3. Description of Research. 
This is a Phase I trial designed to determine if the injected material is 
toxic to patients with melanoma. The injected material consists of melanoma 
cells from another patient that have been modified genetically so that they 
secrete interleukin-2 (IL-2) . IL-2 is a protein made by certain blood cells 
that can stimulate immunity. In earlier studies, cancer patients received 
large doses of IL-2. Some of these patients had reductions in the size of 
their tumors. Most of them experienced side effects. Sometimes these side 
effects were severe. Many of the side effects were a result of using very 
high doses of IL-2. This new technique will use much smaller doses of IL-2 to 
stimulate your immune system. We hope to determine whether or not this 
treatment is toxic, rather than how effective it is in treating your cancer. 
Other options for the treatment of melanoma include chemotherapy, surgery, or 
radiation. You should feel free to discuss these options with one of your 
doctors. However, you are being offered this treatment because your tumor has 
not responded to standard treatment. 
The tumor cells used for injection are stored melanoma cells from another 
patient with melanoma. These tumor cells have been induced by genetic 
modifications to produce IL-2. The altered cells now make IL-2. They will be 
X-rayed to prevent growth of the tumor cells in your body. This is the 
material you will receive, given into and under your skin in the arm or thigh. 
Your injections will be administered in the Surgical Oncology Clinic of the 
University of Illinois Hospital. You will receive a total of four series of 
injections. For the first four course of injection, you will be admitted to 
the hospital for 23 hours of observation. You will not be responsible for 
hospitalization charges related to this one day period of observation. Blood 
tests will be performed before each series of injections. For this, a sample 
of blood (one or two ounces) is drawn from your vein before and after the 
injection. The blood is used to assess the response of your immune cells to 
the injected cells. At various intervals for the first four weeks and then 
monthly, you will need to be seen by your doctor for examinations. X-rays and 
scans will be taken before and after the injections to see whether the size of 
your tumor has changed. 
After the first four courses, further injections will depend upon how your 
tumor responds and what kind of side effects you have. If you experience 
severe side effects, the injections will be stopped. If your tumors get much 
bigger or if new large-sized tumors develop, the injections may also be 
stopped. We cannot assure you that further injections with additional 
genetically modified cells will be possible, even if your tumor responds to 
the prior injections. 
The dose of the IL-2-producing tumor cells will be varied. The first six 
patients in this research study will be treated with a standard number of 
tumor cells. If they have no adverse side effects, the next group of patients 
will be given a higher number. 
Recombinant DNA Research, Volume 18 
