MEDICAL 
RECORD 
TONTINUATUWSflEET for either! 
Nl H 2514-1, Consent to Pertici pate i n A Cli nical Research Study 
NIH 251 4-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER. 
Continuation: page 4 of pages 
transplant to test it for drug resistance markers. If your tumor relapses or is found in a 
new part of your body after bone marrow transplant, a biopsy of this tumor will be 
obtained under local anesthesia to look for the presence of the MDR-1 gene in the 
tumor cells. The risks from these biopsies include pain, bleeding, infection or a 
punctured lung. 
After the bone marrow transplantation you may be asked to undergo apheresis 
to obtain blood cells to study whether the MDR-1 gene is inside them. This procedure 
allows for the collection of large number of white cells without removing a lot of blood, 
since most of what is withdrawn is put back. Furthermore, all of the blood that is 
returned is your own; you will not receive the blood of another individual. The entire 
procedure takes one to two hours and will be performed in the Apheresis Center of the 
NIH Blood Bank. Adverse reactions to the apheresis procedures are rare. They 
include pain and rarely fainting due to transient lowering of the blood pressure. 
Tingling sensations around the mouth, fingers or toes and mild muscle cramps may 
occasionally occur as a side effect of the blood thiner used during the procedure. 
These symptoms are easily treated by stopping the procedure or giving Turns (calcium 
containing tablets). This procedure may be performed on more than one occasion, 
depending on how long the MDR-1 gene remains in your cells. 
RISKS AND TOXICITIES 
No side effects from the MDR-1 marker gene and the non-infectious retroviral 
vector carrying the MDR-1 gene virus to be used in this protocol have been seen in 
animal studies. However, since this is a very new procedure, the risks may not be 
known. There are some theoretical risks to this procedure. First, even though the virus 
used to insert the gene into your bone marrow cells cannot grow and is considered 
harmless, it is possible that events could occur within the cells that allow the virus to 
grow or cause the cell to become cancerous. It is also theoretically possible that a 
viral infection could set up in your body. If this should occur, it is possible that you 
could develop a malignancy. We do not expect this to happen because we monitor 
the transporter virus closely to make 
sure that no infectious virus is present. It is possible that the cells containing the 
MDR-1 gene could delay your bone marrow recovery. We believe this is unlikely 
because enoughnormal marrow will also be given back to you to allow for normal 
recovery, but we cannot be sure. The special procedure that we will use to isolate 
your stem cells before exposing them to the MDR-1 gene may leave behind a small 
amount of antibody on your cells. It is possible that this antibody could cause an 
allergic reaction. Over 50 patients have received stem cells purified using this method 
without any evidence of an allergic reaction, but you will be monitored for an allergic 
PATIENT IDENTIFICATION I CONTINUATION SHEET FOR EITHER: 
I NIH-251 4-1 (9-91) 
I NIH-251 4-2 (9-91) P. A. :09-25-0099 
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Recombinant DNA Research, Volume 18 
