UPCC 3394, June 1994 
University of Pennsylvania 
Informed Consent 
Treatment of advanced CNS malignancy with recombinant adenovirus:Phase IB 
Lumbar puncture: This can lead to pain, bruising or bleeding in the back where 
the needle is placed. 
Surgery: You will be asked to sign a separate consent form for the 
neurosurgery. The potential risks include paralysis, stroke, difficulty with speech or 
vision that may be temporary or permanent, bleeding into the brain, infection, and 
possible death. 
PET scans: The arterial and venous catheters (tubes) could cause some 
bleeding at the site of the injection. The tube could become disconnected causing 
blood loss or the artery or vein could become clotted. This could cause circulation 
problems in the hand making it cold and painful. Pieces of the tube or clot could 
break off and lodge elsewhere requiring treatment. These complications are 
extremely rare. The PET scan utilizes radioactive material and therefore you will 
receive a radiation dose. The radiation dose you receive is within the limits permitted 
by the FDA for human research volunteers. While the radioactive material is in your 
body it is not hazardous to persons near you. Also it will have largely disappeared 
within 6 hours. These studies will not be performed on pregnant women. A blood 
pregnancy test will be done on any woman of child bearing potential. 
In this research study, you will be asked to have more frequent scans and tests 
than is usual for patients undergoing brain tumor treatment. 
Complications caused by the virus. The virus that is being used has been 
made so that it cannot reproduce by itself. There is a very slight possibility that 
something may happen during the study that will allow the virus to multiply. The 
effects of this event are unknown. However your immune system will likely kill the virus 
after it has been there for several days to weeks. It is possible that the virus could 
spread from your body to your surroundings. The virus has been altered so that it can 
not reproduce by itself. If however, something should happen that the virus does 
spread and reproduce, it would likely behave no differently from similar types of 
viruses that are already in the environment around us. However, if there are signs that 
virus is being spread, you may be asked to remain in the hospital longer than 2 
weeks for further monitoring. The type of virus used in these studies is not the type that 
inserts its genes into the patient's own genes. The insertion into normal genes is 
thought to be a cause of cancer in very rare instances. Because insertion of the virus 
gene into your genes is highly unlikely, the chance that the virus will cause cancer is 
very small. There is a remote possibility that the virus could change genes in the 
body's eggs or sperm. Therefore patients who are pregnant are not permitted to 
enter this study, and all patients in this study are advised to take precautions not to 
bear children in the next few months following treatment. 
Withdrawing from the study. If you withdraw from the study after the gene is 
placed into your brain, it will not be possible to evaluate fully the safety of gene 
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