Medical Record : Consent to Participate in a Research Study 
Iowa Methodist Medical Center 
Study Number: 
Principal Investigator: Kenneth Culver, M.D. 
CONSENT TO PARTICIPATE IN A RESEARCH STUDY: GENE THERAPY FOR THE 
TREATMENT OF MALIGNANT BRAIN TUMORS WITH IN VIVO TUMOR TRANSDUCTION 
WITH THE HERPES SIMPLEX THYMIDINE KINASE GENE/GANCICLOVIR SYSTEM 
FEDERAL REGULATIONS REQUIRE WRITTEN INFORMED CONSENT FROM 
PARTICIPANTS PRIOR TO PARTICIPATION IN A RESEARCH STUDY SO THAT THEY CAN 
KNOW THE NATURE AND RISKS OF PARTICIPATION AND DECIDE TO PARTICIPATE OR 
NOT TO PARTICIPATE IN A FREE AND INFORMED MANNER. YOU ARE ASKED TO READ 
THE FOLLOWING MATERIAL TO ENSURE THAT YOU ARE INFORMED OF THE NATURE 
OF THE RESEARCH STUDY AND OF HOW YOU WILL PARTICIPATE IN IT IF YOU 
CONSENT TO DO SO. SIGNING THIS FORM WILL INDICATE THAT YOU HAVE BEEN 
INFORMED AND THAT YOU GIVE YOUR CONSENT. 
INTRODUCTION 
There is no effective treatment for malignant brain tumors that recur following surgery, radiation 
therapy and/or chemotherapy. Therefore, we have developed a new experimental approach, for the 
treatment of recurrent brain tumors, that takes advantage of knowledge gained in the fields of 
genetics and gene therapy. A virus that causes mouth sores and other types of infections is called 
herpes simplex. It can be treated with a drug called Cytovene. The Herpes simplex virus is killed by 
Cytovene because the virus contains a specific gene called the Herpes-thymidine kinase gene (TK 
gene). The TK gene has been isolated in the laboratory and in experiments has been injected into brain 
tumors in rats. This causes the brain tumor cells containing the TK gene to be killed when the rats are 
treated with Cytovene. In some of the rats treated this way, the brain tumors disappeared. The 
purpose of this study is to gain information about whether or not this new approach is effective in 
treating human brain tumors. Although the findings in animals are encouraging, you will be one of 
the first humans to receive this investigational treatment for brain tumors. While we hope to gain 
information on the usefulness of this approach in humans, we cannot know whether your tumor will 
get smaller as a result of this treatment. It is possible that this treatment could make you worse. 
What is gene therapy for brain tumors? 
We will attempt to change the genetic material of your brain tumor cells by inserting the TK 
gene into the tumor cells. The way we will transport the TK gene into the tumor cells is to use a 
“vehicle” to carry the TK gene into the cells. An example is that if you want to move a passenger 
you need to put him in a car. The vehicle (or car) in this case a different virus - a retrovirus that is 
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