title: Phase II trial of murine (131)I-labeled antitenascin monoclonal antibody 81C6 administered into surgically created resection cavities of patients with newly diagnosed malignant gliomas.
abstract: OBJECTIVE
  To assess the efficacy and toxicity of intraresection cavity (131)I-labeled murine antitenascin monoclonal antibody 81C6 and determine its true response rate among patients with newly diagnosed malignant glioma.
  
  
  METHODS
  In this phase II trial, 120 mCi of (131)I-labeled murine 81C6 was injected directly into the surgically created resection cavity of 33 patients with previously untreated malignant glioma (glioblastoma multiforme [GBM], n = 27; anaplastic astrocytoma, n = 4; anaplastic oligodendroglioma, n = 2). Patients then received conventional external-beam radiotherapy followed by a year of alkylator-based chemotherapy.
  
  
  RESULTS
  Median survival for all patients and those with GBM was 86.7 and 79.4 weeks, respectively. Eleven patients remain alive at a median follow-up of 93 weeks (range, 49 to 220 weeks). Nine patients (27%) developed reversible hematologic toxicity, and histologically confirmed, treatment-related neurologic toxicity occurred in five patients (15%). One patient (3%) required reoperation for radionecrosis.
  
  
  CONCLUSIONS
  Median survival achieved with (131)I-labeled 81C6 exceeds that of historical controls treated with conventional radiotherapy and chemotherapy, even after accounting for established prognostic factors including age and Karnofsky performance status. The median survival achieved with (131)I-labeled 81C6 compares favorably with either (125)I interstitial brachy-therapy or stereotactic radiosurgery and is associated with a significantly lower rate of reoperation for radionecrosis. Our results confirm the efficacy of (131)I-labeled 81C6 for patients with newly diagnosed malignant glioma and suggest that a randomized phase III study is indicated.
authors.affiliation: Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA. reard003@mc.duke.edu
authors.forename: David A
authors.initials: DA
authors.lastname: Reardon
authors.forename: Gamal
authors.initials: G
authors.lastname: Akabani
authors.forename: R Edward
authors.initials: RE
authors.lastname: Coleman
authors.forename: Allan H
authors.initials: AH
authors.lastname: Friedman
authors.forename: Henry S
authors.initials: HS
authors.lastname: Friedman
authors.forename: James E
authors.initials: JE
authors.lastname: Herndon
authors.forename: Ilkcan
authors.initials: I
authors.lastname: Cokgor
authors.forename: Roger E
authors.initials: RE
authors.lastname: McLendon
authors.forename: Charles N
authors.initials: CN
authors.lastname: Pegram
authors.forename: James M
authors.initials: JM
authors.lastname: Provenzale
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Quinn
authors.forename: Jeremy N
authors.initials: JN
authors.lastname: Rich
authors.forename: Lorna V
authors.initials: LV
authors.lastname: Regalado
authors.forename: John H
authors.initials: JH
authors.lastname: Sampson
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Shafman
authors.forename: Carol J
authors.initials: CJ
authors.lastname: Wikstrand
authors.forename: Terence Z
authors.initials: TZ
authors.lastname: Wong
authors.forename: Xiao-Guang
authors.initials: XG
authors.lastname: Zhao
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zalutsky
authors.forename: Darell D
authors.initials: DD
authors.lastname: Bigner
mesh_terms: D000328:Adult; D000368:Aged; D000906:Antibodies / Q000032:analysis; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D001254:Astrocytoma / Q000628:therapy; D001932:Brain Neoplasms / Q000401:mortality / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D005909:Glioblastoma / Q000628:therapy; D005910:Glioma / Q000401:mortality / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy; D007457:Iodine Radioisotopes; D008297:Male; D008875:Middle Aged; D009837:Oligodendroglioma / Q000628:therapy; D015996:Survival Rate; D019063:Tenascin / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D007457:Iodine Radioisotopes; D019063:Tenascin