MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
N1H 2514-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER: 
CONTINUATION: page of page: 
from the sternum (breast bone). It is then frozen and stored in liquid nitrogen. Because many 
needle punctures are needed, the procedure is performed under general anesthesia in the • 
operating room. The risks of this procedure include bleeding, infection and pain. You will 
receive 3 to 4 units of blood transftision during the procedure and this may place you at a small 
risk for hepatitis. Your consent for general anesthesia will be obtained after discussion with the 
anesthesiologist. 
In order to qualify for this protocol, a minimum number of bone marrow cells must be 
removed so we can safely perform the transplant procedure. There is the possibility that we may 
not be able to remove enough bone marrow cells to do this. If insufficient bone marrow cells can 
be obtained to make a transplant safe, you will be considered for treatment on other NCI 
protocols. 
THERAPY ON STUDY 
If you are eligible for and decide to accept treatment on this protocol, your bone marrow will 
be removed as described above and you will be treated over a 4 day period with three drugs 
called ifosfamide, CBDCA and etoposide (ICE) administered as follows: CBDCA will be 
administered as a constant intravenous infusion over 3 days (72 hrs); ifosfamide will be 
administered intravenously over 2 hours each day for 4 days; etoposide will be administered 
Intravenously over 1 hour twice a day for 3 days. These drugs will be administered through your 
Hickman catheter. Two days after the chemotherapy is completed, your bone marrow will be 
given back to you through your Hickman catheter like a blood transfusion. Both normal, 
unchanged bone marrow and the marrow containing the neo gene will be returned to you. One 
day after your bone marrow is given back, you will start treatment with G-CSF, a protein factor 
give to you daily as an under the skin injection to help your blood counts return to normal. 
G-CSF will be stopped when your blood count returns to the safe range. You will be 
hospitalized for 4 to 6 weeks following the transplant 
You will be hospitalized for the bone marrow transplant. Following treatment with ICE 
chemotherapy over four days, the frozen bone marrow will be thawed on day 7 and infused 
intravenously (like a blood transfusion). Beginning on day 8, you will be treated with a daily 
injection under your skin of G-CSF to help your blood counts recovery more quickly. The bone 
marrow suppression caused by the chemotherapy should be reversed by the bone marrow 
transplant and most patients recover their white blood cell and platelet counts to a safe range in 
three to four weeks following marrow reinfusion. The G-CSF will be stopped once your blood 
counts recovery to the safe range. You will be hospitalized until your blood counts are in a safe 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-251 4-1 (10-84) 
NIH-251 4-2 (10-84) P.A.: 
09-25-0099 
Recombinant DNA Research, Volume 16 
[129] 
