PROTOCOL ABSTRACT 
I 
I 
Pr otocol: (Give number and abbreviated title) 
“Clinical Protocol for Modification of Oncogene and Tumor Suppressor Gene Expression 
Non- Small Cell Lung Cancer (NSCLC)" 
id 
Study Chairman: 
Jack A. Roth, M.D. 
Pa tient Eligibility: ^ 
Patients must have histologic proof of non-small cell lung cancer. Patients must be either j 
unresectable, unable to receive primary external beam radiation therapy, or have failed | 
primary external beam radiation therapy. i 
Patients must have an endobronchial tumor accessible by the bronchoscope. There must i 
be some clinical evidence of bronchial obstruction. I 
I 
All patients must have a life expectancy of at least 12 weeks and must have a 
performance status of ^2 (Zubrod scale. Appendix B). 1 
i 
All patients must sign an informed consent indicating that they are aware of the j 
investigational nature of this study in keeping with the policies of the hospital. The only , 
■oospteblf farm is the ^ne pf IhiH | 
A tumor biopsy must show either a K-ras mutation or a p53 mutation by single-strand | 
conformation analysis. | 
' 1 
Tr eatment Plan: (Include dose adjustment) ! 
Patients will undergo bronchoscopy to assess the degree of obstruction. As much gross ' 
tumor as possible will be resected endoscopically. Patients may also have had ; 
brachytherapy as a tumor reduction modality. | 
i 
Patients will undergo bronchoscopy under topical or general anesthesia. A Stifcor*"" 
transbronchial aspiration needle (21 g) will be passed through the biopsy channel of the ' 
bronchoscope. The residual tumor site will be injected with 10^ CPU of the appropriate , 
retroviral supernatant. The volume will be no greater than 10 ml. Injections will be 
circumferential and will be intratumor and submucosal. The AS-K-ras supernatant will be! 
used for K-ras mutations and the p53 supernatant will be used for p53 mutations. The f 
injections will be repeated daily for five consecutive days. The treatment will be repeated 
monthly. 
Recombinant DNA Research, Volume 19 
