It is hoped that your tumor might shrink in response to this treatment although 
this can not be determined precisely since experience with IL-4 and IL-2 
administration has not been obtained in patients. You should know that there is 
no benefit to you from having the gene inserted into your lymphocytes but 
important information may be derived that will help others. 
Risks and Benefits . 
The administrtion of the interleukin- 2 and interleukin- 4 could cause side 
effects that include weight gain, which can reach as much as 20 pounds of fluid 
over several weeks. This weight gain results in swelling in your extremities and 
can result in accumulation of fluid in the lungs that can cause shortness of 
breath. Shortness of breath is common and you may require oxygen during some 
portion of this treatment. Other side effects include fever and chills that 
generally canbe eliminated by use of appropriate medications. You also might 
develop nausea, diarrhea, a skin reaction with itching, nasal congestion and 
abnormalities in kidney and liver function. You also may develop confusion 
ranging from forgetfulness to disorientation. Other possible side effects 
include feelings of tiredness and dry mouth. Some patients develop very high 
fevers and very rarely a hole in the intestine (perforation) may occur. It is 
also possible that your blood counts may drop and that you might require red 
blood cell and platelet transfusions. 
It is very unlikely, though possible, that this treatment could cause your 
death. This treatment can also cause heart p roblems including low blood pressure, 
abnormal heart beats, damage to the heart, and in some instances heart attacks. 
In previous studies these side effects have been transient and have returned to 
normal after discontinuing the administration of interleukin- 2 . Other unknown 
side effects may occur. The side effects related to IL-4 treatment include weight 
gain, nausea, vomiting, nasal congestion and occasional irritation of the stomach 
(gastritis) or ulcer with bleeding. 
For the administration of these substances it may be necessary to place a 
plastic tube (catheter) into a vein either on the upper chest wall or in the neck 
that will be threated into a central vein in the body. Other intravenous needles 
may be needed in the upper extremities. This care may be performed in the 
Intensive Care Unit. Placement of these catheters may injure the lung rarely 
requiring that a chest tube be used to evacuate the air. 
You will be required to return to the University of Pittsburgh for follow- 
up studies at two and four weeks after treatment. It is possible that the 
treatment will be repeated every four weeks or until the disease progresses. 
If your disease recurs after treatment in this protocol then you will be 
eligible to be considered for other protocols at the University of Pittsburgh and 
you will receive treatment 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. 
Your records may be reviewed by organizations outside the University of 
Pittsburgh, such as commercial companies producing the drugs. Your privacy will 
be protected in any recording or reporting of this information. 
(II 
Patient's Initials 
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Recombinant DNA Research, Volume 14 
