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The vaccine given to me will also consist of a melanoma cell line called "M-24" that has been 
genetically modified to produce interleukin-2. The interleukin-2 gene has been inserted into these cells 
using a mouse virus called a retrovirus. This inserted gene allows the melanoma cells to produce 
interleukin-2. Interleukin-2, is a hormone which stimulates the immune response. 
It is hoped that IL-2 production by cells mixed with my cancer cells will provoke an immune response 
against my tumor. 
I understand that my tumor cells and the melanoma cell line producing interleukin-2 will be mixed and 
injected into my skin using a small needle in up to four sites on either side of my body. These cells 
will receive x-ray treatment prior to vaccination to prevent the possible growth of my cancer cells at 
the injection site. Injection sites may be marked with a small spot of India Ink. My vaccination dose 
may be composed of different numbers of M-24 melanoma cells to test the effects of different doses of 
interleukin-2. I understand that I may receive vaccinations on weeks 0, 2, 4, 6, 8, 10, 12 and monthly 
thereafter for up to one year. Fewer treatments may be recommended if there are insufficient tumor 
cells or if I experience untoward side-effects. 
In an effort to understand if the vaccine is stimulating my immune system, I understand that several 
tests will be performed. If I have cancer deposits underneath my skin, I will have pretreatment and 
post-treatment pieces of tumor removed under local anesthesia using a 6 mm punch biopsy knife (no 
more than 5 biopsies at intervals no less than one month). These biopsies will not involve a cost to me. 
I may also be asked to receive a monthly skin test injection that will consist of my irradiated tumor cells 
without the M-24 melanoma cells cell line to monitor any immune response. These skin test sites may 
also be biopsied under local anesthesia using a 6 mm punch biopsy knife but I will be asked to submit 
to no more than 5 of these skin test biopsies. I understand that all biopsy procedures will require 
individual surgical consents and that I may refuse any without prejudice. 
RISKS, SIDE EFFECTS AND DISCOMFORT FOR PARTICIPANTS 
I know that at least one operation will be required to obtain enough tumor for vaccine preparation or 
culture. I will receive a separate informed surgical consent for this operation. There are some risks 
associated with the punch biopsies of tumor or skin test sites and include pain, bleeding and infection 
which are easily treated. 
I understand that the risks associated with vaccination include local pain, inflammation and possible 
infection at the injection site. Interleukin-2 production can cause tiredness, fever, chills, sweats, 
nausea, vomiting, shortness of breath, nasal congestion, confusion, seizures, low blood pressure, low 
urine output, heart attack, arthritis, vision changes, low blood counts, muscle pains, knee tenderness, 
infection, flu-like symptoms, unknown side-effects, migration of cancer cells in the experimental vaccine 
and death. Some of these side-effects, if they occur, may be treated by certain medications. Since this 
trial is designed to evaluate toxicity, all of my organ systems will be closely monitored for side-effects 
from treatment. 
Drawing of blood by vein may be associated with the complications of swelling, pain, bruising and 
rarely inflammation or infection. 
Recombinant DNA Research, Volume 18 
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