biopsies, new biopsies must be performed. The residual tumor will be injected 
daily for 5 consecutive days with a retrovirus containing a gene that may 
overcome the mutation detected in the cancer cells. This treatment will be 
repeated monthly as long as there is evidence that the tumor is not growing. 
4. RISKS, SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: 
A few additional biopsies will be required. 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. 
Extremely rarely, experimental procedures result in unforeseen harm. Appropriate 
medical therapy will be made available for the treatment of such consequences. 
4a. This clinical procedure may involve unforeseeable risks to the participant 
(or to the embryo or fetus, if the participant is or may become pregnant 
during treatment). To help prevent injury to unborn children, upon 
recommendation by the attending physician, the participants should 
practice adequate methods of birth control throughout the period of their 
involvement in this clinical research study. 
4b. Possibility of Causing a New Cancer. The possibility of causing cancer in 
normal cells exists although this risk is thought to be very low. Tests of 
viral supernate will be conducted to assure that possible disease causing 
virus is not present in the material to be injected. 
Risk from murine retrovirus. The retrovirus derived from the Moloney 
murine leukemia virus is modified so that it no longer contains intact viral 
genes. Thus it cannot produce an intact infectious virus. Therefore, the risk 
of getting a virus infection is extremely low. 
4c. A small amount of protamine is added to the retroviral mixture. Protamine 
is normally used to help blood clot. In this case it is used to help the virus 
enter the cancer cell. In the clone used it will not affect blood clotting. 
Infrequent allergic reactions and low blood pressure have occurred as side- 
effects when this drug is given. These are very unlikely to occur with the 
small dose given. 
5. POTENTIAL BENEFITS: There is potential therapeutic benefit from this procedure. 
It is possible that injection of the retrovirus will slow the growth of the tumor 
and prevent further blockage of the lung. This study will also form the basis for 
future studies which may be able to apply this technology to the treatment of 
earlier cancer. 
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Recombinant DNA Research, Volume 19 
