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. During the catheter 
procedure, there are several risks, including the potential for clot 
I formation or a reaction to intravenous contrast. These risks are 
described more fully in the previous section entitled "Procedures." 
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 
more effective. At some later time, should these alternatives be 
clinically indicated, they will be discussed with you because this study 
does not preclude their use. 
Other Pertinent Information 
| 1. Confidentiality. When results of a study such as this are reported in 
medical journals or at meetings, the identification of those taking 
part is withheld. Medical records are maintained according to current 
legal requirements, and are made available for review, as required by 
the Food and Drug Administration or other authorized users, only under 
the guidelines established by the Federal Privacy Act. A qualified 
representative of the National Institutes of Health may inspect 
Recombinant DNA Research, Volume 17 
[741] 
