3.2.2 Active autoimmune disease. 
3.2.3 Hepatitis (acute or chronic active). 
3.2.4 Active infection. 
3.2.5 The following therapies within the past three weeks: 
• radiation, 
• chemotherapy, 
• steroidal (glucocorticsteroids). 
3.2.6 Diabetes mellitus not controlled by medical treatment. 
3.2.7 Psychiatric illness that may make compliance to the clinical 
protocol unmanageable or may compromise the patient's ability to 
give informed consent. 
3.2.8 Immunoincomptetence as defined in eligibility criteria. 
4.0 Test Schedule - See Appendix 
5.0 Stratification Factors - None. 
6.0 Registration/Randomization Procedure 
6.1 Prior to discussing protocol entry with the patient, call the Randomization 
Center to insure that a place on the protocol is open to the patient. 
6.2 To register a patient, call (4-2753) or fax (4-0885) the Randomization 
Center between 8 a.m. and 5 p.m. central time Monday through Friday. 
6.3 A signed HHS 596 form must be on file in the Randomization center 
before an institution may register any patients. 
6.4 Patient eligibility and the existence of a signed consent form will be 
checked by Randomization Center personnel before a patient will be 
registered into this study. Dose level will be given. 
6.5 Treatment on this protocol must be given at the Mayo Clinic-Rochester on 
an impatient basis under the supervision of a medical oncologist. Actual 
intralesional injection of tumor will be carried out by Dr. J. William 
Charboneau or Dr. Carl Reading, Department of Diagnostic Radiology. 
6.6 Treatment must begin within 15 days of registration. 
6.7 Pre treatment tests must be completed within the guidelines specified on 
the test schedule. 
7.0 Protocol Treatment 
7.1 Patients will be admitted to the General Cancer Research Center (GCRC) 
at Saint Mary's Hospital prior to each intralesional injection. 
7.2 Identification and localization of a specific liver metastasis for injection 
using hepatic ultrasound meeting the criteria stated in section 3.0 will be 
carried out by Drs. Charboneau or Reading. 
7.3 The appropriate volume of DNA/lipid mixture prepared in Saint Mary's 
Pharmacy will be injected into the pre-selected hepatic metastasis on day 
1. The injection is done by the diagnostic radiologist using standard 
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