13.5 Preparation and culturing of fibroblasts, retroviral gene transduction- 
Iirmunologic Monitoring and Cellular Therapy Laboratories assisted by Dr. Tahara 
and Zitovogel. 
13.6 Preparation of viral supernatants and safety testing- HGTAL/PCI assisted 
by Drs. Tahara and Zitovogel. 
14 . 0 RISKS AND BENEFITS 
Adverse effect will be recorded and available in the clinical protocol of 
systemic interleukin-12 which preced this gene therapy protocol. However, it is 
unlikely that severe and life threatening toxicities will be induced by the low 
levels of IL-12 elaborated locally from the injection sites. 
Individual patients may benefit by having their tumors shrink or 
disappear. Symptoms related to cancer may improve if shrinkage of tumor is 
achieved. The population of patients with cancer may benefit from this trial 
which may define the role of in vivo tumor vaccine using cells genetically 
modified to produce cytokines such as IL-12. 
If there are serious systemic effects of the IL-12 gene therapy, which we 
believe are unlikely to occur, the injection site can be surgically excised. As 
an additional safety factor, fibroblasts have been shown to stop producing 
transfected gene products in murine models after one to two weeks. 
15.0 COST AMD PAYMENTS 
Patients will be expected to provide insurance coverage for payments for 
all routine and subsecpjent care, and for any sickness or problems that may arise 
out of the nature of your disease. They will be charged as for routine 
treatments for all outpatient visits, hospitalization, routine blood samples and 
other tests performed to evaluate the course of tumor prior to and following 
this progreim of therapy. Gene transfection procedure and biopsies necessary for 
the experimental portion of this protocol will be supplied free of charge. This 
institution will bear the acute costs of non-negligent injuries arising out of 
the experiment. Cost will not be a factor in determining who will be treated. 
The cost of the experimental therapy will be born by the University of 
Pittsburgh. 
16.0 TREATMENT SCHEMA 
DM. 0 1 2 3 4 5 6 7 8/ 714/ /21/ 728/ /35 42 
INJECTION 
BIOPSY 
X 
X 
X 
X 
X 
BLOOD 
X 
X 
X 
X 
X 
X X 
CXR 
X 
X 
X 
X 
X 
X X 
PHYS EXAM 
[662] 
X X 
X 
X 
X 
XXX 
Recombinant DNA Research, Volume 19 
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