The University of Michigan Medical School 
and the Clinical Research Center 
CONSENT FORM 
(To be read by the Patient and explained to the 
Patient by his or her Physician). 
PROTOCOL: Adoptive Immunotherapy of Melanoma with Activated Lymph Node Cells Primed In Vivo 
with Autologous Tumor Cells Transduced with the IL-4 Gene 
PRINCIPAL INVESTIGATOR: Alfred E. Chang, M.D. 
CO-PRINCIPAL INVESTIGATORS: John C. Krauss, M.D. 
Scott E. Strome, M.D. 
Suyu Shu, Ph.D. 
PROTOCOL NUMBER: DATE: 
PATIENT NAME: HOSPITAL NO.: 
INTRODUCTION 
I am being invited to participate in a research study at the University of Michigan Medical Center. I 
understand that several general principles apply to all who take part in any experimental studies: 
1 . My participation in this study is voluntary. 
2. I may not personally benefit from this study, but knowledge may be gained from it that will 
benefit others. 
3 . I may withdraw from the study at any time for any reason without jeopardizing my further 
care. 
I am aware of the nature of the study, the risks, inconveniences, discomforts, and other 
information which are discussed in the following sections. 
DESCRIPTION OF TREATMENT 
I have a 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, 
I may not derive any direct benefit from it I understand that the purpose of this study is to determine the 
safety of this new treatment regimen which will attempt to cause tumor shrinkage. 
I will have removal of a sample of my own tumor which will be subsequently processed in a 
laboratory. The tumor will be modified in the laboratory by inserting a gene into the cells which will cause 
them to make a protein called interleukin-4 (EL-4). IL-4 is an immune hormone normally produced by the 
body. After this laboratory manipulation which will take 2 or 3 weeks, I will be injected with EL-4- 
modified tumor cells in one or two skin sites of my thigh or underarm areas. These modified tumor cells 
will be irradiated prior to injection into the skin in order to prevent their growth. About 7 to 10 days later I 
will undergo removal of lymph nodes that are adjacent to these injected skin sites in order to grow cells 
called lymphocytes that will later be given back to me as part of my treatment. The lymphocytes will be 
returned to me through an intravenous line placed in a blood vessel. In addition to these lymphocytes, I 
will receive interleulon-2 (IL-2), a protein normally made by the body's immune system that can help the 
immune cells function in my body. 
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