APPENDIX A 
MEMORIAL HOSPITAL 
1275 YORK AVENUE 
NEW YORK, NEW YORK 10021 
PATIENT INFORMED CONSENT FOR CLINICAL RESEARCH 
You are being asked to participate in a clinical research study. The doctors at 
Memorial Hospital study the nature of disease and attempt to develop improved 
methods of diagnosis and treatment. This is called clinical research. In order to 
decide whether or not you should agree to be part of this research study, you 
should understand enough about its risks and benefits to make an informed 
judgment. This process is known as informed consent. 
This consent form gives detailed information about the research study which the 
doctor will discuss with you. Once you understand the study, you will be asked to 
sign this form if you wish to participate. You will have a copy to keep as a record. 
The research study being proposed to you is: 
A PILOT STUDY OF IMMUNIZATION WITH HLA-A2 MATCHED 
ALLOGENEIC MELANOMA CELLS THAT HAVE BEEN ALTERED TO 
SECRETE INTERLEUKIN-2 IN PATIENTS WITH METASTATIC MELANOMA 
PURPOSE OF THE RESEARCH STUDY 
Treatment of patients with metastatic melanoma has been disappointing. In rare 
patients, the cancer has spontaneously disappeared. This has suggested that an 
individual patient’s immune system can be capable of fighting the cancer. For these 
reasons, novel treatments that can increase an individual’s immune response against 
his/her melanoma are being studied. 
The purpose of this study is to evaluate a vaccine made as a result of the new 
technique called gene therapy. The vaccine is made from tumor cells that have been 
altered by gene therapy in order to make interleukin-2 (IL-2). Interleukin-2 is a 
protein made by certain blood cells that can stimulate an immune response. In 
earlier studies cancer patients have received large doses of IL-2. Some of these 
patients had reductions in the size or number of their tumors. Most of them 
experienced side effects, sometimes severe. Many of the side effects were a result 
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