- 
I 
EDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 
CONTINUATION: 
page_§_of JzL- pages. 
lay media. We will make every effort to protect the confidentiality of you 
and your family. However, because of this media interest there is a greater 
risk than usual that information concerning you and your treatment will appear 
publicly without your consent. A qualified representative of the manufacturer 
of IL-2 may have access to the patient and study reccords on this pro tocol . 
The injection of live tumor : cells back into you is unusual and highly 
experimental. Although any tumor appearing in the thigh can likely be 
controlled by surgical removal (or possibly by adding radiation therapy) these 
measures could fail resulting in progressive tumor in the thigh. It is also 
possible that this tumor may spread from this site and produce IL-2 at other 
sites and that we may not be able to control this. We do emphasize, however, 
that the amount of tumor that we are injecting into you is less than l/50th of 
the total amount of tumor we estimate is already in your body. It is however 
possible that you may suffer injury or disability such as pain, bleeding or 
infection from the tumor injected into the skin of the thigh. 
Possible Benefits For Participants 
We cannot predict if this new procedure will be of benefit to you. In 
past lymphocyte transfer studies, some tumor shrinkage was observed in some 
individuals but not in others. Even those tumors that exhibit shrinkage may 
show regrowth of the tumor after a short period of time (months). At this 
stage in your illness, tumor shrinkage may be associated with prolongation of 
life. 
Alternative Treatments 
There are no known curative treatments for patients with your disease. 
[134] Recombinant DNA Research, Volume 15 
N1H-2SH-1 (10-54) 
