existing or suspected malignant and non-malignant disease. 
6.5 The location and size of the endobronchial lesion must be recorded prior to 
treatment. A photograph of the area will be taken at a fixed distance from the 
lesion. The area will be measured in 2 dimensions (product of longest and 
perpendicular dimensions). 
EVALUATION DURING STUDY 
7.1 Patients will have a CBC, platelet count, PT, PTT, SMA-12, electrolytes, and a 
chest x-ray prior to each course of therapy. Serum will be collected pre- and 
post-treatment for analysis of antibodies to retroviral proteins. 
7.2 History and physical with performance status and weight should be recorded 
before each course. 
7.3 The tumor will be photographed bronchoscopically at the beginning of each 
course. Tumor measurements are to be recorded before each course. 
7.4 All relevant information regarding drug dosage, tumor response, laboratory 
examinations, and treatment-related toxicities must be recorded before each 
treatment is given. 
7.5 Parameters to be Measured In Vitro 
7.5.1 Bronchoscopic tumor and normal bronchial epithelial biopsies will be 
obtained prior to the beginning of each course. Tissue will be fixed 
immediately in 4% paraformaldehyde and 0.5% gluteraldehyde at 4°C. 
This will permit extraction of DNA and RNA and permit in situ 
hybridization. 
7.5.2 Biopsies will be analyzed for incorporation of the transduced gene into 
the host genomic DNA and expression of the transduced gene at the 
RNA level by standard hybridization techniques following polymerase 
chain reaction and by in situ hybridization. 
7.5.3 All patients will be evaluable for response and toxicity following one 
course of therapy 
CRITERIA FOR RESPONSE AND TOXICITY 
8.1 The tumor bed will be photographed prior to each course of therapy. 
8.2 The longest diameter and its perpendicular will be measured. Size will be 
reported as the product of the diameters. 
Recombinant DNA Research, Volume 16 
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