paralysis. Also, if the procedure involves the heart or lungs, an 
abnormal heart rhythm may occur, requiring treatment. 
The usual complications, which we would consider minor but which 
nevertheless can be distressing to the patient, are accumulation of blood 
in the tissues where the catheter has been introduced (hematoma) , or a 
small bulge of the artery at the site where it was entered by the 
catheter. If you desire, these will be discussed with you. 
Unfortunately, this information may have alarmed you, but we believe 
it to be in your best interest to understand what is involved. Any 
questions you have about the above material can be directed to Dr. Nabel, 
or the physician or the radiologist performing the angiogram. Before 
proceeding, we request your authorization as indicated below. 
Before receiving this treatment, you will receive many tests to 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 and 3) a blood test for the 
antibodies to Human Immunodeficiency Virus (HIV) , which causes AIDS. If 
you have antibodies to HIV, you may not participate in this study. 
I 
If you qualify for this study, we will inject a solution 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 f 
to 10 times. Blood samples (between 1-10 tubes) will be obtained daily at t 
first, then weekly for the 1st month, and biweekly for the next month. 
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 2 weeks up to 4 times. 
RISKS AND SIDE EFFECTS j 
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 
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Recombinant DNA Research, Volume 17 
