DUKE UNIVERSITY MEDICAL CENTER 
A PHASE I TRIAL OF HUMAN GAMMA 
INTERFERON TRANSDUCED AUTOLOGOUS 
TUMOR CELLS in PATIENTS with 
DISSEMINATED MALIGNANT MELANOMA 
(Page 1 of 5 ) 
IRB# 1456 92-12 
Your doctor has explained to you that you have advanced malignant 
melanoma which cannot be cured by currently available standard 
treatments (surgery, chemotherapy, hormonal therapy or radiation 
therapy) . You are being asked to participate in a research study 
which was designed to test the safety and effectiveness of an 
investigational treatment for melanoma. 
This treatment utilizes an experimental substance which is produced 
at Duke University Medical Center and at Viagene Corporation. The 
treatment is prepared by surgically removing one of the metastatic 
melanoma's from your body and processing this tumor in the lab in 
a test tube. The tumor cells in the test tube will be altered or 
changed by inserting a gene (genetic material) which causes the 
tumor cells to make a protein called gamma Interferon ( 7 -IFN) . 
These cells are called gamma interferon transduced autologous tumor 
cells . 
This gene is inserted into your tumor cells by an altered virus 
(vector) which does not grow but is intended to act as a vehicle to 
transfer the gene into the tumor cells. Once the virus gets the 
gene into the tumor cells, these cells will hopefully produce gamma 
Interferon and will be made into a treatment solution to be given 
to you by injection. 
This research study is designed to determine whether this solution 
is safe and can perhaps stimulate your body to reject your 
melanoma . 
If you chose to enter this program, you will be given a vaccination 
underneath the skin (subcutaneously) of your body every two weeks 
for three months and monthly thereafter until you receive twenty- 
four (24) total treatments. This will require twenty-one (21) 
months. 
Patients Initials 
Recombinant DNA Research, Volume 17 
[649] 
