FEE 26 '94 0i:iBPn SMITH RESERRCH TOWER 
P.9/14 
CHILDRENS HOSPITAL LOS ANGELES 
INFORMED CONSENT 
A CUNICAL STUDY PROGRAM USING HUMAN GAMMA INTERFERON TRANSDUCED 
NEUROBLASTOMA TUMOR CELLS TO IMMUNIZE PATIENTS WITH HIGH RISK 
NEUROBLASTOMA WITH PERSISTENT OR PROGRESSIVE DISEASE 
BACKGROUND AND PURPOSE 
Children with neuroblastoma that is very difficult to treat ("high risk neuroblastoma"), 
who have persistent or new tumor growth ("progressive disease") during or following 
treatment are eligible for participation in this experimental treatment program (a phase 
I study). Neuroblastoma cells that have been modified to make gamma interferon will 
be injected under the skin in an attempt to stimulate the immune system. The main 
goals of this study are to determine 1 ) the dose of modified neuroblastoma cells that 
can be injected without serious side-effects; 2) the response of the immune system 
to the injected tumor cells. Although we hope that this immunologic therapy will 
stimulate the immune system to kill tumor cells, there is no guarantee that this will 
occur. 
You (your child) have (has) high risk 
neuroblastoma that was diagnosed before 21 years of age. Nearly all children with 
neuroblastoma that has persisted or regrown despite treatment with chemotherapy, 
radiation, and surgery do not survive their disease. The immune system, if properly 
stimulated, may be able to kill tumor cells. Therefore, we are testing whether a 
response against the tumor is stimulated by neuroblastoma cells that have been 
modified to make gamma interferon. The first question to be answered in this clinical 
study is whether injecting modified neuroblastoma cells causes severe side effects. 
We are offering you (your child) participation in this study because you (your child) still 
have(has) tumor cells that are growing. The results of this study will provide 
information helpful in the further development of immunologic treatments for 
neuroblastoma. 
Neuroblastoma cells used in this study are obtained from a tumor mass, bone marrow, 
or blood of you (your child) or another child and grown in the laboratory. Next, they 
are modified by putting in DNA for the human gamma interferon gene. A gene is a 
piece of DNA that is found inside ali cells and that carries information for a cell to 
make a protein product. Neuroblastoma cells that have been given the gene for 
gamma interferon make gamma interferon protein, which can change them and 
possibly activate the immune system. The DNA that makes gamma interferon is put 
into the tumor cells by infecting them with a weakened mouse virus which carries this 
DNA. This virus (called a vector), which is produced in the laboratory by cells from 
a dog, has been weakened so that it will not grow and cause a viral infection in other 
cells besides the tumor cells. The tumor cells that carry the new gamma interferon 
DNA are irradiated so they will not grow and form tumors. Then they are injected 
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