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There is a very small chance that this treatment may cause a new cancer. I understand that the vaccine 
preparation will be irradiated and should be incapable of growth. The M-24 melanoma cells modified 
to produce interleukin-2 has the remote possibility of producing an infectious virus that could infect 
other cells in my body and cause a new cancer. There is also the possibility that an immune response 
may be generated that attacks a normal organ of my body. Because of the possibility of an allergic 
response to the melanoma cell line, I understand that I will have a skin test prior to each vaccination. 
If I could potentially bear a child, I will not participate in this research protocol unless, with the 
investigator’s knowledge and approval, I am employing a medically acceptable form of birth control 
(contraception). This research may have unforeseeable risks to an embryo or fetus. A pregnancy 
screening test will be performed at no cost to me and a negative result will be required prior to the 
initiation of therapy. 
POTENTIAL BENEFITS 
I understand that there may be no direct benefit to me from study participation, and there is a possibility 
my condition may become worse. However, a better understanding of immunity to cancer may be 
gained by my participation that would benefit society in general. 
ALTERNATE PROCEDURES OR TREATMENT 
This experimental trial is offered to me because my cancer is advanced and alternate methods of therapy 
- surgery, chemotherapy and/or radiation therapy - have not proven beneficial or are still being tested. 
UNDERSTANDING OF PARTICIPANTS 
I have been given an opportunity to ask any questions concerning the investigational cancer treatment 
regimen involved and the investigator has been willing to reply to my inquiries. The 11-2 producing 
M-24 melanoma cells and my own melanoma cells will be administered under the above numbers, title 
and described clinical research protocol at this institution. I hereby authorize Dr. James S. Economou 
and my attending physician/investigator and designated physician associates to administer the 
investigational cancer treatment for the purpose of determining its side-effects and effect on my immune 
system. 
I have been told and understand that my participation in this clinical research study is voluntary. I may 
decide not to participate, or withdraw my consent and discontinue my participation at any time. Such 
action will be without prejudice and there shall be no penalty or loss of benefits to which I may 
otherwise be entitled, and I will continue to receive treatment by my physician at this institution. I 
understand that circumstances may arise which might cause the investigator to terminate my 
participation before completion of the study. 
If I decide not to participate or withdraw my consent from participation in this clinical research, I 
understand that I should discuss the potential consequences or effects of my decision with my physician. 
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Recombinant DNA Research, Volume 18 
