MEDICAL 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: 86-r-lp? 
CONTINUATION: page_L.of pages 
red blood cell and platelet transfusions. Heart problems can occur including irregular heal 
beat, low blood pressure, and .heart attack. Some patients have had perforation of- the colot 
with inflammation and infection within the abdomen requiring an operation. It ia very unlit 
though possible, that this treatment could cause your death. In previous studies these aid/ 
effects have been transient and have turned to normal after discontinuing the administ ratio! 
of IL”*2. Other unknown side effects may occur. 
I 
For the administration of interleukin-2 an Intravenous catheter will be placed through • '- 
a vein either on the upper chest wall or in the neck that will be threaded into a 
central vein in the body. Other intravenous needles may be needed on the upper cstremitiesi 
This care often will be performed in the Surgical Intensive Care Unit. 
If we can obtain some of your tumor, an attempt will be made to isolate the lymphocytes . '.I 
(a type of immune cell) from within the tumor and grow them to large numbers. If this can 
be accomplished successfully then the cells will be returned to you into a vein immediately 
prior to starting the IL-2 administration; The administration of these cells may cause 
side effects including fever, chills and some shortness of breath. These are expected, 
based on our past experience, to- last for only a few hours. Because these lymphocytes are 
grown from your tumor it is possible that the lymphocytes that are reinfused into you. may 
contain tumor cells. We will carefully examine the cells you are given to decrease the 
chance that this may occur. ' ■ 
You will be required to return to the NIH for follow-up studies four weeks and eight weeks ;ij 
after treatment. If you respond to the treatment it is possible that the treatment will I 
be repeated. 
If your disease recurs after treatment in this protocol then you will be eligible to be- 
considered for -other protocols at the National Cancer Institute and you will receive treatmj 
as indicated by your disease or referred elsewhere for such treatment. As this is a new 
therapy side effects that may cause your condition to deteriorate may be encountered. You’ ; 
will be watched closely for any side effects. • * i 
You understand that you are free to withdraw your consent ,to participate in this study at 
the National Cancer Institute and seek care from any physician at any time. 
Pi 
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Recombinant DNA Research, Volume 14 
