12.4 Patient Informed Consent Form 
Informed Consent 
CONSENT TO ACT AS A RESEARCH SUBJECT 
Injection of Glioblastoma Patients with Tumor Cells Genetically Modified to Secrete Interleukin-2 
(IL-2): A Phase I Study 
I am being asked to participate in a research study. However, before I give my consent to volunteer, it is 
important that I read the following materials and ask as many questions as necessary to be sure that I 
understand what my participation will involve. 
Investigator and Sponsor 
Dr. Robert E. Sobol and his colleagues are conducting an experimental study to learn more about 
methods to transfer genes into cancer patients' cells that may enhance the body's immune responses 
against cancer. I have been asked to take part in this study because I have a glioblastoma, a form of 
brain cancer. 
Purpose Of The Study 
The purpose of this study is to determine the safety of injecting patients with genetically modified tumor 
cells. Tumor cells will be altered in the laboratory by having a new gene inserted to generate a substance, 
termed interleukin-2, which has been shown to stimulate anti-tumor immune responses in some cancer 
patients. 
What Is Experimental About This Study 
The process of injecting cancer patients with genetically modified tumor cells is experimental. 
Number of Subjects 
Approximately 30 patients will be treated. 
Duration Of Study and Procedures To Be Followed 
If I agree to be in this study, the following will happen to me: Either my own or another patient's 
genetically modified tumor cells will be injected underneath my skin. The tumor cells will have been 
treated with x-rays to prevent their ability to grow. These injections are similar in nature to those 
utilized for routine vaccinations. I will receive three of these injections at two week intervals. All 
injections will be administered to me as an outpatient. Following each injection, I will be observed for 
one hour to identify any side-effects of treatment. Subsequently, I will be contacted daily for three days 
following each injection and I will come to the clinic to be examined if redness or swelling develops at the 
injection sites. I will also be examined every two weeks during the first 8 weeks of the study, once a 
month for three months and every 3 months for one year after the completion of therapy and at least 
yearly thereafter to identify any side-effects of treatment and to evaluate the effects of these injections on 
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