P.21 
PUG 29 '94 13:53 VUMC CELL BIOLOGY 
PRINCIPAL INVESTIGATOR: Jeffrey Holt MD Page 3 
TITLE OF PROPOSAL: Antisense Retrovirus Gene Therapy for Metastatic 
Breast Cancer 
Because this is a new experimental treatment, you will not be charged for any of the 
costs of this study. Specifically, you will not be charged for hospitalization in the Clinical 
Research Center, fluid removal or infusion of the retroviral vectors, testing on fluid, or 
testing on blood. 
You can stop participating in this study at any time. 
ITEM #2: The parts of this study that are being done solely for this study are: 
The entire study. 
ITEM #3: The discomforts, inconveniences, and/or risks that can reasonably be expected are: 
Because the first four days of the study will take place in the Clinical Research Center, 
you will have the inconvenience of being confined to your hospital room for this period. 
There may be some discomfort from the daily blood drawing, with the possibility that a 
bruise could develop at the site where blood is drawn. The placement of a needle or catheter 
into your body (to remove fluid and then infuse vector/gene combinations) may cause some 
discomfort, with the possibility that bleeding or infection could occur at this site. It is possible 
that you may have an allergic reaction to the infusion, although this should be a rare 
complication since no animal serum is used to prepare the vector for infusion. It is also 
possible that the retroviral vector will kill many of the tumor cells (tumor ceil death is called 
necrosis) which could produce a strong local tissue reaction and could produce changes 
throughout your body and blood which are similar to those which result from some forms of 
chemotherapy. The removal or infusion of fluid could affect your heart and may lead to heart 
failure in rare instances. 
Risk of retroviral gene therapy: 
Although the retroviral vectors employed in this trial are unable to reproduce or 
replicate, unknown or uncommon side effects may occur since they are a new untested form 
of cancer treatment. Your doctor will follow you closely to see if any side effects are indeed 
occurring. Routine blood tests will be done to monitor the effects of treatment. 
NOTE: Immediate necessary care will be provided without charge by Vanderbilt University 
if you are injured because of participation in this research project. However, there 
is no provision for the costs of further medical care or for monetary compensation 
for such injury. 
Recombinant DNA Research, Volume 20 
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