A phase i study of vaccination with autologous, lethally irradiated melanoma cells engineered to secrete human gm-csf: A progress report
Head and Neck Neoplasms
During the past two years, investigators at the Dana-Farber Cancer Institute and the Massachusetts General Hospital have conducted a Phase I clinical trial involving the vaccination of patients with metastatic melanoma with autologous lethally irradiated tumor cells engineered to secrete human GM-CSF via retroviral mediated gene transfer. In this study, the safety, toxicity, and biological activity of immunization with transduced tumor cells have been assessed. In the study, patients were given a fixed dose of vaccine at either monthly, biweekly, or weekly intervals for three months. To date, twenty patients have completed treatment and are eligible for toxicity evaluation. A striking finding of the study is that in patients vaccinated at either biweekly or weekly intervals, a profound immune reaction has been consistently observed at distant sites of pre-existing tumor. The biological characteristics of those immune reactions will be reviewed.