of using very high doses. This new technique will use much smaller doses of 
interleukin-2 to stimulate your immune system to fight your tumor. 
Other options for the treatment of melanoma include chemotherapy, experimental 
immunotherapy, surgery or radiation therapy. You should feel free to discuss these 
options with your doctor. However, you are being offered this treatment because 
your tumor has either not responded to standard treatment or known effective 
treatments are not available. 
DESCRIPTION OF THE RESEARCH PROCEDURES 
The tumor cells used to make the vaccines are stored melanoma cells from one 
patient with melanoma. These cells show a protein called HLA-A2, the same 
protein that you have been demonstrated to show and that your melanoma is 
thought to show. These tumor cells have been induced to produce interleukin-2 by 
gene therapy. Now, these altered cells can make IL-2 and will be x-rayed to 
prevent their growth of the tumor cells and insure sterility. This is the vaccine you 
will receive, given into and under your skin in the arm or thigh. 
Your vaccinations will be administered in the outpatient unit of Memorial Hospital. 
You will receive a total of four vaccinations. Blood work will be taken prior to 
each vaccination. In addition, a sample of blood (one to two ounces) is drawn 
before and after the vaccinations to assess the response your immune cells have 
had. Every two weeks for the first four weeks and then monthly during your 
treatments, you will need to be seen by your doctor for examinations. X-rays and 
scans will be taken before and after the vaccinations to see whether the size of your 
tumor changes. 
Gf 
After the first course of treatment, further treatment will depend upon how your 
tumor responds and what kind of side effects you have. If severe side effects are 
seen, then the treatment will be stopped. If your tumors get much bigger or if new 
Jarge-sized tumors develop, treatment may also be stopped. We cannot assure you 
that, even if your tumor responds to therapy, further treatment with additional 
vaccine will be possible. 
The dose of the interleukin-2 producing tumor cells in the vaccine will be 
varied. The first six patients in this research study will be treated with a dose 
of tumor cells. If they have no adverse side effects, the next group of patients 
will be given a higher dose. 
It is not yet possible to say how helpful the vaccination treatments will be in 
shrinking melanoma, or what the optimal dose of altered tumor cells should be. 
Recombinant DNA Research, Volume 15 
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