Phase I/IIa trial of autologous formalin-fixed tumor vaccine for newly diagnosed glioblastoma.

Abstract

2069 Background: Autologous formalin-fixed tumor vaccine (AFTV) has been shown to have a potential role in effective adjuvant therapy for hepatocellular carcinoma and recurrent malignant glioma. We tried to determine the efficacy and safety of AFTV concomitant with radiation for newly diagnosed GBM patients from two institutions. Methods: Patients with supratentorial GBM who underwent debulking surgery were eligible. The AFTV was injected intradermally 3 times, with 7 days between injections, starting when the cumulative radiation dose reached 32-36 Gy. Results: A total of 24 patients were treated. Two patients were excluded by the radiation protocol or by the patient's consent. Although grade 1 dermal toxicity was observed at the injected sites in all patients, no grade 2 or higher hematologic or other toxicity was observed. The trial met the prospectively-defined primary endpoints, with 21.4 months median survival time (range 6.1 to 42 months), 40.0% 2-year survival, and 7.6 months median progression-free survival time (PFS, range 2.2 to 25.6 months). The PFS of the patients with greater delayed type hypersensitivity (DTH) reaction (13.9 months) was statistically longer (p < 0.01) than that of the patients with weaker DTH reaction (4.3 months). Conclusions: The AFTV immunotherapy concomitant with radiation is a safe treatment for patients with newly diagnosed GBM and seems to have a positive effect on the PFS. Additional testing of AFTV in combination regimens is warranted. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Cell-Medicine, Inc. Cell-Medicine, Inc.