MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
NIH 25 M-1 , Consent to Participate in A Clinical Research Study 
NIH 25 1 4-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER: 
CONTINUATION: page _4_ of _j6__ page: 
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 neo^ - 
gene in the tumor cells. The risks from this biopsy include pain, bleeding, infection or a 
punctured lung. 
After the bone marrow transplantation you may be asked to undergo a process called 
■p 
apheresis to obtain blood cells to study whether the neo— gene is inside them. During apheresis, 
blood is withdrawn via a needle placed in one aim, and channeled into a cell separator machine. 
The machine separates the white cells from the remaining blood elements. Your red cells and 
the rest of your blood will be returned to you through a needle placed in your other arm. 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blood, since most of what is withdrawn is put back.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, 
D 
depending on how long the neo^ - gene remains in your cells. 
RISKS AND TOXICmES 
No side effects from the neo^ marker gene and the transporter virus to be used in this 
protocol have been seen in animal studies or in the very limited human studies on gene transft 
which began in May, 1989. 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 you could become infected with the 
virus. Since this has never happened, the consequences of such an infection are unknown. It is 
possible that the bone marrow cells containing the neo^ gene could delay your bone marrow 
recovery. We believe this is unlikely because enough normal marrow will also be given back to 
you to allow for normal recovery, but we cannot be sure. Also, the inserted gene produces a 
substance that inactivates the antibiotics neomycin and amikacin. These antibiotics are rarely 
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 
[137] 
