In other words, you could have the surgery without taking part in this 
study. The benefits of surgery are to prevent future health problems of 
spread of the kidney cancer that cause pain, bleeding, and blockage of 
blood flow from the legs. 
To receive the surgery for this study, you will be examined and tested 
for good health except for the cancer. We will test your blood for HIV. 
If you have the HIV virus, you cannot take part in this study. If you are 
a woman of childbearing years you will be tested for pregnancy. If not 
pregnant, you will be prescribed birth control measures for the study. If 
you are pregnant, you cannot take part as we do not know what side effects 
the study could have on an unborn child. 
If, after surgery, you do not have kidney cancer under the microscope, 
your doctors will discuss treatments for the disease that is found in your 
kidney. After surgery, we will collect cancer cells from your kidney and 
send them sterilely to a special laboratory. One day after surgery, one of 
the two types of cell preparation for your cells will be assigned by the 
randomization -- coin flip. The sterile preparation of kidney cancer cells 
has been successful 8 times in 10. If the cell preparation is unsuccessful 
in anv wav, you will he told this right away and offered other treatment 
options bv vour doctors. 
Three weeks after your kidney is removed, you will be examined by your 
doctors and receive further blood and urine tests to see if it is safe to 
start the shots. If there are complications after surgery which make 
experimental shots unsafe, you can continue your care in the Oncology 
Center. If it is medically safe to start, you will be given your first 
injection of cells under your skin between 28 and 42 days after your 
surgery. Your first injections will be given to you in the hospital so you 
can be observed for 24 hours after the injection. If you do not have 
serious side effects, you can get shots two more times. The shots will be 
28 days apart as an outpatient in the Oncology Center. These shots will be 
given to you on your arm or thigh. Early in the study, you will be given 
four shots, and if you take part later in the study we will try to increase 
the dose by giving up to sixteen injections. The number of injections will 
depend on when you enter the study. If there are not enough of your 
prepared cells for *16 injections, we will give you as many as possible to 
use your prepared cells. If your cancer shows signs of shrinking after the 
injections, you can continue injections until the cells are used up, if no 
side effects make this unsafe. If your disease worsens, you will be told 
and other treatment options will be discussed. 
During this study, you will receive a number of medical tests to see 
if the cells are causing side effects or are doing anything to your cancer. 
Blood tests (about 6 tablespoons per week) and urine will be tested weekly. 
Skin biopsies will be taken during the first and third time you are 
injected. At most, this requires the use of local skin numbing medicine as 
an outpatient. It will make a hole in the top layer of your skin about the 
size of this letter o and be twice as deep as two quarters are thick. 
These biopsies are a routine test in dermatology and are unlikely to cause 
you any complication except a bandaid. They generally take about 5 minutes 
to do. If a gland in your groin swells to a point your doctors think it 
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