therapy if the disease does not respond to IL-2 therapy, and the 
patient is still healthy enough to receive experimental drug 
treatment. Phase I therapy is experimental therapy where the study 
of the side effects of the treatment of potential new anticancer 
drugs is the chief goal; whether or not a phase I treatment works 
at all against human cancers is not known when a phase I study is 
started. Safety is studied in humans first before larger numbers 
of patients get treated to see how well the experimental treatment 
works against different cancers. 
Some patients sent to Johns Hopkins may have already been 
treated with IL-2 treatment and the tumor either did not shrink or 
continued to grow despite treatment. Some patients will not have 
received this treatment or have already chosen to try something 
else first. IL-2 carries with it a chance of complete shrinkage of 
the tumor or tumor sites seen on scans in 4 to 6 patients of 100 
treated. If this response occurs, the tumor may remain invisible 
(a remission) for over 12 months or longer. Unfortunately, IL-2 
treatment given at the full recommended doses can be extremely 
dangerous even given in an intensive care unit. The rate of death 
due to IL-2 treatment of 4 to 6 patients in 100. According to the 
Food and Drug Administration statistics, the chances of the best 
benefit from IL-2 (a complete remission) are about as likely as 
death from the treatment not the cancer. At Johns Hopkins, phase I 
therapy such as this study may come after or before IL-2 therapy 
depending on patient health at a given time and patient-physician 
discussion of risks and benefits. In other words, if you take part 
in this study and the cancer does not improve, you could then be 
treated with IL-2 therapy. 
3. THREE SCIENTIFIC ASPECTS OF THIS TRIAL FOR TESTING SAFETY 
Our group has completed many studies in mice using a strategy 
stimulating the immune system (the disease fighting system in the 
human body) to recognize RCC cancer cells and then destroy them. 
Unfortunately, many treatments which work in mice cancers do not 
work in human cancers. To move from mouse cancer research to human 
cancer therapy, safety in humans must first be proved in a phase I 
study. Three aspects of this experimental cancer treatment 
strategy are being studied from laboratory experiments. 
A. Cancer Cell Preparation for Injection 
The first aspect under study for safety is the injection of 
the patient's own tumor cells to present tumor specific antigens. 
Antigens are markers on the surface of cells that the immune system 
can recognize as disease and then send in white blood cells to 
destroy. These white cells act like "PAC-MEN", gobbling up 
cancer cells. Our group has developed conditions to grow more 
human kidney cancer cells outside the body than have ever been 
injected back into patients to try to stimulate the patient immune 
system with higher doses of antigens. A safe dose when cells are 
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