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 
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 
We would like to deliver this treatment through a tube or catheter in 
your blood vessels. In this procedure, a small tube (catheter) is 
introduced into one or several of your blood vessels. Through this tube, 
a solution containing iodine (contrast medium) will be injected, which 
will enable us to see the blood vessels of the tumor on x-rays. After the 
vessel which supplies a tumor nodule in your lungs is identified, we will 
inject the genetic material complexed to fat particles that will allow 
HLA-B7 protein to be made in an attempt to stimulate your body to attack 
this nodule. The tube is introduced into the blood vessels, either in 
your arm or your groin, by means of minor surgery under local anesthesia. 
The entire procedure will take 1-3 hours to perform, of which the gene 
transfer will take ~15 minutes. It will be repeated at 2-week intervals 
for a total of three times. Although the possibility of clotting the 
vessel used is small, it does happen occasionally. In addition, it is 
possible that an artery or arteries feeding an organ could also be 
clotted. In either of these circumstances, it may be necessary to perform 
surgery to remove the clot or to treat you with certain medications which 
may dissolve the clot. We are sure you realize that although the risk is 
very small, clotting the blood supply to an organ can result in the loss 
of that organ. The overall serious complication rate is about 1 in 500 
patients. Very rarely, a serious complication can result in death. 
During the procedure, it is possible that the contrast medium might 
result in an adverse reaction, causing hives, shortness of breath, 
extremely low blood pressure, and very rarely, temporary or permanent 
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