AUG 29 ' 94 13:54 VUMC CELL BIOLOGY 
PRINCIPAL INVESTIGATOR: Jeffrey Holt MD 
TITLE OF PROPOSAL: Antisense Retrovirus Gene Therapy for Metastatic 
Breast Cancer 
p .22 
Page 4 
ITEM #4: The possible benefits to you from this study are: 
Your cancer may shrink as a result of the infusion of viral antisense vector 
into tumor cells, control symptoms, and/or prolong your survival. However, we cannot 
guarantee any of these at this time. 
ITEM #5: The benefits to sciences and to mankind that are sought by this study are: 
Gene therapy is a new and emerging technology which many hope will become a 
powerful mode of treatment in the future. This study is designed to develop 
effective means of delivering genes into cancer cells, to learn how to improve the 
delivery of vims vectors into human cancer cells, and hopefully to specifically 
inhibit tumor cells from growing and., spreading. 
ITEM #6: (a) Alternate procedures that might be advantageous, but which will not be used 
are: 
No alternative forms of treatment are known to be advantageous for patients in 
your situation. If you decline to participate in this study, you would of course receive standard 
medical care aimed at making you comfortable and providing whatever other benefits are 
possible with present methods. 
(b) The reasons for not using them are: 
We could not do the study. 
ITEM #7: Your rights of privacy will be maintained in the following maimer: 
(1) All data obtained on you during the course of this study will be kept 
confidential and will be accessible only to the principal investigator and his/her assistants on 
this project: except as stated elsewhere. 
(2) Should the results of this project be published, you will be referred to only by 
number. 
NOTE: YOU ARE FREE TO WITHDRAW THIS CONSENT AND TO DISCONTINUE 
PARTICIPATION IN THIS STUDY OR ACTIVITY AT ANY TIME 
If you choose to withdraw after removal of fluid but before the injection of the vector 
then you might suffer from dehydration (loss of body fluid). Withdrawal at 
other times would have no special risks. 
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Recombinant DNA Research, Volume 20 
