The University of Texas 
M.D. ANDERSON CANCER CENTER 
INFORMED CONSENT 
PROTOCOL TITLE: USE OF SAFETY-MODIFIED RETROVIRUSES TO INTRODUCE 
CHEMOTHERAPY RESISTANCE SEQUENCES INTO NORMAL 
HEMATOPOIETIC STEM CELLS FOR CHEMOPROTECTION 
DURING THE THERAPY OF OVARIAN CANCER: A PILOT 
TRIAL 
1 . 
Participant's Name 
I.D. 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 with the 
following purpose: To make normal marrow cells resistant to 
chemotherapy and reduce the complications of therapy. 
3. DESCRIPTION OF RESEARCH: In order to make normal marrow cells 
resistant to the side effects of chemotherapy, the following 
will be carried out: (A) The patient's own normal marrow and 
peripheral blood cells will be harvested from the peripheral 
blood using a pheresis machine and from the bone marrow by 
placing the needles into the hip bone during general 
anesthesia. These cells will then be made more resistant to 
chemotherapy by introducing a pumping mechanism, the MDR-1 
gene, into the cell. This results in the pumping of the 
chemotherapy drugs from the inside to the outside of each 
cell, which protects it from therapy. We will insert the 
chemotherapy pump into the marrow cells by a carrier molecule 
which is taken from a virus. This is called a safety-modified 
virus. This molecule carries the genetic information for the 
membrane pump into the marrow cells, but does not cause an 
infection. (B) Two chemotherapy drugs will be given 
(cyclophosphamide and thiotepa) to eliminate the patient's 
marrow. The modified marrow cells which carry the chemotherapy 
pump gene will then be transfused. This will be given by vein 
in a manner which is similar to any blood transfusion. The 
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