r 
2. There may be pain, itching or a rash at the injection sites. These complications will 
be treated with medications, should they occur. If these side-effects at the injection sites 
are severe and do not respond to medications it may be necessary to surgically remove the 
affected tissues at the injection sites. Surgical removal of this tissue may be associated 
with pain, bleeding, infection and scar formation. 
3. I may experience an allergic reaction to the injected materials. Allergic reactions 
may include symptoms such as fever, chills, rash, itching and low blood pressure. In some 
patients, these allergic reactions may be so severe as to be life-threatening. These allergic 
reactions are not expected to occur and they will be treated in the event that they develop. 
Because this is a new and untried treatment, it is possible that other risks not mentioned 
and not presently known could occur. 
4. The injections may induce immune responses against normal cells in the digestion 
system and cause gastritis or colitis. Immune responses directed against normal tissues are 
termed "autoimmune reactions". Other possible autoimmune reactions may include skin 
rashes and joint inflammation. These reactions will be treated with appropriate 
medications. 
5. The research methods employed in this study utilize a virus to infect and transfer 
the interleukin-2 gene into the cells. No serious side-effects have been observed in limited 
human studies with this procedure. There are, however, some theoretical risks associated 
with these methods While the virus utilized to transfer genes into my cells has been 
modified to prevent its ability to proliferate and infect other cells, it is theoretically 
possible for the virus to become infectious. However, this is not expected to occur. A 
blood test will be performed to determine whether an infectious virus has been generated. 
If an infectious virus is detected, I will be isolated in a hospital room or my home until the 
virus disappears from my blood. 
6. The genetically modified cells will also contain a gene that produces a protein that 
inactivates certain antibiotics. These antibiotics are not commonly used in the treatment of 
human infections. In addition, as many other more commonly used antibiotics are not 
inactivated by this substance, the procedure is not expected to affect the therapy of 
bacterial infections that may occur during the course of my illness. 
7. There may be some pain, bleeding, bruising or infection at the blood withdrawal 
sites in my arms. These potential complications are rarely severe. 
Benefits Of The Study 
There may be no direct benefit to me from this experimental therapy. It is possible that 
these treatments may enhance my body's immune response to my cancer. However, even 
if this occurs, this may have no beneficial effect on the course of my illness. However, 
from my participation in this study, the investigators may learn more about the role of the 
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Recombinant DNA Research, Volume 18 
