MEDICAL 
RECORD 
eONIIMUATION SHLUKor either: 
Nl H 2514-1, Consent to Partici pate i n A Cl i ni cal Research Study 
NIH 251 4-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER 
Continuation: page 2 of pages 
administration of chemotherapy should you need further treatment after bone marrow 
transplantation. 
We will use a new technology, “retroviral mediated gene transfer,” in an attempt 
to put a human gene called MDR-1 into some of your bone marrow and circulating 
blood cells before they are transplanted back into your body. Then we will test bone 
marrow and circulating blood cells periodically to see whether the MDR-1 gene is in 
the cells and how long the gene stays there. The MDR-1 (multidrug resistance) gene 
helps cells to become resistant to certain chemotherapy drugs including doxorubicin, 
taxol, and vinblastine. We hope that a portion of your bone marrow and peripheral 
blood cells will contain the MDR-1 gene after your transplant. Should your breast 
cancer recur, we will offer you treatment with the chemotherapy drugs taxol or 
vinblastine. The ultimate hope is that the MDR-1 gene will protect your bone marrow 
from the toxic effects of chemotherapy although this mav not occur during these early 
stages of development of this treatment approach . It is important to understand that 
the introduction of this gene may not benefit you in any way. It is possible that this 
study may lead to improved bone marrow transplantation therapies for others in the 
future. It is possible that the MDR-1 gene may protect a portion of your bone marrow 
from the toxic effects of future chemotherapy, but we do not know whether this will 
occur at this time. 
EVALUATION AND PROCEDURES 
The following procedure will be used to insert the gene into your bone marrow 
and blood cells. Your bone marrow cells will be obtained by bone marrow harvest in 
the operating room using the regular procedure for harvest. It will not be necessary to 
take any more bone marrow than is normally taken. Your circulating stem cells will be 
obtained by removing blood through a vein, separating the immature “stem” cells of 
interest, and returning the remaining blood to you through a vein. No more than 30% 
of marrow and blood stem cells will undergo retroviral-mediated gene transfer and the 
rest will be handled in the usual fashion. In this 30% portion, the cells to undergo the 
gene transfer will be separated from the other bone marrow and blood cells by 
attaching a special antibody to them and then physically removing only the cells that 
can pick up the antibody. This procedure is called “immunoadsorption” and it allows 
us to separate the most immature stem cells which will be the ones used for the gene 
transfer. The laboratory machine (called an immunoadsoprtion column) used in this 
protocol is experimental. Once the immature blood cells have been separated, the 
antibody will be removed. These cells will then be mixed together with two substances 
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 
I 
[294] 
Recombinant DNA Research, Volume 18 
