277. Clinical Evaluation of Dendritic Cell Vaccination for Patients with Recurrent Glioma: Results of a Clinical Phase I/II Trial

Abstract

Purpose: To investigate the safety, immunological and clinical responses of dendritic cell (DC) therapy for patients with recurrent malignant glioma. Experimental Design: Twenty-four patients with recurrent malignant glioma (6 grade III and 18 grade IV patients) were evaluated in a phase I/II clinical study of DC therapy. All patients were resistant to the standard maximum therapy. The patient's peripheral blood DCs were generated with GM-CSF, plus IL-4 with or without OK-432, and pulsed with an autologous tumor lysate. DCs were injected intradermally, or both intratumorally and intradermally every 3 weeks. Results: The protocols were well tolerated with only local redness and swelling at the injection site in several cases. Clinical responses were: 1 patient with partial response, 3 patients with minor response, 10 patients with stable disease, and 10 patients with progressive disease. The patients who's DCs were maturated with OK-432 had longer survival times than the DCs from patients without OK-432 maturation. The patients with both intratumoral and intradermal administrations had a longer survival time than the patients with intradermal administration only. Increased ELISPOT and DTH responses after vaccination could provide good laboratory markers to predict the clinical outcome of patients receiving DC vaccination. The overall survival of patients with grade IV glioma was 480 days, which was significantly better than that in the control group. Conclusions: This study demonstrated the safety and clinical response of autologous tumor lysate-pulsed DC therapy for patients with malignant glioma. DC therapy is recommended for further clinical studies in malignant glioma patients.