iDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
• Adult Patient or • Parent, for Minor Patient 
INSTITUTE: NATIONAL CANCER INSTITUTE 
STUDY NUMBER PRINCIPAL INVESTIGATOR: Steven A ‘ Rosenber §> M - D -> Ph.D 
STUDY TITLE: TMMTNT7.ATTON OF GANGER PATTENTS USING AUTOLOGOUS CANCER CELLS MODIFIED BY 
INSERTION OF THE GENE FOR INTERLEUKIN-2 
I 
INTRODUCTION 
We invite you (or your child) 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 
imbers who explain it to you. ^ 
Nature of Study 
The spread of your disease makes ineffective such standard therapies as 
drugs, surgery and radiation. We are attempting to develop a procedure that 
may help fight your type of cancer. The procedure that we are offering you is 
highly experimental. The purpose of the study is to attempt to immun ize you 
agains t your own cancer . It involves immunotherapy, using the body's own 
immune system to treat the cancer. In laboratory studies in mice we have shown 
that tumors that have had the gene for a substance called interleukin-2 (IL-2) 
inserted are more readily recognized as foreign by the immune system of the 
mouse and are rejected. These gene— modified tumor cells can be used to 
immunize mice against their own cancers. 
Earlier when your tumor was surgically removed, we grew a sample of it in 
the laboratory in tissue culture. We inserted the gene for IL-2 into, the 
cells of the tumor. The gene caused the cells of your tumor to produce IL-2. 
We propose to inject these gene— modified tumor cells in three sites in your 
Recombinant DNA Research, Volume 15 
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