From : DEUEL GENETICS t MOLEC BIOL 
RHONE No. : 216 368 3590 
May. 28 1993 12:03PM 
CONSENT FORM ATTACHMENT G 
p2. Effect of Epi&omu- Based Antisense eDNA Transcription of Insulin-Like Growth Factor I 
on Tumorigenicity of Human 
cancer cells in animals, and these cells have been injected back into the animals. 
When this is done the genetically altered cells gradually disappear and the 
primary cancer resolves. 
If samples of the original cancer tissue from the animal with cancer are looked at. 
as the cancer is disappearing, a strong immune reaction is found. Thus the 
animal's body is actively rejecting the tumor. The main cells which appear to be 
causing this rejection are called T lymphocytes. The T lymphocytes attack and 
destroy the glioblastoma cancer cells with the anti-sense vectors in them, and also 
attack and destroy the main glioblastoma tumor. If a different, unrelated, tumor 
is also present in the same animal, the T lymphocytes do not attack it. Why the 
animal's immune system is turned on in a strong fashion to attack and destroy the 
cancer cells is not known. 
Although these results are very encouraging, it is not at all certain that the 
studies in animals will translate into treatments in human beings. The purpose of 
this study is to gain information about whether or not this new approach will be 
effective in treating human brain tumors. I will be one of the first people to 
receive this experimental treatment for brain tumors. While it is hoped that 
information on the usefulness of this approach in humans, will be gained, it is not 
known if my tumor will get smaller as a result of this treatment. 
The usual treatment for my brain cancer, which prescribed by my personal 
Neurosurgeon, will be exactly the same whether or not I participate in this study. 
The additional research procedures are described next. 
At the time of surgery done to remove as much of the brain cancer as 
possible, or at the time of biopsy to confirm the characteristics of my tumor, a 
small sample of cancer cells (less than the size of a pencil eraser) will be obtained 
and these cells will be examined by the pathologist and will be cultured under 
sterile conditions in the laboratory. If my tumor is a glioblastoma multiforme, 
and expresses IGF-I, I will be eligible to continue in the study. An additional 
requirement that I agree to follow before entry into this study is lhat I will use 
contraception measures advised by my doctor, and if I am of child-bearing age 
and female, 1. will obtain a pregnancy test to be certain that I am not pregnant 
before any treatment is begun. 
At a predetermined time an attempt would then be made to alter the genetic 
material of my brain tumor cells growing in the laboratory. A vector which 
carries the gene that produces anti-sense RNA to insulin-like growth factor-I 
n501 Recombinant DNA Research, Volume 18 
