This phase I study is the first to employ the GM-CSF gene, and 
first to use the MFG retroviral vector, the engineered mouse virus 
GM-CSF gene delivery system. 
The cells used to produce the viruses carrying the GM-CSF 
gene in the laboratory already have passed FDA inspection and have 
been shown not to make any viruses other than those which are 
designed to insert a gene of interest into the DNA of a cell of 
interest. Studies are ongoing at the University of Michigan with 
this gene transfer system. No side effects from the release of 
unwanted viruses has been observed so far in patients treated 
there. If these viruses should be changed in some way, they could 
in theory cause additional cancers in your body. 
In the case of this study the injected cells carrying the 
transfered GM-CSF gene are destroyed under the skin in the normal 
process inflammation following injection. This builds in an 
additional safety feature. Nevertheless, the long-term side 
effects of all aspects of using the GM-CSF gene transfer are not 
known and it is important for you to be aware of this. 
Humans kidney cancer cells appear different than the mouse 
kidney cancer model studied which led to this trial. Human kidney 
cancer cells do make some GM-CSF as they are prepared for 
injection. The GM-CSF gene transfer increases this by 10 to 20 
times, but it is not known what the side effects could be in humans 
from this when the cells are injected. To study the side effects 
of each form of cell preparation, one without GM-CSF gene transfer 
and one with GM-CSF gene transfer, patients who take part in this 
studied will be injected with one preparation or the other. 
You will not be injected with both because this would confuse the 
study of which side effects come from which preparation. 
D. Study Procedures 
If you decide to participate, you will read and sign a 
separate informed consent form for the surgery as all patients do 
for nephrectomy at Johns Hopkins. If at surgery, the cancer is 
diagnosed as renal cell cancer, you will be finally eligible for 
injections of the prepared cells. Once your own tumor cells are 
cut out, they will be sent (much like a human organ for transplant) 
to the laboratories of Somatix Therapy Corporation who are working 
with your doctors at Hopkins. With the doctors at Hopkins, Somatix 
Therapy Corporation has received permission from the Food and Drug 
Administration to prepare the cells for experimental therapy. 
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