THE UNIVERSITY OF CHICAGO 
DIVISION OF BIOLOGICAL SCIENCES 
Informed Consent 
Consent By Subject For Participation in Research Protocol 
Protocol Number: Patient Name: 
Title of Protocol: Phase I Study of Immunotherapy for Metastatic Renal Cell 
Carcinoma by Direct Gene Transfer into Metastatic Lesions 
Doctor(s) Directing Research: Nicholas J. Vogelzang, M.D. (312-702-67431 
Timothy M. Lestingi, M.D. (312-753-3636) 
Gary Sudakoff, M.D. (312-702-2562) 
You are being asked to participate in a research study. The doctors at 
the University of Chicago Hospitals and the Division of The Biological 
Sciences study the nature of disease and attempt to develop improved methods 
of diagnosis and treatment. In order to decide whether or not you want to be 
a part of this research study, you should understand enough about its risks 
and benefits to make an informed judgement. This process is known as informed 
consent. This consent form gives detailed information about the research 
study which will be discussed with you. Once you understand the study, you 
will be asked to sign this form if you wish to participate. 
I. NATURE AND DURATION OF PROCEDURE(S) : 
As you are aware, your kidney cancer cannot be cured by medicine, 
surgery, or radiation. In this study, treatments will be offered that 
may help to fight this disease in future patients. Because the 
treatment is experimental, you may not derive any direct benefit from 
it. The purpose of this study is to determine a safe and effective dose 
of a new treatment which will attempt to induce tumor regression in 
patients with widespread kidney cancer. Because this is a new, 
experimental treatment, we will also be observing you to determine the 
side effects’of the therapy. We will also monitor the effects of this 
treatment on the growth of your tumor. 
By using techniques in the laboratory, it is now possible to 
prepare large amounts of human DNA or genetic material in bacteria. 
This DNA will be mixed with fat bodies called liposomes, and we plan to 
transport the mixture into your tumor by needle injection. Once 
introduced into the tumor, the DNA produces proteins which stimulate 
tissue rejection. One protein -- known as HLA-B7 -- causes the cells 
which contain it to be recognized as "a foreign enemy" by your immune 
system and, in some cases, a second protein, called interleukin-2, will 
be made. This protein also causes activation of your immune system. 
The purpose of our study is to determine whether this treatment will ' 
induce the cells of your immune system, known as lymphocytes, to attack 
and kill your tumor. This type of therapy which stimulates your 
lymphocytes is called immunotherapy. 
Before receiving this treatment, you will receive many tests to 
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