RISKS AND SIDE EFFECTS 
There are potential side effects and risks to this procedure. First, 
you may experience mild discomfort from needle injections or tumor 
biopsies. You may have mild discomfort and bleeding from the tumor 
biopsy. You will be given a local anesthetic to minimize the discomfort. 
Second, even though the DNA inserted into your tumor is considered 
harmless to you, events could occur within normal cells that allow them to 
become cancerous. Laboratory studies suggest that this possibility is 
unlikely. However, this is a new procedure and we do not know whether 
cells could become abnormal after long periods of time. In animal 
studies, we have not observed the development of cancer cells in any 
animals tested. Third, the inserted DNA will contain a gene that 
inactivates certain antibiotics in bacteria. This protein is not likely 
to be made in humans, and many other antibiotics that are not inactivated 
will be available and effective in treating any potential bacterial 
infections . 
We emphasize that this procedure, called direct gene transfer, has 
never been used before in human patients. Because this procedure is new, 
it is possible that despite our extensive efforts, other unforeseen 
problems may arise, including the very remote possibility that death may 
occur. 
You will undergo biopsy of tumor and other tissue, if available, on 
several occasions before and after injection. Blood and tissue specimens 
will be taken where possible to follow the duration and effects of HLA-B7 
expression. If we are successful in this protocol, you will be immunized 
to the HLA-B7 protein. In the event that you should require an organ 
transplant, you would not be able to receive an organ from an individual 
who makes this protein, on average, ~15% of donors. 
Follow-Up 
After you receive the treatment, you will be discharged from the 
hospital if you have no other significant medical problems. You will be 
required to return to the University of Michigan Medical Center for 
follow-up studies described above. Tests used to decide if your tumor has 
responded to the therapy will be similar to those you had before beginning 
the therapy. If your disease recurs after treatment in this protocol, you 
will be eligible for other protocols and will receive treatment as 
indicated by your disease or referred elsewhere for such treatment. 
Because this form of therapy is new, unanticipated side effects that may 
cause your condition to deteriorate could be encountered. You will be 
closely monitored for such side effects. 
Treatment will continue as long as there is sufficient possibility of 
response to warrant the risks and side effects encountered. Your 
physicians feel that the risks of your disease are much greater than the 
risks of the treatment as outlined above. Furthermore, your physicians 
have considered your 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 
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