ASSENT FORM FOR PATIENTS AGED 7-18 
USE OF DOUBLE MARKING WITH RETROVIRAL VECTORS TO DETERMINE RATE 
OF RECONSTITUTION OF UNTREATED AND CYTOKINE EXPANDED CD34 + 
SELECTED MARROW CELLS IN PATIENTS UNDERGOING AUTOLOGOUS BONE 
MARROW TRANSPLANTATION 
You are going to have an autologous bone marrow transplant as part of the treatment for your 
cancer. You will get strong chemotherapy to kill any cancer cells that may be left. Then, a bone 
marrow transplant will be done using your own bone marrow. This is necessary because the 
chemotherapy also kills normal cells in the marrow. 
TREATMENT OF MARROW BY SELECTING STEM CELLS AND USING GROWTH 
FACTORS WITH GENE MARKING 
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 medicines which 
make the marrow grow. To do this, we will separate 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 mixed with growth medicine to try and make the marrow come back faster. Both 
parts of the marrow will then be given back to you. We will then look to see if the treated part 
of the marrow grows back faster and stronger than the untreated part. 
MARROW HARVEST AND MARKING 
Before the high-dose chemotherapy starts, we will take out a small part of your bone marrow 
from the hip bone. This will be done in the operating room while you are asleep under 
anesthesia. You will not feel anything when the marrow is taken. There may be some pain 
later. You will be given medicine for the pain. 
We will freeze about one-third of the marrow immediately with no treatment. This bone marrow 
will be saved as "back up" bone marrow to be given to you just in case the first bone marrow 
does not take. 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. One half of the marrow will then be frozen 
immediately and the other will be mixed with growth medicines for 5-7 days and then frozen. 
Both parts will then be put back through your central line after the chemotherapy is finished. 
The markers let us follow the treated marrow in your body to see if the medicines makes the 
marrow grow back faster. 
BENEFITS AND RISKS 
Stem cell Selection 
We hope that stem cell picking will mean that only normal blood making cells are returned to 
you and we hope the treatment will make them grow faster. The major risk is that only a few 
stem cells are selected and the marrow will be slower. This might increase the risk of infection 
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Recombinant DNA Research, Volume 19 
