Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
MARROW HARVEST AND MARKING 
Before the high-dose chemotherapy starts, we will remove a small part of your (your child’s) 
bone marrow from the hip bone. This will be done in the operating room under general 
anesthesia. You (your child) will not feel anything when the marrow is taken. There may be 
some pain later. You (your child) will be given medicine for the pain. 
If you (your child) agree to be in the "marker" study, we will mix approximately two-thirds of 
the marrow with two special viruses (one-third of the marrow with each virus) before we put 
the marrow back into your (your child’s) body. We will use mouse viruses that have been 
changed to keep them from causing infection. The marker, a bacterial gene called "NEO R ", is 
put inside these special viruses. 
RISKS 
No bad effects have been seen in animal studies using these markers or in any person treated 
with marker genes. Still, there may be risks. It is possible that the mouse virus might 
"recover" in the cell and be able to grow; it might even cause cancer. We think this is very 
unlikely but we cannot rule it out yet. 
BENEFITS 
The benefits of this marker study would be a better understanding of neuroblastoma and of 
marrow transplants. This would help us plan better ways of treating neuroblastoma. If you 
(your child) needed another transplant in the future, these changes might help you (your child). 
Otherwise, what we learn might lead to better treatment for other patients with this disease. 
So that we can study the marked cells, we will take a little extra blood after the marrow is put 
back. The extra blood taken will be about 20 mL (1 tablespoon) once or twice a week for 6 
weeks. We will also take extra blood monthly for 6 months, every six months for 2 years, and 
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Recombinant DNA Research, Volume 16 
