see if you qualify for this study. These tests will be made either as 
an inpatient or an outpatient. These tests include: 1) blood tests; 2) 
x-rays of the brain, chest, and abdomen; 3) a blood test for hepatitis; 
and 4) a blood test for the antibodies to Human Immunodeficiency Virus 
(HIV), which causes AIDS. If you have antibodies to HIV or hepatitis 
virus, you may not participate in this study. These initial blood tests 
require that about 45 ml (3 tablespoons ) of blood be taken. 
If you qualify for this study, we will inject the experimental 
mixture containing the DNA/liposome complex directly into a tumor 
nodule. The injections will be made under sterile conditions after 
providing a local anesthetic (xylocaine), and multiple areas within a 
single nodule will be injected up to four times. The time of treatment 
is usually -30 minutes. The treatment may be repeated every two weeks 
for a total of three. Blood samples ( about 45 ml or 3 tablespoons ) 
will be obtained daily at first, then weekly for the first month, and 
biweekly for the next month. A CT scan will be performed before 
initiation of each treatment and at the end of the two month study 
period. Your blood lymphocytes will be tested for their ability to 
respond to the HLA-B7 antigen. We will also examine your blood for 
evidence of toxicity from this treatment. 
At different times in the protocol, tumor biopsies will be 
performed. This procedure involves the injection of a local anesthetic 
(xylocaine) under sterile conditions, followed by insertion of a needle 
into the tumor nodule and withdrawal of a sample of the tumor. This 
procedure will be performed prior to treatment and at intervals of two 
weeks up to four times. 
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 after a one night stay if you have no other significant medical 
problems. You will be required to return to the University of Chicago 
Medical Center for follow-up studies described above for at least eight 
weeks after the trial has begun. It is possible that we may ask you to 
return after this time if additional tests will be needed. We also will 
maintain life-long telephone contact with you or your doctor if you are 
not receiving care at the University of Chicago so that we may check on 
your progress. 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 
Recombinant DNA Research, Volume 19 
