3.0 SAFETY INFORMATION 
3.1 Continued absence of replication competent infectious virus was determined 
from transfection-infection experiments. A neo-containing vector was 
transfected into packaging cells; colonies were selected with G418. The 
supernate were used to infect NIH 3T3 cells. Selection with G418 will be done 
after both 72 hrs and one month to ensure the survival of rare recombinants 
that do not have the neo gene but subsequently infect neo - positive cells. 
Supernate from the infected NIH 3T3 cells should not be infectious. These 
secondary supernate were used to infect naive NIH 3T3 cells. Lack of infectivity 
indicates absence of replication competent virus. To date experiments have 
been negative. These studies and the following safety studies will be performed 
by Genetic Therapy, Inc. 
3.2 Sterility will be assured by testing for aerobic and anaerobic bacteria, fungus, 
and mycoplasma. 
3.3 S + /L' assay including 3T3 amplification must be negative. 
3.4 PCR assay for the absence of 4070A envelope gene must be negative. 
3.5 Reverse transcriptase assay must be negative. 
4.0 PATIENT ELIGIBILITY 
4.1 Patients must have histologic proof of non-small cell lung cancer. Patients must 
be either unresectable, unable to receive primary external beam radiation 
therapy, or have failed primary external beam radiation therapy. Patients must 
have bronchial obstruction as their major problem requiring therapy. Patients 
will be excluded or removed from the study if at any point they require systemic 
chemotherapy for control of progressive metastatic disease. 
4.2 Patients must have an endobronchial tumor accessible by the bronchoscope. 
There must be some clinical evidence of bronchial obstruction. 
4.3 All patients must have a life expectancy of at least 1 2 weeks and must have a 
performance status of_<2 (Zubrod scale, Appendix B). 
4.4 All patients must sign an informed consent indicating that they are aware of the 
investigational nature of this study in keeping with the policies of the hospital. 
The only acceptable form is the one attached at the end of this protocol. 
4.5 A tumor biopsy must show either a K-ras mutation or a p53 mutation by single- 
strand conformation analysis 27 . Material obtained previously and embedded in 
paraffin may be analyzed. If a new biopsy is required, the patient will be 
entered into the protocol and informed consent obtained if protocol entry is the 
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