Informed Consent 
PARENT’S/PATIENT’S SUMMARY STATEMENT 
I USE OF DOUBLE MARKING WITH RETROVIRAL VECTORS TO DETERMINE RATE 
! OF RECONSTITUTION OF UNTREATED AND CYTOKINE EXPANDED CD34 + 
i SELECTED MARROW CELLS IN PATIENTS UNDERGOING AUTOLOGOUS BONE 
I MARROW TRANSPLANTATION 
You have consented for an autologous bone marrow transplant as part of the treatment for 
! your/your child’s cancer. In this procedure strong chemotherapy is given to kill any cancer cells 
! that may be left. Then, a bone marrow transplant will be done using your (your child’s) own 
bone marrow. This is necessary because the chemotherapy also kills normal cells in the 
' marrow. 
; TREATMENT OF MARROW BY CHOOSING STEM CELLS AND USING GROWTH 
I FACTORS WITH GENE MARKING 
I After autologous bone marrow transplant there is a risk of infection and bleeding while the blood 
counts are low before the new marrow grows back. In this study we would like to find out if 
we can make the marrow grow faster after we put it back by mixing it with special proteins 
I called growth factors. To do this, we will split the marrow into three parts. One part will be 
frozen without treatment as a safety backup. The other part will be separated on a machine 
which picks out cells called stem cells which grow up to be normal marrow cells. We will split 
! the stem cells into two parts and put a different marker gene into each of them. One marked part 
will then frozen without more treatment, and the second will be given growth factors to try and 
I make the marrow grow faster. Both parts of the stem cells will then be returned to you/your 
child. We will then look to see if the treated part of the marrow grows back faster and stronger 
than the untreated part. Each step of the treatment plan is given below. 
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 agree (your child agrees) to be in this study, we will freeze about one-third of the marrow 
with no treatment. This bone marrow will be saved as "back up" bone marrow to be given to 
you (your child) just in case the first bone marrow does not t^e. Stem cells will be picked 
from the rest of the marrow and half will be marked with LNL6 and half with GIN. These are 
the names of special mouse viruses that have been changed to keep them from causing infection. 
The marker, a bacterial gene called "neoR", is put inside these special viruses. One half of the 
marrow will then be frozen immediately and the other will be cultured in growth factors for 5-7 
days and then frozen. Both parts will then be put back through you/your child’s central line after 
the chemotherapy is finished. The markers let us follow the treated marrow in your (your childs) 
body to see if treatment with growth factors makes the marrow grow back faster. 
Recombinant DNA Research, Volume 19 
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