SCIENTIFIC 
ABSTRACT 
This is an open, phase I clinical trial to evaluate the safety and efficacy of using an IL-2 
producing autologous tumor cell vaccine preparation in the treatment of advanced melanoma. 
The vaccine will be composed of irradiated melanoma cell line (M-24) genetically engineered 
to produce human interleukin-2 (IL-2) and irradiated fresh or cultured autologous tumor cells. 
Patients will receive biweekly vaccinations,. The following end-points will be measured: 1) 
toxicity, 2) generation of cytotoxic T lymphocyte (CTL) precursors, lymphokine-activated killer 
(LAK) cells and enhanced natural killer (NK) activity, 3) immunohistochemistry and delayed- 
type hypersensitivity of tumor skin tests and 4) clinical response of measurable lesions and/or 
duration of remission. 
NONTECHNICAL 
ABSTRACT 
The immune system has difficulty recognizing and destroying cancer cells. However, if cancer 
cells are genetically-engineered to produce interleukin-2 (IL-2), an immunostimulating growth 
factor, they appear to be much more effective in generating an anti-cancer immune response. 
In animal tumor vaccine experiments, it is not essential that the cancer cells themselves produce 
IL-2, as long as they are mixed with an IL-2 producing cell. 
In this clinical trial, patients with metastatic melanoma will be treated with a vaccine preparation 
consisting of their own melanoma cells mixed with a tissue culture melanoma line engineered 
to produce IL-2. The purpose of the IL-2 producing cell line is to provide for the continuous 
production of the immunostimulating growth factor n the vicinity of the patient’s tumor cells. 
The objective is to have the patient’s immune cells recognize their tumor as foreign and generate 
an anticancer response. 
The goals of this trial are to determine if an immune response is generated (using skin tests and 
lymphatic assays), whether any clinical responses are observed, and what sorts of toxicity are 
associated with this treatment. 
Recombinant DNA Research, Volume 18 
[419] 
