MEDICAL 
RECORD 
T'ONTI MUATION SHEET for either 
Nl H 25 1 4- 1 , Consent to Partici pate in A Cli nical Research Study 
Nl H 2514-2, Minor Patient’s Assent to Partici pate i n A Cli nical 
Research Study 
STUDY NUMBER Continuation: page 5 of pages 
reaction when you receive your cells back, and if one occurs, your physician will treat 
you for it. 
It is possible that breast cancer cells that may be present in small numbers in 
your bone marrow or blood cells may also be infected with the MDR-1 gene. We will 
study whether this is the case by biopsying your tumor should it come back after 
transplant. We do not believe that you would be harmed should a breast cancer cell 
receive this MDR-1 gene; however, little information exists about this. It is possible that 
the MDR-1 gene could alter the breast cancer cell making it more or less malignant or 
more resistant to drugs such as vinblastine, taxol and doxorubicin. Should this 
happen, there are drugs to treat breast cancer that are not affected by the MDR-1 
gene. It is also possible that the growth factors used to put the MDR-1 gene into the 
bone marrow or blood 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. 
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 MDR-1 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. 
All contact with the media will be coordinated through the National Cancer 
Institute’s Office of Cancer Communications. We ask you to refer any journalists or 
other media personnel to Dr. O’Shaughnessy should you be contacted. 
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 
Recombinant DNA Research, Volume 18 
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