APPENDIX D 
NONTECHNICAL ABSTRACT OF PROTOCOL 
Many patients have advanced cancer that has not responded to standard 
therapies. For these patients, a new approach to treat their cancer (tumor) will be 
tested. Animal studies have been done using cancer cells into which a cancer fighting 
gene has been placed. When these modified cancer cells are returned to the animal 
the animal can fight the cancer cells better. The returning of the gene modified cancer 
cells can be helpful in fighting the cancer cells in several ways. 
1 . Injecting tumor cells under the skin has shown to increase the responses of the 
animal's white cells in fighting the tumor cells. 
2. Before returning the cancer cells, they can be made to release a potent white 
cell activating factor (interleukin 2) by placing the gene for interleukin-2 into the 
tumor cells. If these gene modified cancer cells are used, the release of 
interleukin-2 by the cancer cells further increases the ability of the animal's 
white cells to fight the cancer cells by activating these white cells. 
3. In addition, it is possible to remove the activated white cells from the animal. 
These activated white cells can be grown up in the presence of interleukin-2 to 
very large numbers in the laboratory. If this large number of activated white 
cells grown in the laboratory is returned to the animal along with more 
interleukin-2, they also help fight the cancer cells in the animal. 
If all three parts are used together, an animal that would die from its cancer can now 
kill its cancer cells and live. 
This protocol is designed to copy the results obtained with the animals. 
Patients with cancer who have not responded to therapy will have a piece of their 
cancer cut out and brought to the laboratory. In the laboratory the cancer cells will 
be grown. The interleukin-2 gene will be put into the patient's cancer cells. The 
patient's cancer cells are now producing interleukin-2 and are grown in the laboratory. 
These cancer cells are then injected under the skin of the patient. In a few weeks 
white cells are removed from the area of injected cancer cells and grown to large 
numbers in the laboratory in the presence of interleukin-2. These cells along with 
interleukin-2 are then given to the patient. During this time and afterwards the patient 
is watched for signs that the therapy may be helping destroy their cancer. Since this 
therapy is new, it is not known how well it will work in people. The patients will also 
be watched for possible harmful effects from the therapy. After many patients with 
many different kinds of cancer have this new therapy, the doctors will be able to tell 
how safe this new therapy is and begin to assess how well it works. 
Recombinant DNA Research, Volume 15 
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