PHASE I TRIAL OF AdR SVtk VIRUS WITH GANCICLOVIR IN 
PATIENTS WITH UNRESECTABLE MALIGNANT 
MESOTHELIOMA 
UPCC 2594 
Principal Investigator-Joseph Treat, M.D. 
Co-Investigator-Steven Albelda, M.D. 
University of Pennsylvania Cancer Center Clinical Trial 
Emergency Telephone 215-662-6059 
Office Telephone 215-662-7711 
CONSENT TO ACT AS A SUBJECT IN AN INVESTIGATIONAL STUDY 
PURPOSE 
I understand that my diagnosis is mesothelioma, a cancer, which can not be surgically removed. 
There is no standard therapy for this condition. The purpose of this study is to determine if an 
experimental type of therapy called "gene therapy" can be useful in the treatment in 
this type of cancer. 
Gene therapy is a new type of cancer therapy. It involves inserting a specially designed “gene” into 
cancer cells. Once inside the cancer cell, this gene becomes the blueprint for the production of a new 
protein which can be used to help destroy the cancer. The approach to gene therapy in this trial is to 
place a "suicide" gene into a type of common-cold virus (the adenovirus) and infect the cells within your 
chest with the modified virus. Both normal and tumor cells will take up the virus. We will then give 
you a drug called ganciclovir). Ganciclovir is an approved drug that is normally used to treat viral 
infections. At the doses used in this study, it does not usually cause severe side effects. Ganciclovir 
works by killing cells that divide if they contain the virus protein. Therefore, any cell that has taken up 
the new gene and starts to divide will be killed. Since the normal cells of the chest cavity do not 
normally divide, while the tumor cells do grow rapidly, the tumor cells will be selectively killed by this 
treatment. We have conducted many experiments in animals to show that tumor cells are killed without 
damaging the normal cells in the chest. 
The major goals of this study are: L. To determine the highest dose of the genetically altered 
adenovirus experimental therapy which can be given safely with ganciclovir, the anti-antiviral drug, 'L 
To determine the side effects of this experimental therapy, _3. to see if shrinkage of tumor occurs with 
this experimental therapy. 
PROCEDURE 
Initial testing will be done. This includes a history and physical exam and blood work to check your 
blood count, kidney and liver function. CT scans will be done to document the presence of the tumor. 
Often scans may be done if required by the presence of symptoms to see if disease is present in locations 
other than the chest. 
I will be admitted to the hospital. At this time a surgical procedure called a “videothoroscopy” will 
be performed (see next paragraph for details). This is placement of a flexible metal scope through the 
side of the chest into the cavity between the lung and the inner chest wall and will allow us to document 
the presence of the mesothelioma and to place a chest tube. A chest tube is a flexible plastic tube. The 
chest tube will be used to administer the gene therapy virus on the second day. I will remain in the 
hospital for a total of approximately 21 days. During this time, I will have about three chest x-rays eveiy 
week and blood work frequently ( 3 times per week). I will be tested to see if any virus can be found in 
my nose, sputum, blood, urine, or stools. I will undergo a second videothoroscopy on day five. This 
videothoroscopy will be done to see the effects of the virus upon the tumor and the chest wall. 
Ganciclovir will start on day six. It will be given twice a day through a needle in the vein for 14 days. 
Recombinant DNA Research, Volume 20 
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