FEB 2G '94 0i:i9Pn SMITH RESEf«CH TOWER 
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under the skin, where we hope they will activate the body's Immune system to kill 
tumor cells that remain in your (your child's) body. 
The number of modified tumor cells that can be injected without serious side effects 
will be determined by giving the first group of patients a dose thought to be tolerable 
based upon experience with injecting other types of tumor cells. If this first dose does 
not cause side effects, a second higher dose will be tested. Since this study begins 
with a relatively low dose of tumor cells for safety reasons, you (your child) may not 
receive the highest dose that has manageable side effects and that has the most anti- 
cancer action. 
POTENTIAL BENEFITS 
The potential benefit of this treatment is that it may kill neuroblastoma tumor cells in 
your (your child's) body. However, the response of patients may vary, and your (your 
child's) tumor may grow during or after this treatment program. Knowledge gained 
from this clinical study may help other children by improving the treatment of cancer 
in the future. 
STUDY PLAN 
The gamma interferon modified neuroblastoma cells will be prepared in the laboratory 
under sterile conditions. If possible, tumor cells from you (your child), will be 
prepared; if not, those from another child with neuroblastoma will be used. These 
cells will be tested to insure that they are free of known harmful infections. 
The modified tumor cells will be injected under the skin at two sites (either the upper 
arms or thighs) on one day at week 0, 2, 4, 8, 12. 24, and 36. This will be done In 
the outpatient clinic unless side effects occur which require closer monitoring of you 
(your child) in the hospital. Injection of modified tumor cells will be stopped if severe 
side effects (toxicities) occur, and you (your child) will be treated with supportive care 
until the toxicity resolves. At that time, options of other experimental treatments or 
no further therapy will be discussed with you (your child), but no further injections of 
gamma interferon modified neuroblastoma cells will be given. If tumor grows while 
you (your child) are receiving this therapy, then you will be offered these same 
options. 
Whether you (your child) do or do not (does or does not) complete the planned number 
of Injections, life-long contact will be maintained with you to obtain information about 
possible effects of this treatment. If, unfortunately, you (your child) pass(es) away, 
an autopsy will be requested to obtain information about possible effects of this 
treatment. 
REQUIRED TESTS 
A number of examinations will be necessary before and periodically during this 
treatment program. These will include usual blood tests to evaluate normal organ 
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