title: Evaluation of intratumoral administration of tumor necrosis factor-alpha in patients with malignant glioma.
abstract: BACKGROUND
  This study assessed safety and efficacy for intratumoral administration of tumor necrosis factor-a (TNF-SAM2) into the post-operative tumor cavity through an Ommaya reservoir for patients with malignant glioma.
  
  
  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 1x10(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.
  
  
  CONCLUSIONS
  Local immunotherapy with TNF-SAM2 may safely contribute to therapeutic efficacy in some patients with malignant glioma.
authors.affiliation: Department of Neurosurgery, Faculty of Medicine, Fukuoka University, 45-1, 7-chome, Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan. s-oshiro@fukuoka-u.ac.jp
authors.forename: Shinya
authors.initials: S
authors.lastname: Oshiro
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Tsugu
authors.forename: Fuminari
authors.initials: F
authors.lastname: Komatsu
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Ohnishi
authors.forename: Yushi
authors.initials: Y
authors.lastname: Ueno
authors.forename: Seizaburo
authors.initials: S
authors.lastname: Sakamoto
authors.forename: Takeo
authors.initials: T
authors.lastname: Fukushima
authors.forename: Gen-Ichiro
authors.initials: G
authors.lastname: Soma
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005910:Glioma / Q000276:immunology / Q000628:therapy*; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: C109083:TNF-SAM2; D014409:Tumor Necrosis Factor-alpha