A Story of Immunization with Autologous IFN-γ Secreting Glioma Cells in Patients with Glioblastoma Multiforme is Safe and Prolongs Both Overall and Progress Free Survival

Abstract

The study was a non-randomized controlled phase I-II trial to study were to ascertain the safety, feasibility and efficacy of immunotherapy with autologous IFN-γ transfected tumour cells in patients with glioblastoma multiforme. Autologous tumour cells harvested during surgery were cultured and transduced with the human IFN-γ gene. Irradiated cells were administered as intradermal immunizations every third week. Endpoints for safety were records of toxicity and adverse events, for feasibility the per cent of treated patients out of eligible patients and time to treatment and for clinical efficacy overall survival (OS) and progress free survival (PFS). Eight eligible patients, between 50 and 69 years, were immunized between 8 and 14 times after treatment with surgery and radiotherapy without adverse events or toxicity. Neurological status and quality of life were unchanged during immunotherapy. The immunized patients had a significantly (p < 0.05) longer median overall survival (488 days, 16.1 months than a matched control group of nine patients treated with only surgery and radiotherapy (271 days, 9.0 months). The prolongation of survival was also significant compared to all GBM treated at the same institution during the same period and published control groups within the same age cohort.