MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
Nl H 2514-1, Consent to Partici pate in A Cli nical Research Study 
NIH 251 4-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER Continuation: paoe 3 of pages 
called growth factors that help the blood cells divide and with a retroviral vector that 
carries the MDR-1 gene. Vectors are organisms that carry material from one cell to 
another. Our vector is a retrovirus found in mice which has been ‘disabled’ to make 
the virus incapable of replicating. The vector enters the blood cells and puts the 
MDR-1 gene into the genetic material called chromosomes. Once in the 
chromosomes, the MDR-1 gene will survive as long as the cell survives. The MDR-1 
gene makes the blood cells resistant to drugs and “marks” them so we can identify 
them. The blood cells, vector and three growth factors are put together in a mixture 
called a culture. After 3-6 days, the cells are removed from the culture and “washed” to 
remove any extra virus or growth factor attached to them. The “marked” cells are then 
frozen and are returned to you at the time of transplantation along with the 70% of your 
bone marrow and blood cells that have not been exposed to the vector. The untreated 
cells should be enough to produce blood count recovery in the expected time period 
after high dose chemotherapy. 
The standard blood drawings and tests that are required following bone marrow 
transplantation will be performed. These have all been explained to you in a separate 
consent document. During your hospitalization and after you are discharged, blood 
samples will be drawn to study your blood counts and to determine whether the 
MDR-1 gene is present in the blood cells. Approximately two extra teaspoons of blood 
will be drawn three times a week for these research studies. Bone marrow aspirations 
will be obtained at 2, 4, and 6 weeks after your bone marrow is given back to you to 
test for the presence of the MDR-1 gene. You will be given local anesthesia for these 
bone marrow aspirations. The side effects of the biopsies include pain, bleeding and 
infection. The bone marrow aspirations are scheduled as part of the transplantation 
protocol to keep track of your bone marrow recovery. No extra bone marrow 
aspirations will be done because of the gene marking protocol while you are 
hospitalized, but an extra one teaspoon of marrow will be taken during the exam to test 
for the MDR-1 . You will be asked to return monthly to NCI for evaluation after you are 
discharged from the hospital. Four extra teaspoons of blood will be drawn from you 
each month and a bone marrow aspiration will be obtained every three months to 
determine whether your bone marrow cells contain the MDR-1 gene. After six months 
you will return to NCI every two months at which time 4 teaspoons of blood and a bone 
marrow biopsy will be obtained if your bone marrow cells contain the MDR-1 gene. 
No further bone marrow biopsies will be obtained if the MDR-1 gene cannot be found 
on two successive bone marrow biopsies after you are discharged. We request that 
you return periodically to the NCI for the rest of your life so that we may follow you for 
any side effectsthat may occur. Should you die, for any cause, we will request that an 
autopsy be performed to study whether the MDR-1 gene is present in your body. 
You will be asked to undergo a biopsy of your tumor prior to bone marrow 
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 
[295] 
