PROTOCOL THS 94-002 
REVISED 05/24/94 
PAGE 2 OF 6 
These patients are scheduled to have bronchoscopic exams as part of their 
evaluation either under local anesthesia or general anaesthesia. The 
surgeon performs an examination using a regular white light source to 
illuminate the tracheobronchial tree. If a tumor is found that is obstructing a 
portion of the tracheobronchial tree, that patient will be considered eligible 
for the study. It must also be possible to reduce the number of tumor cells 
to a small amount with removal through the bronchoscope or laser 
treatment. 
The tumor must have a specific gene mutation in it. It may be possible to 
find this mutation in specimens from previous biopsies. However, if these 
are not available new biopsies must be performed. If the new biopsy 
material does not show the mutation, the patient cannot participate in the 
study. The residual tumor will be injected once with an adenovirus 
containing a gene that possibly can correct an abnormality detected in the 
cancer cells. This treatment will be repeated monthly as long as there is 
evidence that the tumor is not growing. The cost of the routine 
bronchoscopy and biopsies which are part of the work up of patient's 
condition shall be his/her responsibility. The patient will receive cisplatin, a 
drug, along with the adenovirus. The patient will be treated for 3 days with 
a drug called cisplatin which is a chemotherapeutic agent. This will assist 
the adenovirus in killing the tumor cells. A maximum of 21 patients will be 
entered in the intratumor and the intrapleural groups, respectively. 
The investigators wish to follow the patient's medical condition for the rest 
of the patient's life. If the patient should move, the patient should notify 
Dr. Roth's office. 
PERMISSION FOR AUTOPSY: In case of death, the family of the patient 
will be asked for an autopsy because an accurate documentation of the 
precise cause of death may be important to all future patients. 
4. RISKS, SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: 
Two additional biopsies will be required in addition to the initial biopsy. A 
bronchoscopic biopsy samples a very tiny piece of the mucosa. Risks of 
biopsies include hemoptysis (coughing up blood) which is usually transient 
and self limited. Severe hemorrhage requiring emergency maneuvers 
including intubation and thoracotomy are exceedingly rare. Although 
extremely rare, any experimental procedure may result in unforeseen risks. 
Appropriate medical therapy will be made available for the treatment of such 
side effects. 
Rfecombinant DNA Research, Volume 19 
[605] 
