.iEDlCAL 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_Lof ?pages. 
and may Include the following: 1) x-rays of the brain, chest, and abdomen 2) blood 
tests 3) testing your blood for the antibodies to Human Immunodeficiency Virus (HIV), 
the virus that causes AIDS.’ If you are found to have these antibodies, you may not 
participate in this study. If you qualify for this study, we will place a catheter 
(small plastic tube) into a vein in your upper chest wall (Hickman catheter) or in your 
neck (jugular venous line). This catheter will be used to administer all compounds in 
this study and will remain in place for the duration of your therapy (placement of these 
catheters may be performed in the Surgical Intensive Care Unit). 
A section of one of your tumor will be surgically removed, and we will try to isolate the 
lymphocytes (a type of immune cell) from within the tumor and grow them in the laboratory i- 
large numbers. If this can be accomplished successfully, then these lymphocytes — known a 
tumor infiltrating lymphocytes (TIL) — will be returned to you by vein immediately before 
starting the IL-2 administration. You will receive the lymphocytes intravenously (by 
vein). The TIL cell infusion will take about one hour and the IL-2 infusions will each 
take about 15 minutes. This will be followed in two to 24 hours by an infusion by vein 
of interleukin-2 (IL-2), every eight hours for up to five days. To receive the therapy, 
you will be admitted to the hospital for about seven days. Every three weeks you will 
•eturn to the hospital for another similar treatment with TIL and IL-2, but using increasin 
numbers of TIL with each treatment, for a total of four treatments. 
RISK/ SIDE EFFECTS 
The risks to you of participating in this study may include the following. 
Placement of the Catheter 
It is possible that we might cause a small hole in the lung as we insert the catheter. 
This may require putting a tube in the chest for several days. The catheter may become 
infected. Appropriate treatment will be given if this occurs. 
Interleukin-2 
The administration of the interleukin-2 that you will receive can cause side effects that 
include weight gain due to retention of as much as 20 lbs of fluid over the course of a 
week. This weight gain results can cause your arms and legs to swell and can result in 
accumulation of fluid in the lungs. This can cause shortness of breath and require 
placement of a tube in your windpipe (trachea) to allow for mechanical breathing (breathing 
assisted by a machine). This would require that you be transferred to the Surgical 
Intensive Care 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 the use of appropriate 
medication. You also might develop nausea, diarrhea, a skin reaction with itching, nasal 
congestion, and abnormalities in kidney and liver function. You also may develop mental 
changes ranging from confusion and forgetfulness to disorientation. Other possible side 
effects Include fatigue and mouth dryness. It also Is possible your blood counts may 
drop and that you might require red blood cell and platelet transfusions. Heart problems 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
Recombinant DNA Research, Volume 14 
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