3055484975 
DIU. OF HEM/ONC 
F-400 T-119 P-005/007 PUG 20 ’93 16 
Phase I Study of Transfected Cancer Cells Expressing the lnterleukin-2 Gene in Limited 
Stage Small-Cell Lung Cancer. 
Patient’s Informed Consent Form 
Research Study 
I, willing agree to participate in this research 
study which has been explained to me by Dr. . This study is being 
conducted at the University of Miami School of Medicine. 
Purpose of the Study 
It has been explained to me that I have small-cell cancer of the lung. I have been invited to 
participate in a research study. I understand that the study is being undertaken in an effort to 
evaluate the safety and effectiveness of the treatment described below and gain information about 
my disease. Although the intent is to slow, decrease, or stop the growth of my cancer, I realize 
that it is impossible to predict whether any benefit will occur from my participation in this study. 
Description of Procedures 
In this investigative treatment protocol, cancer cells obtained from me by biopsy will be cultured 
to grow the cells in test tubes. Although these cells may be available from the biopsy taken to 
make the diagnosis of lung cancer, I understand that a second biopsy may be needed for the 
purposes of this research study. The second biopsy, if needed, may require only local 
anesthesia, but could also involve general anesthesia and mediastinoscopy (passage of a tube 
behind the sternum through an incision at the base of the neck) with its attendant risks, which are 
described below. Genetic material that instructs cells to produce a substance called lnterleukin-2 
will be inserted into the cancer cells by means of a gene carrying system called a plasmid. This 
gene carrying system includes the transfer into the cells of a portion of the bovine papilloma virus 
1 , a virus that causes tumors in cows. The cells are then cultured for additional time so that they 
reproduce, making many more cells. These cells will be removed from culture and treated with 
radiation therapy so that they cannot regrow in my body but will still be alive. They will then be 
injected under the skin of one of my forearms. These injections will be done initially once, again 
in two weeks, and then every week for 4-6 weeks thereafter. 1 will be hospitalized for 24 hours 
after the initial injection for observation for any immediate side effects. If there is a good 
response to treatment, it is possible that additional injections may be administered. I understand 
that the intent is that the tumor cells returned under the skin of my arm will produce lnterleukin-2, 
which is a substance that stimulates the immune system to produce cells which can attack and 
kill cancer cells. The hope is that the repeated injections will cause my body to make these 
cancer-cell killers in adequate numbers not only to attack the cancer cells which have been 
injected under my arm but also to circulate in the blood and destroy other cancer cells that remain 
in my body. Although this treatment technique has been shown to be effective in lung cancer in 
mice, this approach has not been used in humans before. Administration of lnterleukin-2 alone 
into a vein in very high doses can stimulate the immune system to destroy some cancers in a 
small number of patients. The administration of lnterieukin-2 in those very high doses has many 
severe side effects. The amount of lnterleukin-2 made by the tumor cells in this study that will 
be returned to me will be substantially less. 
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Recombinant DNA Research, Volume 18 
