It is understood that the performance of an individual study or test as 
specified in this protocol is subject to factors such as patient compliance, 
scheduling difficulties, equipment malfunction, or the clinical judgment of the 
principal investigator or patient care physician, and that a test therefore may not be 
done in an individual instance with no violation of the protocol. However, any 
systematic modification of the original protocol in this regard, whether related to 
patient safety or not, will be submitted to the IRB for approval. 
3. Tumor specimen processing and evaluation: Previously injected tumors removed 
during open surgery will be subjected to routine histopathological evaluation, staining 
for the presence of murine cells and DNA analysis for NeoR and Env (envelope) 
sequences. The relative proportion of NeoR to Env will provide a semiquantitative 
measure of the degree of tumor transduction. 
4. Autopsy : An attempt will be made to perform a complete autopsy on any patient who 
dies during the study. Whenever possible, tissues from the brain, tumor(s), bone 
marrow, will be evaluated for the presence of the GITKSVNa vector by PCR. Whenever 
the autopsy is performed outside the NIH, an attempt will be made to obtain the 
pathological slides of the CNS for review at the NIH. A tentative agreement to autopsy 
is included as part of the consent form. 
C. Criteria for Response 
1 ) Non responders: No observable decrease in the size or progression of the 
tumor by MRI scan. 
2) Partial responders: >50% decrease in tumor volume by MRI at any time 
point . 
3) Complete responder: 
a. No remaining tumor on MRI at 3 months for the surgically accessible groups 
b. No remaining tumor on MRI at 4 weeks for the surgically inaccessible groups. 
c 
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