by cells of your immune system, called lymphocytes. The purpose is to 
determine whether this treatment will stimulate your immune system cells 
to attack and kill your tumor. This type of therapy which stimulates your 
lymphocytes is called immunotherapy. 
Alternative Therapies ; j 
There are no known cures for patients with your disease. Other 
alternative treatments available to you include radiation or medication to 
control pain and medical, surgical, or radiation treatment of any 
reversible complications. Other experimental treatments are under 
investigation which attempt to stimulate your immune system to reject your 
tumor, and you can be referred to physicians who are conducting such 
trials. In contrast to this treatment, other protocols usually require 
removal of tumor cells or blood cells, laboratory manipulation, and re- 
injection. In some cases, proteins are injected which can stimulate the 
immune system. You also have the option to receive no treatment at this 
time. 
Procedures 
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. 
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 
to 10 times. Blood samples (between 1-10 tubes) will be obtained daily at 
first, then weekly for the 1st month, and monthly for the next 6 months. 
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. 
i 
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 2-6 weeks up to 4 times. 
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 gene will make a protein that 
inactivates certain antibiotics. These antibiotics are not usually used 
[456] Recombinant DNA Research, Volume 15 
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