iEDICAL 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 JL_ of IL pages. 
Unit. Less serious shortness of breath is common, and you may require oxygen 
delivered by a face mask during some portion of this treatment. Other side 
effects include fever and chills, which generally can be eliminated by 
appropriate medication. You also might develop nausea, diarrhea, a skin 
reaction with itching, nasal congestion, and abnormalities in kidney and liver 
function. Mental changes ranging from confusion and forgetfulness to 
disorientation have occasionally been observed. Other possible side effects 
include fatigue and mouth dryness. Your blood counts may drop to the point 
where you need red blood cell or platelet transfusions. Heart problems can 
occur, including irregular heart beat, low blood pressure, and heart attack. 
Some patients have developed a hole in their colon, resulting in abdominal 
inflammation and infection that required correction by surgery. In 
previous studies many of these side effects such as t he weight gain, nausea, 
diarrhea and liver and kidney dysfunction disappeared or were alleviated after 
stopping the IL-2 administratio n. Other unknown side effects may occur. 
It is' very unlikely, though possible/ that this procedure could kill you. 
Immune lymphocytes 
The administration of the lymphocytes may cause fever, chills, and 
shortness of breath. Based on our previous experience, these side effects are 
expected and should only last a few hours. Because these lymphocytes are 
grown from your tumor, it is possible that the lymphocytes returned to you may 
contain tumor cells. This may make your condition worse. We will carefully 
examine the lymphocytes that you are to be given to decrease the chance of 
Recombinant DNA Research, Volume 15 
[131] 
WH-2SH-1 <10-541 
