6.0 Nature of Procedures or Therapeutic Agents 
6.1 Study Design. 
Patients will be admitted to the Clinical Research Center at 
The University of Michigan Medical Center after the relevant 
eligibility criteria have been met. The pre-treatment evaluation 
will be performed as described in Section 9. Patients undergoing 
the direct gene transfer protocol will have serum samples removed 
for analysis as described in Section 9. The tumor nodule to be 
injected will be identified and its borders measured prior to 
injection. In addition, this nodule and other control 
(untreated) nodules will be imaged by CT immediately prior to the 
procedure, and its size guantitated. The skin overlying the 
tumor nodule will be sterilized and anesthetized using .01% 
lidocaine. Immediately prior to injection with the DNA liposome 
complex, a needle biopsy of the nodule will be performed. Tissue 
will be stored as frozen sections for further immunohistochemical 
analysis and PCR. For gene transfer, a 22-26 gauge needle will 
be used to inject the DNA/liposome complex which will be prepared 
as follows: 10 minutes prior to delivery, 1 -10 /zg of plasmid 
DNA (20 /Ltg/ml) is diluted to 200 /il of lactated-Ringer's solution 
at room temperature and added to 5-10 /xl (10-20 nM) of DC-Chol 
liposome solution (2 mM) . Each component will be stored 
separately in sterile vials and certified as acceptable by the 
FDA. The solution is left at room temperature for 5-10 minutes 
and 0.5 of sterile lactated-Ringer's is added to the liposome DNA 
solution. The optimal composition of the DNA/liposome complex 
will be established for each batch by titration of DNA 
Recombinant DNA Research, Volume 15 
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