 
present protocol. 
Mr. Capron commented that the use of the term "you/your child" in the parent copy of 
the Informed Consent document is confusing. The way the document reads, it is unclear 
whether the parent or the child is undergoing treatment. Such documents would be 
more appropriately written separately in language that is understandable to each person 
signing the document, i.e., the parents, children 7-14 years of age, and children * 15 
years of age. 
Dr. Chase remarked that the investigators' response to comments by Ms. Meyers and Dr. 
Smith were inadequate. Dr. Parkman asked the investigators to elaborate on the 
inclusion criteria, i.e., the size of tumors and treatment of single versus multiple lesions. 
Investigator’ Response— Dr. Kun 
Responding to Dr. Geiduschek's question regarding the similarity of this proposal to 
other RAC-approved protocols, Dr. Kun explained that a given therapy may have 
different responses and toxicities depending upon the age of the patient. The present 
protocol targets childhood instead of adult tumors. This proposal differs from the 
previously approved pediatric brain tumor protocol submitted by Dr. Culver, et. al., in 
that the VPC will be stereotactically injected into the tumor mass rather than into an 
intracystic tumor cavity. Anatomical differences of the injection sites may produce 
different responses. 
In response to several Informed Consent document issues, Dr. Kun said that patients * 
18 years of age can legally give consent to participate in a protocol. "You/your child" 
would mean "you/yourself for patients over 18, and for patients below this age, it would 
mean "your child". The simpler assent form is to be signed by children under 18 with 
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