MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1 , Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER: 
CONTINUATION: page 
of page: 
used during bone marrow transplantation or other medical care. The antibiotics routinely used 
are not inactivated, and these will be given to you to treat any bacterial infections that might 
occur. 
It is possible that breast cancer cells that may be present in small numbers in your bone 
marrow may also be infected with the neo^ - gene. We will study whether this is the case by 
biopsying your tumor should it come back after bone marrow transplant We do not believe that 
D 
you would be harmed should a breast cancer cell in the bone marrow receive this neo^ gene; 
however, little information exists about this. It is possible that the neo^ - gene could alter the 
breast cancer cell making it more or less malignant We believe this is unlikely, but can’t be 
sure. It is also possible that the growth factors used to put the neo^ gene into the bone marrow 
cells could cause breast cancer cells to grow. We believe that these possibilities are unlikely to 
cause you any harm if they did happen, but we can’t be sure. There is also a small possibility 
that you could have an allergic reaction to the “marked” cells with the neo^ gene due to residual 
antibody that could be attached from the immunoadsorption column on residual growth factors 
that could be attached from the culture. We think it is unlikely that any small amount of 
antibody or growth factor attached to the cells would cause you any harm, including an allergic 
reaction, but it is theoretically possible. Should an allergic reaction occur, the physician present 
while you_are receiving the cells will treat you for the reaction. 
Participation in this study is entirely voluntary. You may choose to participate or you 
may withdraw from the gene transfer study at any time up to the time of infusion of the bone 
marrow. Enough bone marrow has been harvested to be able to proceed with the transplantation 
even without the cells that are treated with the necA ^ gene. If you withdraw your consent, the 
gene-marked cells will not be infused. In the event that you do withdraw your consent after 
harvest, but do go ahead with transplantation, the course of your disease will be followed on a 
regular basis at NIH. You are encouraged to ask any questions that you may have and to take as 
much time as you need to make your decision. 
The costs of hospitalization, treatment, and laboratory procedures related to the bone marrow 
transplantation that are provided at NIH are also paid for by NIH. It is important to understand 
that NIH cannot pay for tests or medical care that you receive outside of NIH. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-25 14-1 (10-84) 
NIH-251 4-2 (10-84) P.A.: 09-25-0099 
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Recombinant DNA Research, Volume 16 
