b. Renal and hepatic blood chemistries (uric acid, calcium, phosphorus, magnesium, 
SGOT, SGPT, Alkaline Phosphatase, LDH, total bilirubin, BUN, creatinine, 
albumin, total protein, electrolytes, glucose) 
c. Physical examination with a detailed neurologic exam. 
d. p-HCG serum pregnancy test will be repeated monthly for women with child 
bearing potential while on therapy. 
e. Radiological evaluation: Patients will have a CT scan or MRI of the brain (if 
needed) with contrast enhancement if appropriate. 
f. Freeze serum sample and peripheral blood mononuclear cells. 
2. Yearly follow-up laboratory evaluation . Patients will be requested to be followed once a year 
for the rest of their life for retroviral gene transfer safety monitoring. 
a. CBC with Differential count 
b. Repeat Immunologic evaluation. 
c. Serum for antibody to P A3 17 cells. 
d. PCR on peripheral blood mononuclear cell DNA for vector sequences 
e. Western blot analysis of serum for antibody to retroviral antigens 
f. If at any time a new malignancy develops, we shall attempt to obtain involved 
tissue for analysis for the vector DNA. 
3. 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 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. 
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) and/or bone marrow, 
will be evaluated for the presence of the GlTkSvNa.29 vector by PCR. 
D. Criteria for Response 
1) Non responders : No observable decrease in the size or progression of the tumor by 
CT scan and/or MRI scan. 
2) Minimal responders : 25-49% decrease in tumor volume by CT scan and/or MRI 
compared to the size on post-op day 7 of 4 weeks duration. 
2) Partial responders : _>50% decrease in tumor volume by CT scan and/or MRI 
compared to the size on post-op day 7 of 4 weeks duration. 
3) Complete responder : No remaining tumor on CT scan and/or MRI at 3 months of 4 
weeks duration. 
E. Off-Treatment Criteria 
Criteria for going off of therapy : The major criterion for suspending enrollment of patients 
into the protocol would be evidence of significant toxicity that is directly related to the 
application of our experimental therapy. Such toxicity may include the following: 
a. Irreversible diffuse cerebral dysfunction (motor, sensory, cognitive). 
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