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: a 
Rn<5<anhpTo- M “n T 
gyijQY TITLE’ CENE THERAPY OF PATIENTS WITH ADVANCED CANCER USING TUMOR 
INFILTRATING 
LYMPHOCYTES TRANSDUCED WITH THE GENE CODING FOR TUMOR NECROSIS FACTOR 
INTRODUCTION 
We invite you (or your child) to take part in a research study at the National Institutes of HealthTlt is important that 
read and understand several general principles that apply to all who take part in our studies: (a) takinc part in the st 
is entirely voluntary; (b) personal benefit may not result from taking part in the study, buLknowPedge may be gained • 
will benefit others; (c) you may withdraw from the study at any time without penalty or loss of any benefits to which 
are otherwise entitled. The nature of the study, the risks, inconveniences, discomforts, and other pertinent informa 
about the study are discussed below. You are urged to discuss any questions you have about this study with the = 
members who explain it to you. 
Nature of the Study ; 
Your disease has spread to portions of your body so that s-tandard therapy such as 
drugs, surgery, and radiation are no longer effective (beneficial). Treatments will 
be offered to you in this study that may help fight your disease. But because these 
treatments are experimental, it is not possible to determine if you will receive any 
direct benefit from them. The purpose of this study is to determine the maximum 
doses of a treatment consisting of your own gene-modified immune lymphocytes and 
interleukin-2 that can be administered to patients. Since this is a new, experi- 
mental treatment we will also be observing you to determine the side effects of the 
therapy. In addition, we will monitor the effects of treatment on the growth of your 
tumor. IL-2 Is a biological substance normally produced in human cells In small 
quantities. By using new techniques in the laboratory it can be produced in large 
amounts in bacteria in order to be given to you in larger quantities than is normally 
produced in your body. Also, we will try to isolate some lymphocytes (a type of 
immune cell) from your tumor, which will be grown in large numbers in the laboratory. 
We will Insert a gene into these cells that causes them to produce increased amounts 
of a substance called tumor necrosis factor (TNF) and then give these cells back to 
you. The purpose of giving you your own lymphocytes is that we hope these lymphocytes 
(TIL) will attack and kill your tumor. This type of therapy using immune cells is 
called immunotherapy. There are no known curative treatments for patients with your 
disease. Some doctors use chemotherapy (drug) treatments. The option also exists to 
receive no treatment at this time. 
Procedures 
Before receiving any drug therapy, you will have a number of tests to evaluate if you 
qualify for this study. These tests will be done on an inpatient or outpatient basis 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
RESEARCH STUDY 
• Adult Patient or • Parent, for Minor Patie. t 
Recombinant DNA Research, Volume 14 
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