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UNIVERSITY OF CALIFORNIA, LOS ANGELES 
CONSENT TO ACT AS A SUBJECT IN A RESEARCH PROJECT 
8/21/93 
TITLE: Genetically-Engineered Autologous Tumor Vaccines Producing Interleukin-2 for the 
Treatment of Metastatic Melanoma 
INVESTIGATORS: James S. Economou, M.D., Ph.D., John Glaspy, M.D., Jane Hobbs, R.N., 
Phillip Koeffler, M.D., William H. McBride, Ph.D., ScD., Robert Moen, M.D., Ph.D., Joseph 
Rosenblatt, M.D., Gary Schiller, M.D., Hungyi Shau, Ph.D., Dennis Slamon, M.D., Ph.D. 
1 . 
Patient’s Name UCLA ID Number 
I have the right to know about the procedures that are to be used in my participation in clinical 
research to afford me an opportunity to make the decision whether or not to undergo the procedure after 
knowing the risks and hazards involved. This disclosure is not meant to frighten or alarm me; it is 
simply an effort to make me better informed so I may give or withhold my consent to participate in 
clinical research. This informed consent does not supersede other informed consents I may have signed. 
I understand that I have been asked to participate in this study because I have a type of cancer, 
malignant melanoma, that is unlikely to respond to conventional therapy or one that has stopped 
responding to such therapy. 
Description or Research 
2. Purpose of study: I understand that this is a research study to treat me with an experimental 
preparation composed of a mixture of cells from my own tumor and a melanoma cell line, originally 
derived from a patient with melanoma, that has been genetically altered to produce interleukin-2, a 
hormone that stimulates the immune response. I am aware that the experimental preparation I am being 
asked to consider is unproven and that this is a Phase I Trial designed to evaluate its safety as much as 
its effectiveness. 
Before beginning treatment, I understand that I will undergo the following studies: a history and 
physical examination, an appropriate radiographic study (chest x-ray, Computed Tomogram or Magnetic 
Resonance Imaging scans), electrocardiogram, urinalysis, and blood tests which will require 6 
tablespoons of blood removed by needle puncture of a vein. (The schedule and number of tests are on 
page 5.) During the treatment/ test period, up to 11 blood-draws of 6 tablespoons of blood may be used. 
In order to prepare the vaccine, I understand that one or more subcutaneous (under the skin) tumors will 
have to be surgically removed from my body. I understand that I will receive separate, detailed, 
informed consent for this surgical procedure. This tumor will be used to prepare an experimental 
vaccine. I understand that an effort will be made to culture my tumor so that it can be grown into large 
numbers and that this cell line of my tumor may be used in the experimental vaccine preparation. The 
purpose of this vaccine is to stimulate my immune system to fight my cancer. It may require weeks 
or months to establish a cell line. 
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Recombinant DNA Research, Volume 18 
