UPCC 3394, June 1994 
2 
University of Pennsylvania 
Informed Consent 
Treatment of advanced CNS malignancy with recombinant adenovirus: Phase IA 
This is a large ring attached to the scalp temporarily, to permit precise measurements 
of the tumor location. You will be transported to the MRI scanner for an MRI scan of 
the brain, then back to the operating room. General anesthesia will then be 
administered and the neurosurgeon will perform surgery by stereotactic technique. 
In other words, the brain will be entered through small holes rather than through a 
large incision in the skull. The surgeon will inject into the tumor a small amount of the 
recombinant adenovirus, containing the herpes simplex thymidine kinase (TK) gene. 
After the surgery, you will be taken to the Intensive Care Unit for routine post operative 
care. You will be transferred back to the Clinical Research Center (CRC) in 1 or 2 
days. The stereotactic frame will be removed after surgery. 
Two days after the surgery, you will begin to receive the drug ganciclovir in the 
vein, twice a day, for seven days. You will have an MRI scan of the brain on the 
second and seventh post operative days. 
Approximately 7 days after the stereotactic surgery, you will have a second 
operation. This will be a standard neurosurgical operation under general anesthesia, 
to remove as much of the brain tumor as is safe and possible. After the tumor is 
removed, the surgeon will inject another dose of the same adenovirus into the area 
of remaining tumor. After this operation you will again be treated in the Intensive 
Care Unit or the CRC, with twice a day injections of ganciclovir for 14 more days. MRI 
scans will be performed 2 and 14 days after surgery. You will be discharged from the 
hospital after 14 days, or whenever your condition is considered medically stable. 
Lumbar puncture may be performed one or two times after the injection of the 
virus, to sample spinal fluid. 
You will need long term follow up. Because gene therapy is a very new form 
of treatment, the long term effects are not known. To gain the most information and 
to provide the greatest safety, periodic evaluations will be needed. Your 
agreement to participate in this study means that you recognize the need for 
prolonged relationship with the study and appreciate the need for continued 
evaluations. This will entail monthly evaluations that include history, physical 
examination, MRI scan and routine blood tests for one year, and less frequent 
evaluations for as long as you live. 
Consent for autopsy. To fully evaluate the effects and safety of gene therapy, 
it will be necessary to obtain as much information as possible. In the eventual 
occurrence of your death, evaluation of your brain and other organs will be a very 
valuable method to see the full effects of gene therapy. Therefore your participation 
in this study means that you agree to an autopsy. This agreement must also be 
known by your next of kin so that person can follow with your wishes. 
5) Risks and discomforts of the research. 
Blood tests: You may develop a bruise or tenderness at the site of needle 
punctures. 
Recombinant DNA Research, Volume 20 
[377] 
