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. A needle biopsy will be performed to confirm the 
diagnosis and to analyze as a pretreatment sample. Tissue will 
be stored as frozen sections for further immunohistochemical 
analysis and PCR. In addition, this nodule and other control 
(untreated) nodules will be imaged by CT immediately prior to the 
procedure, and its size quantitated. The skin overlying the 
tumor nodule will be sterilized and anesthetized using .01% 
lidocaine. For gene transfer, a 22-gauge needle will be used to 
inject the DNA liposome complex which will be prepared as 
follows: 10 minutes prior to delivery, 0.1 ml of plasmid DNA 
(.05-50 mg/ml) in lactated Ringer's solution is added to 0.1 ml 
of DMRIE/DOPE liposome solution (.15-15 /iM) . 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 0.8 ml of sterile lactated-Ringer ' s is added to the 
liposome DNA solution. The optimal composition of the 
DNA/ liposome complex has been established for each batch by 
titration of DNA concentration and liposome concentration 
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