DUKE UNIVERSITY MEDICAL CENTER 
A PHASE I TRIAL OF HUMAN GAMMA 
INTERFERON TRANSDUCED AUTOLOGOUS 
TUMOR CELLS in PATIENTS with 
DISSEMINATED MALIGNANT MELANOMA 
(Page 3 of 5 ) 
IRB# 1456 92-12 
There is no guarantee that this treatment will have any beneficial 
effects against your tumor. 
There is a 50/50 chance that your surgically removed tumor cells 
will grow in culture in the test tube and incorporate the gene from 
the virus. Only if such incorporation into cells and production of 
the Interferon substance occurs can a suitable injection liquid be 
prepared and the treatment program take place. If incorporation of 
the virus and gene into your tumor does not occur, you will not be 
able to continue with the study. 
POTENTIAL BENEFITS: There may be no benefit to you, but it is 
hoped that the knowledge gained from the experiment may help other 
patients in the future. 
FOR WOMEN OF CHILDBEARING POTENTIAL: Since this research may have 
an adverse reaction on an unborn child and should therefore not be 
done during pregnancy, it is necessary that a pregnancy test (using 
two teaspoonfuls of blood drawn from a vein by needle stick) be 
done first. You will be asked to take contraceptive measures while 
you are participating in this study. 
FOR MEN WITH POTENTIAL TO FATHER CHILDREN: It is not yet 
determined whether this treatment can adversely affect the sperm 
development in men and thus have an adverse effect on an unborn 
child. Therefore, men who are sexually active should take 
appropriate contraceptive measures for the duration of this 
research. 
ALTERNATIVE TREATMENTS: Alternative treatments for your disease 
include chemotherapy drugs, standard or investigational or other 
more investigational therapies. At any time you may choose to 
receive only supportive care with symptomatic treatment for relief 
of your discomforts. 
Patients initials 
Recombinant DNA Research, Volume 17 
[651] 
