be mixed with fat bodies called liposomes, and we plan to transport the 
mixture into your tumor by needle injection. Once introduced into the 
tumor, the DNA produces proteins which stimulate tissue rejection. One 
protein — known as HLA-B7 — causes the cells which will contain it to be 
recognized as "foreign enemy" by your immune system and, in some cases, a 
second protein, called interleukin-2, will be made. This protein also 
causes activation of your immune system. The purpose of our study is to 
determine whether this treatment will induce the cells of your immune 
system, known as lymphocytes, to attack and kill your tumor. This type of 
therapy which stimulates your lymphocytes is called immunotherapy. 
Alternative Therapies 
There are no known cures for patients with your disease. Other 
alternative treatments available to you can control local symptoms. These 
include the delivery of x-ray treatment to sites of local disease to 
control pain, medication to control pain, and medical, surgical, or 
1 radiation treatment of any reversible complications. Experimental drugs 
are being evaluated at other centers to which you can be referred. 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, 
which are taken to the laboratory for genetic manipulation, and 
subsequently returned to you by 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 5 times. The time of treatment is usually -30 minutes. The treatment 
will be repeated every 2 weeks for a total of three. Blood samples 
(between 1-10 tubes) will be obtained daily at first, then weekly for the 
1st month, and biweekly for the next month. A CT scan will be performed 
before initiation of treatment and at the end of the 2-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 2 weeks up to 4 times. 
Recombinant DNA Research, Volume 17 
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