The University of Texas 
M.D. ANDERSON CANCER CENTER 
Informed Consent 
INFORMED CONSENT 
PROTOCOL TITLE: USE OF MODIFIED RETROVIRUSES TO INTRODUCE 
CHEMOTHERAPY RESISTANCE SEQUENCES INTO NORMAL 
HEMATOPOIETIC CELLS FOR CHEMOPROTECTION DURING 
THE THERAPY OF BREAST CANCER: A PILOT TRIAL 
1 . 
Participant’s Name LD. Number 
You have the right to know about the procedures that are to be used in your participation in 
clinical research so as to afford you an opportunity to make the decision whether or not to 
undergo the procedure after knowing the risks and hazards involved. This disclosure is not 
meant to frighten or alarm you; it is simply an effort to make you better informed so you may 
give or withhold your consent to participate in clinical research. This informed consent does not 
supersede other informed consents you may have signed in other protocols. 
DESCRIPTION OF RESEARCH 
2. PURPOSE OF STUDY: This is a clinical research study to test whether normal 
peripheral blood stem cells can be made resistant to chemotherapy and thereby reduce 
the complications of chemotherapy. 
3. DESCRIPTION OF RESEARCH: (A) Patients who agree to participate in this study will 
first receive cyclophosphamide chemotherapy, which may reduce the amount of breast 
cancer in the body, and at the same time prepare such patients for collection of the 
peripheral blood cells. Then, 250 cc (8 oz) of the blood will be withdrawn and run 
through a pheresis machine, which will separate peripheral blood cells from the plasma, 
which wiU be returned. To obtain bone marrow cells, general anesthesia will be given 
and cells will be extracted through needles which are placed in the hip bone. 
(B) The peripheral blood cells will then be made more resistant to chemotherapy by 
introducing a gene for multi-drug resistance (called MDR-1) into the cells. The MDR-1 
gene will be inserted into the cells by a virus which has been modified so that it should 
not cause an infection. This will be done by incubating the stem cells in the presence 
of the virus that carries the MDR-1 gene. Patients for whom the bone marrow or 
peripheral blood cell harvest is inadequate, or whose cells are not modified by the MDR- 
1 gene at an adequate rate, will not be eligible for transplant. 
(C) Three chemotherapy drugs will be given (cyclophosphamide, BCNU, and thiotepa) 
to eliminate bone marrow, and to reduce the level of cancer in the body. This 
chemotherapy may also significantly reduce the amount of breast cancer in the body. 
The modified marrow cells which carry the MDR-1 gene will then be given by vein in 
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