Attachment II 
CHILDREN’S ASSENT FORM 
I have been asked to take part in a study designed to test a new treatment for 
neuroblastoma, a type of childhood tumor. My doctors have told me that I have 
neuroblastoma, and that (1) although there is no evidence for disease now, there is a 
possibility the disease may return, or (2) that there is still tumor left after usual treatment. I 
am, therefore, being asked to try a new experimental treatment to help destroy remaining 
cancer cells. The treatment is called gene therapy. My cancer cells, or cancer cells from 
another patient with neuroblastoma, have been growing in the laboratory and have been 
specially altered to make gamma interferon, a substance which may help my immune 
system recognize and fight the cancer cells. If I agree to take part in the study, I will 
receive injections containing tumor cells that have been treated with radiation to prevent 
them from growing, under the skin, seven times in nine months. My doctors will follow 
me carefully to see if 1 have any bad or good effects from the injections. They hope the 
injections will "teach" my own immune system to destroy tumor cells. 
They will examine me every week for four weeks and every month after four weeks. They 
will draw blood before every tumor cell injection and will obtain several special tubes 
(20 ml — four teaspoons of blood) to find out how my immune system is doing before the 
first injections, and at week 8, week 24 and week 36. 
It is possible that I may have some bad effects called "side effects" from these injections. I 
may feel pain where the injection is given, a sore may form at the site, I may develop a skin 
rash, fever, chills, muscle aches, or feel tired. There may be other side effects that I cannot 
be told about in advance, because this type of treatment has not been tried before in people. 
My doctors hope that this therapy will kill my tumor cells, but the therapy may not work. 
If I have any questions, I may call Dr. Joseph Rosenblatt, at (310) 825-2745, or my 
U'eating physician at any time. 
I may keep a copy of this assent form if I like. 
Date 
Informant (Investigator) 
Your Signature 
Date of Expiration: January 6, 1995 
Recombinant DNA Research, Volume 19 
[107] 
