Raoul Salup, M.D. 
Assistant Chief of Urology 
VA Hospital 
University Drive C 
Pittsburgh, PA 15240 
(412) 692-3552 
Maury Rosenstein, M.D. 
Department of Radiation Oncology 
University of Pittsburgh Medical Center 
(412) 647-3600 
SOURCE OF SUPPORT : None 
INTRODUCTION AND BRIEF DESCRIPTION : I have been invited to participate in a study to see if I can benefit 
from being injected with a preparation made from my own skin. I am aware that my tumor has spread beyond the 
limits that are curable by surgery or other standard treatments. While it is not possible to predict whether I will 
receive any personal benefit from my participation in this study, information may be obtained that will be helpful to 
others with similar disease. To be eligible for this protocol, I certify that I am not pregnant or planing to get 
pregnant In addition , I will use barrier forms of contraception during the treatment. 
Before beginning treatment, my physician will perform a history and physical examination. Routine physical 
examination will include evaluation of the heart, lung, abdomen, head and neck and extremities. This will also 
include measurement of all skin lesions. I will have blood tests (approximately 4 tablespoons of blood will be 
drawn), a urine test a chest x-ray, an electrocardiogram to check my heart, and CT or MRI scans (special x-rays) 
performed. Blood (4 tablespoons) will be drawn on days 0 (pre-treatment), 7, 14, 21, 28, 35 and 42. These blood 
tests are to look at cells in my blood called lymphocytes and the level of EL- 12 in my blood. Skin tests will be done 
to determine how my immune system is working. The Merieux (Pasteur-Merieux) skin test is commercially 
available from the pharmacy and is routinely used on patients to determine if their immune system reacts to the skin 
test. I will also be given a small injection of my tumor cells that have been irradiated to determine if my immune 
system reacts to my tumor cells. 
I understand that in order to perform this study, fibroblasts will be prepared. These are cells that are normally found 
in the skin. In order to obtain these cells, a small piece of my skin (1/2 inch wide and 2 inches long) will be 
removed. Little discomfort will be associated with the skin removal. The area will be injected with a medication to 
numb the area and then the skin will be surgically removed. A few stitches may be used to close the area. A clean 
dressing will be applied. I will be monitored closely and treated for any problems that may occur. This will be done 
at the time when my doctors are getting tissue samples for the diagnosis of my tumor. When enough of these cells 
have been obtained, my doctors will take a mouse virus, which contains a human gene (interleukin-12), and then 
insert these into the fibroblast cells from the skin. This virus has been developed in the laboratory to contain the 
human gene which can alter immune reaction of the human body. The mouse virus appears to be applicable to 
human, this is based on current information that could change in the future. This will be used as a "transportation 
system", and will also contain a substance which can be recognized by special testing. This new gene will enable 
my fibroblast skin cells to make a normal human protein called interleukin- 12 (IL-12). IL-12 is usually made in 
very small amounts only by cells of my immune system. Interleukin- 12 is thought to stimulate an immune 
response to the tumor cells in the preparation. This immune response may make my tumors shrink. 
Approximately 3-4 weeks after the skin biopsy has been done, the fibroblasts that are making interleukin- 12 will be 
injected into one or two of my tumors that are easily accessible, such as those lying in the skin using a very small 
needle. These sites will be tattooed (very tiny marking) with a substance called india ink so that their location will 
be known. Each site will contain fibroblasts that are either making or not making interleukin- 12. I understand that 
I must return to the Pittsburgh Cancer Institute Outpatient Services the next day after these injections for the 
puipose of seeing if I am having any side effects. 
Recombinant DNA Research, Volume 19 
Patient'Sj.gg^s 
