protocol changes and will receive safety reports. Prior to initiating the study, the 
Principal Investigator will obtain approval from both the FDA and the NIH 
Recombinant DNA Advisory Committee (RAC). 
4.16 "IT AT" PREPARATION AND STORAGE: 
Autologous tumor surgically obtained from patients will be utilized to establish short 
term tumor cell cultures. The resultant cell culture will be transduced with the 7 -IFN 
retroviral vector construct. The transduced tumor cells will be subjected to standard 
microbiological biological testing as well as evaluated for mycoplasma. After lethal 
irradiation, the 7 -IFN-expressing tumor cell will be appropriately aliquoted and 
maintained at -135° C in sealed vials. They will then be thawed for re-injection into 
the same patient. The retroviral vector used in these studies is based upon Moloney 
murine leukemia virus, which has been engineered to replace its extraneous viral 
coding sequences with the human 7 -IFN cDNA. Unlike true viruses, the recombinant 
vector is incapable of replication since it lacks all of the viral structural genes. A 
detailed characterization of the vector gene construct will be presented to the RAC 
and the FDA for approval prior to initiation of the study. 
Recombinant DNA Research, Volume 17 
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