4. RISKS, SIDE EFFECTS AND DISCOMFORTS TO THE PARTICIPANTS 
PRIOR STUDIES. 
In previous published studies with X-rayed tumor cells, the side effects 
have been redness and swelling at the site of injection. No one has had 
a serious allergic reaction to the immunizations. 
A virus was used to incorporate the blueprint for IL-2 into the melanoma 
cells you will receive. The virus cannot grow on its own. A similar 
virus was used in a recent study at the National Cancer Institute. Only 
a few patients received the virus, but so far there have been no serious 
side effects. However, this is a very new technique and serious side 
effects may yet be seen. There is a remote possibility that the 
irradiated melanoma cells used for the immunization produce a virus not 
detected with our screening methods. Should a virus be reproduced there 
is a possibility that you may develop symptoms of a viral infection. 
Members of this virus family are known to cause lymphomas (a form of 
cancer) in rats and mice. The risk is much lower than might occur 
following chemotherapy and irradiation. Should you suffer a severe 
reaction to the immunizations, the treatments will be discontinued. 
You will be informed of the progress of the research study. During the 
time that you participate, you will be informed of any new findings 
which might affect your willingness to continue. 
If you are injured as a result of your participation in this research 
study, emergency care will be provided free of charge. Hospitalization, 
and out-patient care will be available to you by the Hospital and billed 
to you as part of your medical expenses. No money will be provided by 
the University of Illinois Hospital or as compensation for a research- 
related injury. 
5. POTENTIAL BENEFITS 
The use of genetically modified cells may be of benefit to patients in 
future protocols but this research will not be of immediate benefit to 
patients entering this trial. The major benefit will be to patients in 
the future who are participating in this study. 
6. ALTERNATIVE PROCEDURES OR TREATMENTS. RIGHT OF WITHDRAWAL. 
Participation in this study is totally optional. Should you decline to 
take-part, you will continue to receive standard treatments available to 
others with a disease similar to yours. The choice to enter or not to 
enter the study is yours. You are in a position to make a decision if 
you understand what the doctor has explained and what you have read 
about the research study and other possible forms of care. If you 
decide not to participate, the other choices are available to you 
without prejudice. If you begin the study, you will have a right to 
withdraw at any time. If you should withdraw, you will be offered other 
available care which suits your needs and medica'l conditions. 
Recombinant DNA Research, Volume 18 
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