MEDICAL 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 - Rosenberg, M.D., Ph.l 
STUDY TITLE: IMMUNIZATION OF CANCER PATIENTS USING AUTOLOGOUS CANCER CELLS MODIFIED 
BY INSERTION OF THE GENE FOR TUMOR NECROSIS FACTOR 
INTRODUCTION 
We Invite you (or your chi(d) 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 ail who take part in our studies: (a) taking part in the study 
is entirely voluntary; (b) personal benefit may not resuit 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. 
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 
immunize you against your own cancer. It involves immunotherapy, using the 
body's 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 tumor 
necrosis factor (TNF) 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 TNF into the cells 
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.•ATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
RESEARCH STUDY 
[82] 
Recombinant DNA Research, Volume 15 
NtH.9414-1 
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