additional four to six patients will be entered at that dose to 
ascertain the safety of this dose for wider application. 
Prior to the injection with the needle in place, gentle 
aspiration will be applied to the syringe to ensure that no 
material is injected intravenously. Immediately after the 
injection procedure, a blood sample will be obtained to check 
serum enzymes, chemistries, and blood counts, and to analyze for 
the presence of plasmid DNA in the peripheral blood by PCR. The 
patients will be observed in the Clinical Research Center for an 
additional 48 hours, and another blood collection performed as 
described in Section 9. If there are no complications, the 
patient will be discharged after 48 hours. Should any 
abnormalities appear, the patient would be kept for further 
observation. 
6.2 Confirmation of gene transfer and expression. 
Needle biopsy of the injected nodule will be performed after 
administration of local anesthesia prior to injection and 
subsequently just prior to each repeat injection. A portion of 
this tissue will be processed to obtain DNA for PCR analysis. 
The remaining tissue will be processed for pathologic analysis 
and immunohistochemical and/or immunof luorescent staining. If 
sufficient material can be obtained, RNA PCR analysis will also 
be performed. 
6.3 Analysis of immune response. 
Evidence of gene transfer can also be obtained indirectly by 
examination of the specific immune response to HLA-B7. The 
analysis will be performed as follows: two weeks prior to the 
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