• Anti-adenovirus antibodies. 
• Anti-p53 antibodies. 
7.8.2 Phlebotomy requirements: 
10 cc total of venous blood, concomitantly with the samples for the Study Serum 
Bank (Section 7.9). 
7.8.3 Timing of samples: 
Pre-infusion, Days 7, 14, 21, 28, and as part of the Follow-Up Evaluations during 
the first year (Section 7.6). 
7.8.4 Methodology: See Appendix G. 
7.9 Study Serum Bank 
7.9.1 Purpose: 
To preserve serum at specific time points for any further evaluations not listed in the 
study protocol. 
7.9.2 Phlebotomy requirements: 
10 cc total of venous blood, concomitantly with the samples for the immune 
response assays (Section 7.8). 
7.9.3 Timing of samples: 
Pre-infusion, Days 7, 14, 21, 28, and as part of the Follow-Up Evaluations during 
the first year (Section 7.6). 
7.10 Biological Efficacy Studies 
One of the main objectives of this study is to assess the biological efficacy of ACN53, 
including the efficiency and stability of p53 gene transfer. The molecular and cellular 
effects of ACN53 treatment upon normal and malignant tissue will be assayed. 
7.10.1 Source of tissue: 
Normal and malignant tissue from the ACN53-treated liver will be obtained 
during exploratory laparotomy (Section 7.4) or fine needle aspiration (Section 
7.5). These materials will then be submitted to the Study Tissue Bank. 
7.10.2 Biological effects to be assayed or ex amin ed (not all will be performed on material 
obtained by FNA): 
Distribution of ACN53 infection: 
Cell types. 
Anatomic and microanatomic location. 
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