University of Michigan Medical School 
Department of Internal Medicine 
and the Clinical Research Center 
CONSENT FORM 
(To be read by the Patient and explained 
to the Patient by his or her Physician) . 
PROTOCOL : Immunotherapy of Malignancy bv in Vivo Gene Transfer into Tumors 
PRINCIPAL INVESTIGATOR: Gary J. Nabel, M.D., Ph.D. 
ASSOCIATE INVESTIGATORS: Alfred Chang, M.D. 
Elizabeth G. Nabel, M.D. 
Gregory Plautz, M.D. 
PROTOCOL NUMBER: 
DATE: 
PATIENT NAME: 
HOSPITAL NO.: 
INTRODUCTION 
We invite you to participate in a research study at the University of 
Michigan Medical Center. Several general principles apply to all who take 
part in any experimental studies: 
(1) Your participation in this study is voluntary 
(2) You may not personally benefit from this study, 
but knowledge may be gained from it that will benefit others 
(3) You may withdraw from the study at any time for any reason 
without jeopardizing your further care. 
The nature of the study, the risks, inconveniences, discomforts, and 
other information are discussed in the following sections. Please do not 
hesitate to discuss any questions you have about this study with the 
physicians who explain it to you. 
DESCRIPTION OF TREATMENT OR PROCEDURE TO BE UNDERTAKEN 
As you are aware, you have cancer which 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. 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 DNA or genetic material in bacteria. This DNA will be 
complexed to fat bodies, or liposomes, and injected into your tumor. We 
will insert DNA into these cells that causes them to produce a protein 
which stimulates tissue rejection. This protein is called HLA-B7 ; and it 
will cause cells which contain it to be recognized as foreign and rejected 
Recombinant DNA Research, Volume 15 
[455] 
