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3. Description of research protocol : J have made the decision to undergo treatment with 
immune lymphocytes. It is not known whether treatment with immune lymphocytes obtained 
from tumors (TIL) have different properties than immune lymphocytes obtained directly from 
blood (PBL). 
To answer this question, I have been told that TIL and PBL will be genetically marked. This 
genetic marking is performed by mixing TIL and PBL with a specially engineered mouse virus 
which cannot cause an infection in the body. I have been told that this virus marks cells with 
a bacterial gene that makes it possible to find these cells after administration to jne. Two 
different mouse virus markers will be used - LNL6 and GINa - so that TIL and PBL can be 
compared. 
During treatment, biopsies of tumor and adjacent skin, fat, muscles and blood draws (lOcc, 1/24 
cup) may be requested of me one or more times. I may refuse these purely investigational 
procedures at any time without prejudice. 
4. RISKS, SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: 
I hav e been told that extensive study of this virus marking procedure has been undertaken in mice 
and monkeys. This virus and another like it are currently being studied at other institutions. I 
h ave bee n informed that no adverse effects have been observed in all of these studies because the 
virus is modified so that it cannot cause an infection in the cells of the body. It only marks a 
small number of cells. Risks, however, which may not yet have been observed, are possible. 
I know that these are "theoretical risks" since they have not yet been observed. It is possible that 
the virus could change the cells which are marked so as to grow in an abnormal pattern, and 
even cause cancer or leukemia. This risk is much lower than damage to the cells by 
chemotherapy and irradiation. The marker might also produce a protein which might inactivate 
certain antibiotics but alternative antibiotics are available so that this does not constitute a risk 
or threat for patients during therapy. 
I know tha t this clinical research may involve unforeseeable problems during treatment. To help 
prevent injury to unborn children, upon recommendation by the physician, I will practice 
adequate methods of birth control throughout the period of your my in this clinical research 
study. 
3. POTENTIAL BENEFITS: I underst and that the use of the marked cells to identify the fate 
of TIL and PBL after administration may be of benefit to patients on future protocols, but this 
research will not be of immediate benefit to me or others currently entering this trial. I clearly 
under stand that there is no direct benefit to me from stud y participa tion of genetic marki ng of 
my c ells, and there is the possi bili ty that my conditio n may become wors e. The major benefit 
is to patients in the future. 
HSPC #91-10-442 
Date of expiration 
Recombinant DNA Research, Volume 15 
[561] 
