MOL .EC BIOL 
PHONE No. : 
May. 23 1933 13:02PM P02 
! DEUE! GENET I L l- i 
2 1 6 
368 3590 
45 
UNIVERSITY HOSPITALS Or CLEVELAND 
patient consent for investigational studies 
TITLE OF PROJECT: 
Effect of Epitome-Based Antisense cDNA Transcription of 
Insulin-Like Oi owLh Factor I on Tumorigenicitv of Human Brain rumor. 
Attachment G 
DESCRIPTION OF STUDIES: 
I am being invited to take part in a research study that concerns the 
treatment of malignant brain cancers. My participation in the study is entirely 
voluntary. I am aware that I may not benefit directly from taking part in the 
Study. However knowledge may be gained that will benefit future patients with 
brain tumor. At any time 1 may withdraw from the study without changing my 
usual health care and without penalty or loss of benefits to which I might 
otherwise be entitled. The nature of the study, the risks,. inconveniences, 
discomforts and other information have been discussed with me. 1 have been 
encouraged to discuss any questions 1 might have about this study with the staff 
members who explained it to me. 
There is currently no cure for malignant brain tumors which have been 
classified as glioblastoma multiforme. Treatment including surgery, radiation 
therapy and/or chemotherapy cannot prevent recurrence of tumor. However, if I 
choose not to participate in this study my doctors will make available and discuss 
with me alternative forms of treatment including surgery and radiation or 
surgery alone, chemotherapy or no treatment at all. 
A new experimental approach for treatment of these tumors that takes 
advantage of knowledge gained in gene therapy research has been developed. An 
excessive production of a protein, an "insulin like growth factor” called 1GF-1, 
has been found in a number of different cancers. These include brain cancers 
such as the one I have. Why die cancer makes an excessive amount of this growth 
factor and what its specific role is in the cancer process are not yet fully known. 
The understanding of molecular biology has been used to design a vector 
which would change how cancer cells make this growth factor. A vector is in 
ways similar to a taxi cab, a vehicle which transports passengers to specific sites. 
In this case the vehicle is used to transport new genetic information into living 
cells. Genetic information is carried within the deoxyribonucleic acid (DNA) of 
cells or viruses. The DNA is the master computer which directs and controls the 
synthesis of molecules (RNA), that normally act as templates for production of 
proteins and other components essential to cell or virus structure and function. 
The taxi is itself composed of a very small portion of virus DNA that has been 
genetically altered to make it harmless to humans. The passenger is DNA that 
directs the synthesis of RNA molecules (antisense RNA) that are not normally 
produced in the cell and that interefere with the usual RNA needed to produce the 
growth factor, IGF-I. When this happens, the cell stops being able to make new 
IGF-I. This vehicle and its passenger have been introduced into glioblastoma 
Recombinant DNA Research, Volume 18 [149] 
