neuroblastoma cells are unavailable or did not grow in the laboratory. The tumor cell 
preparation is tested to determine that it is free of known harmful infectious agents. The 
irradiated tumor cells will be injected under the skin at two or possibly more sites, either in the 
upper arms or thighs on one day in week 0, and one weeks 2, 4, 8, 12, 24 and 36. I (my 
child/ward) will receive injections over a 36 week period and followed for life. Because gene 
therapy of this type is a novel form of anticancer therapy, I (my child/ward) will be followed 
through my (my child/ward's) life, and contacted at least annually to see how I (my child/ward) 
is doing. I (my child/ward) will be asked to maintain contact with the investigators and to 
provide a new address if I (my child/ward) moves. If I (my child/ward) die for any reason, 
either during or after my participation in this study, permission to perform an autopsy will be 
sought. 
Irradiated tumor cells will be given in the pediatric outpatient clinic unless significant side 
effects occur which require a closer monitoring in the hospital. Treatment will be stopped if 
severe side effects occur or if the tumor continues to grow despite administration of the 
treatment. 
Required Tests 
A number of examinations will be necessary before, during and after this treatment program if I 
(my child/ward) agree to enroll in this study. These include usual blood tests to evaluate 
normal organ function and special blood tests to measure my immune function or that of my 
child/ward. The blood test done to measure immune function will be done at study entry and at 
weeks 8, 24 and 36. Immune function tests will require the withdrawal of approximately 20 
cc's (four teaspoons) of blood. All blood tests will be drawn by vein or through a venous 
access device such as a catheter if one is available. An additional teaspoon of blood will also 
be drawn before the vaccine is given and forty-eight hours later on weeks 0, 8, 24 and 36 to 
determine the blood level of gamma interferon which is being made by the injected tumor cells. 
Other tests to be done during this treatment program include scans and radiologic evaluations to 
follow my (my child/ward) disease status. I (my child/ward) will have a bone marrow aspirate 
and biopsy performed on both sides of the hip at study entry. This procedure may cause some 
pain/discomfort and will be explained to me (my child/ward) separately by our doctors. 
Periodic repeat bone marrow examinations will only be done if my (my child/ward's) bone 
marrow test was positive for neuroblastoma at the time of entry in the study. All these tests are 
needed to measure my (my child/ward's) clinical condition, progress and immunity to the 
tumor cells. If any tumor cells are obtained from me (my child/ward) during necessary 
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Recombinant DNA Research, Volume 19 
