11.0 Evaluation of Results 
11.1 Criteria for Response 
In this phase I study, the protocol will be considered 
successful if recombinant gene expression is achieved and an 
appropriate dosage established for effective gene transfer 
without toxicity. Confirmation of recombinant gene expression is 
described below. Additional evidence of successful gene transfer 
may also be obtained from immunologic analysis. A new CTL or 
antibody response to HLA-B7 will indicate successful gene 
expression and is described in Section 11.3. The ability to 
generate anti-tumor CTL will also be evaluated. Evidence for 
tumor regression will also be obtained. Complete tumor response 
is defined as the disappearance of all clinical evidence of 
disease for at least four weeks. Partial tumor response is 
defined as 50% or greater decrease of the sum of the products of 
perpendicular diameters of lesions lasting at least four weeks 
with no increase in existing lesions or appearance of new 
lesions. The response will also be considered positive for gene 
transfer if cytolytic T cell activity for HLA-B7 is obtained 
after this injection. Any patient having less than a partial 
response is considered to be non-responsive to treatment. Tumor 
dimensions will be assessed by imaging as detailed in Section 9. 
11.2 Confirmation of Recombinant Gene Expression 
Several independent techniques will be used to evaluate the 
presence and expression of the recombinant gene in vivo. We have 
used several monoclonal antibodies to HLA-B7 to detect the 
recombinant gene product in vivo by immunohistochemistry . 
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