PHASE I TRIAL OF AdRS Vtk VIRUS WITH GANCICLOVIR IN 
PATIENTS WITH UNRESECTABLE MALIGNANT 
MESOTHELIOMA 
UPCC 2594 
The ganciclovir is administered over one hour twice a day. Ganciclovir, which is approved by the 
Federal Drug Administration for antiviral therapy, will be administered in the same dose and length of 
time (14 days) as is usually recommended. 
Mesothelioma is a cancer which is found on the lining of the lung (the pleura), the inner chest wall, 
and the space between the two. To treat the tumor, a thoracic surgeon will perform a videothoroscopy 
and chest tube placement. The videothoroscopy is a surgical procedure which involves either local or 
general anesthesia and a small incision about one inch into the chest. The scope has a camera in it and 
will allow us to get a visual and photographic (video) record of the mesothelioma before the biopsies are 
taken. This will allow us to determine if the gene therapy has any effects on the size of the tumor. It will 
also allow us to take pieces (biopsies) of the tumor. Finally, a chest tube will be placed. This will allow 
for the genetically altered virus to be placed through the tube into the space between the lung lining 
(pleura) and the inner chest wall (ribs, muscle). 
After discharge from the hospital, I will be seen weekly for the First month, every two weeks for the 
second month, and then monthly. Blood tests and chest x-ray will be obtained each time. A CT scan 
will be obtained every three months. 
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. My 
agreement to participate in the study means that I recognize the need for continued evaluations. 
Specifically, on a monthly basis I will be examined and blood work to measure blood counts, liver 
and kidney function will be performed. CT scans and chest x-rays will not be done on a schedule but 
instead will be done if the clinical situation requires an x-ray test 
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 my death, evaluation of my lungs and other 
organs will be a very valuable method to see the full effects of gene therapy. Therefore my participation 
in this study means that I agree to an autopsy. This agreement must also be known by my next of kin so 
that person can carry out my wishes. 
RISKS, DISCOMFORTS AND INCONVENIENCES OF THE RESEARCH 
Blood Tests 
During the entire three month period of the study, less than one unit (one Pint) of blood will be 
drawn for tests. Also, I will have monthly blood work performed after I leave the hospital. This will 
involve one or two tablespoons of blood. I may develop a bruise or bump at the site of the needle 
puncture. Sometimes subjects get light-headed, and on rare occasions, faint when blood is drawn. 
Videothoroscopy and Chest Tube Placement 
I will undergo two videothoroscopies. The first one is to confirm the diagnosis and to place the 
chest tube. The second videothoroscopy is being done only for the purpose of answering research 
questions. 
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