protocol including the initial one to demonstrate unequivocally by histologic 
examination of a frozen section that the metastasis selected for injection of the 
DNA/lipid complex is, in fact, metastatic cancer. Biopsy samples are never 
tobe placed in fixative. 
16.2 For biopsies in which a core of tumor has been obtained, the sample will be 
subdivided and at least half frozen in liquid nitrogen. The remainder may be 
subjected to tissue disruption in an attempt to' obtain and expand T-cells 
present in the tissue. 
17.0 Records and Data Collection Procedures 
17.1 University of Chicago patient records. 
17.1.1 The University of Chicago medical records will be utilized for patients. 
Data will be entered into a data management file within 3 weeks after 
each evaluation of the patient. After the patient goes off treatment, 
follow-up information will be collected and entered into the data 
management file every 3 months. 
17.1.2 Pathologic diagnosis made by frozen section is reported in a 
conventional way with a record being placed in the patient's 
permanent medical record and data management file. 
17.1.3 Data from the central laboratory will be entered into the data 
management file. Summary reports of samples received will be 
sent to the principal investigator monthly. 
17.2 Vical records. 
Case report forms, regulatory documents and source documents 
will collected and reviewed in accordance with FDA Good Clinical Practices. 
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