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. Serum for antibody to PA317 cells. 
c. PCR on peripheral blood mononuclear cell DNA for 
vector sequences. 
d. Western blot analysis of serum for antibody to 
retroviral antigens. 
e. 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 presence of the GlTkSvNa.29 vector by 
PCR. 
D. Criteria for Response 
1) Non responders: 
2 ) Minimal responders: 
2 ) Partial responders: 
3 ) Complete responder: 
E. Re-Treatment Criteria 
Patients who demonstrate one of the following responses to therapy 
will be considered for re-treatment with three 5 week cycles of VPC 
injection through the Ommaya reservoir. 
1) . Patients who achieve a minimal, partial or complete 
response . 
2) . Patients who achieve a complete response and then show 
new evidence of disease progression in the same location 
of the original resection. 
3) . Patients who have stable disease for at least 4 months 
following the initial surgery. 
4) . Patients who had no evaluable disease on the post- 
operative CT or MR scan, but later show evidence of 
progressive disease. 
F. Of f -Treatment Criteria 
Criteria for going off therapy: The major criterion for suspending 
enrollment of patients into the protocol would be evidence of 
Less than 25% decrease or increase in the 
bidirectional diameter of the tumor by CT 
scan and/or MR scan. 
25-49% decrease in tumor size defined by 
the greatest bidirectional diameter by MR 
or CT scan. 
>50% decrease in tumor size by CT scan 
and/or MR scan defined by the greatest 
bidirectional diameter by MR or CT scan. 
No remaining tumor on CT scan and/or MR 
at 3 months of 4 weeks duration. 
[ 66 ] 
Recombinant DNA Research, Volume 18 
