P.19 
PUG 29 '94 13:52 VUMC CELL BIOLOGY 
CONSENT FOR RESEARCH STUDY 
ADULT: (Patient) [X] 
PRINCIPAL INVESTIGATOR: Jeffrey Holt MD 
TITLE OF PROPOSAL: Antisense Retrovirus Gene Therapy for Metastatic 
Breast Cancer 
NAME OF RESEARCH VOLUNTEER: 
AGE: 
TO PERSONS WHO AGREE TO PARTICIPATE IN THIS STUDY: 
The following information is provided to inform you about the research project and 
your participation in it. Please read this form carefully. Any questions you may have about 
this study will be answered. Please feel free to ask any questions you may have about this 
study and/or about the information given below. Written form [X] Oral form [ ) 
ITEM #1: Indicated below are the following: 
(a) The purpose of this study 
(b) The procedures to be followed 
(c) The approximate duration of this study 
Your breast cancer is metastatic-that is, cancer cells have spread into your lungs, 
abdomen, or brain. When breast cancer has spread to this extent and does not respond to 
chemotherapy, no other treatment has yet been shown to work. 
Using knowledge gained from the study of genetics, we have developed an experimental 
method to treat metastatic breast cancer using "gene therapy.” We have tested our method in 
the laboratory and have found that it will shrink breast cancers in mice. We are now asking if 
you are willing to be one of the first subjects in a study whether our new method will have 
any effect on metastatic breast cancer in human beings. While we hope to gain information on 
the usefulness of this method, we cannot guarantee your tumors will shrink as a result of this 
experiment. 
What is gene therapy for breast cancer ? 
We will attempt to change the genetic material (DNA) of your breast cancer cells by 
inserting into these cells what is known as an "antisense” gene. This gene will be carried into 
the cells in a "vector" the same way a passenger is carried into a parking garage in a car. The 
vector (or car) in this case is a genetically modified virus. In its original form, this virus 
causes breast cancer in mice. We have kept those parts of the virus which make it infect breast 
cells while removing those parts that cause cancer. In the place of that DNA we have put the 
antisense gene (like the passenger in the car). When the antisense gene enters the cancer cells, 
it should block their growth . In sum we have taken a virus and turned it into something that 
should attack cancer cells instead of causing cancer. 
Recombinant DNA Research, Volume 20 
[181] 
