ABSTRACT OF PROTOCOL 
This protocol is a study of patients with metastatic melanoma who have failed standard 
therapy. In an attempt to increase the patient’s immune response to the tumor, the interleukin-2 
(IL-2) gene will be introduced into a human melanoma cell line (M-24). This gene-modified 
melanoma cell line producing IL-2 will then be mixed with tumor cells obtained from the 
patient. This mixture of cells will be irradiated to prevent possible growth and injected 
subcutaneously into the patient. This injection is expected to augment the immune responses of 
the patient to tumor cells through the immune stimulatory effects of the IL-2 secreted by the 
gene-modified cells. Animal models have shown the injection of gene modified cells has 
important antitumor effects. To determine the safety of the procedure, a constant number of 
tumor cells will be mixed with escalating numbers of IL-2 producing cells. 
The patients will be evaluated for antitumor effects engendered by the injection of the 
gene modified cells mixed with patient tumor cells. The injection of gene modified cells with 
the tumor cells may serve to "immunize" the patient to their tumor and may be amenable to use 
in a wide variety of tumor types. This protocol differs from other previous IL-2 "tumor 
vaccines" in that a wider range of patients and tumor types can potentially be treated as tumor 
cell lines from each patient do not need to be established. 
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. 
One of the cancer fighting genes that can be placed in these cancer cells is a white cell activating 
factor (interleukin 2). If the gene for interleukin-2 is placed into the tumor cells the tumor cells 
are made to release interleukin-2. 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. 
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 mixed with another cell 
that has been made to release interleukin-2. The patient’s cancer cells mixed with the 
interleukin-2 producing cells are then injected under the skin of the patient. Every few weeks 
the patient will return to the clinic to receive an additional injection of mixed cells. The amount 
of interleukin-2 releasing cells will be gradually increased during the period the person receives 
the injections. During this time and afterwards the patient is watched for signs that the therapy 
may be activating white cells that could be helpful in destroying cancer cells. Since this therapy 
is new, it is not known how well it will work in people. The patients will 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. The information the doctors gain from this study may permit 
the doctors to develop better ways of treating patients with cancer. 
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