CONSENT FORM 
p3. Effect of Epi some -Based Antisense cDNA Transcription of Jnsulin-Like Growth Factor I 
on Tumorigenicity of Human 
(IGF-I) would be inserted into the growing tumor cells. The vector consists of 
parts of a virus which can divide and make multiple copies of itself once it is 
inside of the cancer cells. The virus has been made inactive as an agent which can 
cause infection by taking away parts, so it cannot make whole new viral particles 
inside the cell. However the vector will make multiple copies of the anti-sense 
RNA that blocks the formation of insulin-like growth factor-I. 
What will my participation In these experiments involve? 
Once my brain tumor cells have been genetically altered in the laboratory, 
they will be injected back under the skin of one of my arms using a 
needle and syringe. Like any immunization or "shot” this procedure will be done 
while I am awake. An injection under the skin is a simple procedure usually done 
on outpatients. However, since the injection of genetically altered tumor cells into 
humans has not been done before, I will be hospitalized for close observation. All 
told, 1 will receive a total of 3 or 4 injections spaced 4 weeks apart. 
I will be kepi in the hospital for 24 hours to check for an allergic reaction, 
such as local redness, or if more severe, flushing of the skin or wheezing. My 
doctors do not expect such a reaction since I will be receiving my own cells back. 
However, if I should develop such a reaction I would receive medications such as 
antihistamines while in the hospital. Another possible complication of injecting 
back my tumor cells could be introducing an infection under my skin. This 
complication is unlikely because the cells are grown under sterile conditions and 
tested to insure that lliey are free of bacteria or virus before they are injected 
back under my skin. However I will be monitored closely for development of 
infection by checking my temperature and by obtaining complete blood counts 
three times per week during the first week and once a week thereafter. Should an 
infection occur, appropriate antibiotic therapy will be started. 
1 will need to come back to see the research doctors three limes in the first 
week for physical and neurologic examination and blood testing. 1 will come 
back weekly for four weeks, and every two weeks for four months, then monthly 
thereafter for at least one year. I will continue to be followed at less frequent 
intervals for life. My doctors will check me closely to make sure I have not 
developed any complication. They will examine my arm for signs of infection or 
evidence of a reaction. A skin biopsy of the injection site will be made three 
months after the genetically altered tumor cells are injected under my skin. 
Recombinant DNA Research, Volume 18 
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