CONSENT TO ACT AS A SUBJECT IN AN INVESTIGATIONAL STUDY 
UPCC 3394. June 1994 
(Revised. July 1994) 
1) Title of research project: 
Treatment of advanced CNS malignancy with recombinant adenovirus: Phase IB. 
2) Investigators: Jane B. Alavi, Abass Alavi, Stephen Eck, Joan Mollman, Kevin Judy, 
David Hackney, Peter Phillips (Telephone number of Dr. Alavi: 662-6319 or 662-6059; 
telephone number of Dr. Eck: 734-8226) 
3) Purpose: The purpose of this study is to determine the safety of a new form of 
brain cancer therapy. In this study a recombinant (laboratory -produced) 
adenovirus will be directly injected into your brain cancer. (An adenovirus is a 
common virus which often causes infections of the nose and windpipe and lungs). 
You will then receive a drug called ganciclovir. The primary purpose of this study is to 
determine if this type of treatment can be safely done in humans. The virus has been 
especially designed to carry a gene, herpes simplex thymidine kinase (HS-TK). It is 
also altered to make it difficult for it to multiply. The study will also investigate whether 
this gene ( a gene is made of DNA) will enter brain tumor cells and cause the tumor 
cells to be killed by ganciclovir. 
You have been asked to participate because you have a brain tumor which 
failed to respond to conventional therapy. 
4) Description of the project: 
1) Pre-gene therapy evaluation. You will be evaluated to determine if you are a 
suitable subject to participate in the gene therapy study. This will involve a full 
medical history and physical examination, blood tests, MRI scan of the brain and 
chest x-ray. Approximately 30 ml (2 tbs.) of blood will be taken from an arm vein. A 
pregnancy test will be performed if you are a woman with child bearing potential. 
2) Gene therapy study. You will be admitted to the Clinical Research Center or the 
Neurosurgery Service of the Hospital of the University of Pennsylvania. A positron 
emission tomography scan (PET scan) of the brain will be performed. For this scan, 
you will lie on a comfortable reclining chair in the Nuclear Medicine Section of the 
hospital, and scans (pictures) will be taken of your brain. Your head will not be 
enclosed during this procedure. Prior to the scans, a needle will be placed in the 
radial artery (at the wrist) for samples of blood. Another needle will be placed in an 
arm vein (in the hand or elbow area) and used for injection of a radioactive form of 
sugar, F-18 deoxyglucose. The purpose of the PET scan is to determine if your brain 
tumor uses sugar, as many malignant tumors do. The PET scan will be repeated at 2 
weeks and 4 weeks after gene therapy, to see if the treatment has changed the 
characteristics of the tumor. 
On the second hospital day you will be taken to the operating room. Under 
local anesthesia, a stereotactic frame will be placed on the outside of your head. 
This is a large ring attached to the scalp temporarily, to permit precise measurements 
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