MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
• Adult Patient or • Parent, for Minor Patient 
INSTITUTE: ninds 
STUDY NUMBER: 
PRINCIPAL INVESTIGATOR: Edward H. Oldfield m.d. 
STUDY TITLE: Gene Therapy for the Treatment of Brain Tumors Usinq Intra-Tu moral Transduction 
with the Thymidine Kinase Gene and Intravenous Ganciclovir 
INTRODUCTION 
We invite you to take part in a research study at the National Institutes of Health. It is important that you read and 
understand several general principles that apply to all who take part in our studies: (a) taking part in the study is entirely 
voluntary; (b) personal benefit may not result from taking part in the study, but knowledge may be gained that will 
benefit others; (c) you may withdraw from the study at any time without penalty or loss of any benefits to which you are 
otherwise entitled. The nature of the study, the risks, inconveniences, discomforts, and other pertinent information about 
the study are discussed below. You are urged to discuss any questions you have about this study with the staff members 
who explain it to you. 
There is no effective treatment for malignant brain tumors which 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. Herpes simplex 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 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. 
PATIENT 
IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
RESEARCH STUDY 
•Adult Patient or ©Parent, for Minor Patient 
Recombinant DNA Research, Volume 15 
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