m. Biopsy of tumor, if possible with minimal 
morbidity. 
9.2 Treatment. 
Patients will be analyzed with routine blood and chemistry 
analysis. A chest x-ray will be performed each month for six 
months and every six months thereafter or more often if needed. 
During the gene transfer protocol, patients will be monitored 
closely in the Clinical Research Center. Vital signs will be 
measured every 15 minutes prior to, during, and after the 
injection for at least two hours or until the patient is stable. 
A pulse oximeter will be used for on-line measurement of oxygen 
saturation during injection as well. If the systolic blood 
pressure drops below 80 mm/Hg or the oxygen saturation drops 
below 90%, the injection will be terminated immediately. 
9.3 Post- treatment . 
Cutaneous lesions will be evaluated by physical examination, 
biopsy if feasible, and appropriate imaging scans prior to 
injection, monthly for 6 months and six-month intervals or as 
needed to evaluate response to treatment. Serum will be analyzed 
by PCR for the presence of plasmid, and antibody to HLA-B7 will 
be evaluated. PBL's will be isolated and analyzed for their 
ability to lyse HLA-B7 modified autologous EBV-trans formed lines. 
If ANA becomes positive or other signs of autoimmunity appear, 
evidence of more specific autoantibodies, e.g., anti-Rho, Smith, 
etc. , will be tested and rheumatology consultation will be 
sought . 
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