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 physicians, 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 ARB for approval. 
4. An attempt will be made to perform a complete autopsy on any patient who dies. In 
addition to standard pathological examinations tissues will be taken for PCR 
analysis for the presence of persistent recombinant adenovirus (ADV/RSV-tk) 
DNA. 
C. Criteria for Response 
1 . Toxicity - Toxicity will be graded by the Common Toxicity Criteria published by the 
CTEP of the NCI (Appendix D). Signs and symptoms of neurological toxicity will 
be closely evaluated. 
2. Tumor response - 
Assessed by MRI 1 and 2 months post-op and defined as: 
a. Complete - No tumor on MRI. 
b. 99% to 75% decrease in the product of the maximal perpendicular cross- 
sectional diameters when compared with the pre-surgical baseline study. 
c. 74% to 50% decrease in the product of the maximal perpendicular cross- 
sectional diameters when compared with the pre-surgical baseline study. 
d. 49% to 25% decrease in the product of the maximal perpendicular cross- 
sectional diameters when compared with the pre-surgical baseline study. 
e. 24% to 0% decrease in the product of the maximal perpendicular cross- 
sectional diameters when compared with the pre-surgical baseline study. 
c. An increase in the product of the maximal perpendicular cross-sectional 
diameters when compared with the pre-surgical baseline study. 
D. Treatment Cessation Criteria 
1 . Permanent Grade 3 toxicity or recurrent Grade 4 toxicity as specified in the 
Common Toxicity Criteria published by the CTEP of the NCI. It should be noted 
that the assessment of neurological toxicity (as it appears in the Toxicity Criteria) 
relates to the relative changes from the pre-treatment neurological status. 
2. Other anticipated toxic phenomena that are not related directly to viral transduction 
of the brain tumor (such as toxicity secondary to GCV administration), or 
neurological complications which can be explained by the presence of the mass 
lesion and are compatible with the natural history of malignant brain tumors, will 
Recombinant DNA Research, Volume 20 
