aware that there is a remote chance that the use of this virus may cause a new cancer. Because this 
procedure is relatively new, it is possible that despite extensive precautions, other unforeseen problems 
may occur including the very remote possibility of death. 
The gene-modified tumor cells I will receive are designed to produce an immune hormone called 
IL-4. This hormone is naturally produced in the body in small amounts. However, the gene-modified 
tumor cells which are injected into my skin may produce too much IL-4. This might lead to side effects 
which include fatigue, flu-like symptoms, diarrhea, nausea, loss of appetite, headache and fluid retention. 
I will be monitored for this possible side effect by obtaining blood samples on a periodic basis to measure 
IL-4 levels. If it becomes apparent that I am experiencing problems related to IL-4 production by the 
tumor cells, they will be surgically removed. 
Lymph node cells/IL-2 infusions: 
For the administration of my lymphocytes it will be necessary to place an intravenous catheter 
through a vein either on the upper chest wall or in the neck that will be threaded into a central vein in the 
body. The risks involved in having such a central venous catheter include collapse of the lung, infection, 
or development of a blood clot in the vein. Infusion of the cells into my vein is performed over a 30 
minute period. The administration of these cells may cause side effects including fever, chills and some 
shortness of breath but I have been informed that these effects last for only a few hours. 
I am aware that the administration of IL-2 can cause significant side effects. These include weight 
gain from fluid retention, shortness of breath, a drop in blood pressure, infections, nausea, diarrhea, 
confusion, abnormal heart beats, and abnormalities of liver and kidney function. I have been informed 
that these side effects require close monitoring in the hospital. If any serious side effect occurs I 
understand the treatment will stop and appropriate medical actions will be taken. I am aware that treatment 
with IL-2 may cause my death. Less than 1% of patients who have received IL-2 have died as a result of 
the treatment. 
FOLLOW-UP 
After I receive the treatment, I will be required to return to the University of Michigan Medical 
Center for follow-up studies approximately four and eight weeks after hospital discharge. Tests used to 
decide if my tumor responded to the therapy will be similar to those I had before beginning the therapy. I 
will also undergo skin testing at these time intervals as well as prior to treatment. Some of these skin tests 
will be done to determine if I react to my own tumor cells. This will involve the injection of irradiated 
tumor cells in my skin. If my disease worsens after treatment in this protocol, I will be eligible for other 
protocols and will receive treatment as indicated by my disease or referred elsewhere for such treatment. 
Because this form of therapy is new, unanticipated side effects that may cause my condition to deteriorate 
could be encountered. Therefore, I agree to be monitored for such side effects for the rest of my lifetime 
by the research investigators of this study.. 
By two months after treatment, if I have evidence of tumor shrinkage or my tumors remain 
unchanged it is possible that additional treatment will be offered. I understand repeat treatment would 
consist of receiving additional lymph node cells which had been frozen and stored from my initial 
procedures; along with the administration of IL-2. Repeat treatments would not entail any further surgical 
procedures to remove tumor or lymph nodes. If lymph node cells are not available, I will be offered 
treatment with IL-2 alone. My physicians feel that the risks of my disease are much greater than the risks 
of the treatment as outlined above. Furthermore, my physicians have considered my individual situation 
and have concluded that, at this time, no other therapeutic approaches such as surgery, radiation therapy or 
other chemotherapeutic treatments are clinically indicated as being more effective. At some later time, 
should these alternatives be clinically indicated, they will be discussed with me because this study does not 
preclude their use. 
Due to the nature of this study which involves the genetic alteration of some of my tumor cells, I 
have been informed that vital information could be obtained from an autopsy examination in the event of 
death at any future time. I grant permission for this examination. However, I reserve the option to 
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Recombinant DNA Research, Volume 18 
