15.0 SUMMARY STATEMENT 
You have (your child has) neuroblastoma that has come back, or not gone away, after 
treatment. The cancer is harder to treat now. We would like you (your child) to be in a 
research study of treatment designed to make your (your child’s) own immune system fight 
the cancer. To do this we will put a special gene into cancer cells taken from your (your 
child’s) body. This gene makes the cancer cells produce IL-2, a natural substance that may 
help the immune system kill cancer cells. Some of these cells will then be put back in your 
(your child’s) body. Studies of cancers in animals and in cell lines suggest that substances like 
IL-2 do help the body kill cancer cells. This treatment has not been used before in children, 
but similar treatments are being used in adults with other cancers. Because we do not 
know whether this treatment will work against your cancer, this is a research study. Also, we 
do not know the best amount of these special cells to use, so different children will get 
different numbers of cells. The purpose of the study is to learn the side effects and safe 
"dosage" of these special cells and to see how well the treatment works against 
neuroblastoma. 
TREATMENT 
We will first need to test your (your child’s) blood for HIV, the virus that causes AIDS. If 
this virus is present, this treatment cannot be used. By signing this statement, you are 
agreeing to the HIV testing. 
Before treatment starts, cancer cells taken at diagnosis will be grown in the laboratory. We 
will then put a mouse virus inside the cancer cells. This special virus has been changed to 
keep it from causing infection. It has also been changed to add two new parts-a "marker" 
gene called NEO R (taken from bacteria) and the IL-2 gene (which comes from humans). 
The marker lets us tell these cells apart from other cells, and the IL-2 gene is meant to help 
the immune system fight the cancer. The modified cancer cells will be injected under the 
skin. There will be two shots, one week apart. The second shot will have 10 times as many 
cells as the first. You will normally have these shots as an outpatient. 
TESTS DURING AND AFTER TREATMENT 
Before the second shot, and then again about 2 weeks later, we will remove some of these 
modified cells from your body and study them. We will do this by a skin biopsy at the place 
where the cells were injected. These tests are to see whether the changes made in the 
laboratory are killing these cancer cells. 
To study how the immunity is working in your system, we will take blood samples once a 
week for 6 weeks, once every 2 weeks for 6 weeks, and then once a month for a year. These 
samples (about 1 1/2 tablespoons of blood) will come from the central line, so extra "sticks" 
should not be needed. You (your child) will need to come to the clinic on the days when we 
take blood. 
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Recombinant DNA Research, Volume 15 
