MEDICAL RECORD 
CONTINUATION SHEET for either: 
N!H 2514-1. Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
I STUDY NUMBER: 
CONTINUATION: page 3 nf ll pagpg 
once a week. 
If any tumor grows at these sites, we will allow it to grow until it 
reaches a size of about one-half inch. The site where the tumor was injected 
in the thigh will be surgically removed. The operation will probably be done 
under local anesthesia but may require general anesthesia. An incision 
several inches long will be necessary to do this and this can lead to 
bleeding, infection and possibly swelling in the leg. Lymphocytes will be 
grown from any tumor found. It is possible that we will not be able to grow 
lymphocytes from this tumor deposit. The best chance for growing lymphocytes 
in media already partly used by lymphocytes. We will make this media using 
lymphocytes taken from your vein blood by a procedure called apheresis. The 
lymphocytes are removed by a machine to which you are connected with two 
venous catheters (thin plastic tubes); the liquid part of the blood (plasma) 
and the red blood cells are returned to your veins. The procedure typically 
takes a few hours and rarely has any side effects. 
If by three weeks no tumor has grown at the site of the injection, we 
will make a small incision in the groin and remove several lymph nodes from 
this area. This can usually be done under local anesthesia. We will attempt 
to grow these lymphocytes in culture for use in your treatment although it is 
possible that they will not grow. 
If the lymphocytes from either the tumor site or from the draining lymph 
nodes do grow sufficiently, they will be transfused back into you along with 
IL-2, a protein normally made by the body's immune system. You will receive 
Recombinant DNA Research, Volume 15 
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