CONSENT TO ACT AS A RESEARCH SUBJECT 
Injection of Colon Carcinoma Patients with Autologous Irradiated Tumor 
Cells and Fibroblasts 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 
be a 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 colon cancer. 
Purpose Of The Study 
My skin 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. The purpose of this study is to determine the safety of 
injecting patients with the genetically modified cells mixed with a sample of tumor cells. 
What Is Experimental About This Study 
The process of injecting cancer patients with genetically modified cells and their tumor 
cells is experimental. 
Number of Subjects 
Approximately 9 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: A small skin biopsy will be 
obtained from my back or arms. Skin cells obtained from the biopsy 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. 
In addition, a portion of my colon tumor removed during surgery will be saved and mixed 
with the genetically modified skin cells. The tumor and skin cell mixture will be injected 
underneath my skin. The 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 
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Recombinant DNA Research, Volume 18 
