Evaluation of Intratumoral Administration of Tumor Necrosis Factor-alpha in Patients with Malignant Glioma

Background: This study assessed safety and efficacy for intratumoral administration of tumor necrosis factor-α (TNF-SAM2) into the post-operative tumor cavity through an Ommaya reservoir for patients with malignant glioma. Materials and Methods: Seven patients with malignant glioma, comprising 3 cases with glioblastoma multiforme (GBM), 3 cases with anaplastic astrocytoma (AA) and 1 case with malignant ependymoma (ME) were included in the study. All patients were pathologically diagnosed and initially treated with adjuvant therapy (radiation and/or ranimustine and/or systemic TNF-SAM2 infusion) following surgical resection. TNF-SAM2 was administrated into the post-operative tumor cavity through a reservoir at a concentration of 1×10 4 U/body when recurrence was detected, or as initial induction therapy concomitant with radiotherapy. Results: Partial response to this regional immunotherapy was seen in 4 out of 7 patients, and 1 patient with GBM has remained clinically stable for >184 weeks without tumor progression. With AA, 2 cases appeared to display slowed advance and longer times to tumor recurrence or regrowth. No serious adverse effects, such as brain edema, hemorrhage or seizure were observed, nor systemic toxicities. Conclusion: Local immunotherapy with TNF-SAM2 may safely contribute to therapeutic efficacy in some patients with malignant glioma.