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Superselective intraarterial cerebral infusion of cetuximab after osmotic blood/brain barrier disruption for recurrent malignant glioma: phase I study.

Abstract
Objective To establish a maximum tolerated dose of superselective intraarterial cerebral infusion (SIACI) of Cetuximab after osmotic disruption of the blood-brain barrier (BBB) with mannitol, and examine safety of the procedure in patients with recurrent malignant glioma. Methods A total of 15 patients with recurrent malignant glioma were included in the current study. The starting dose of Cetuximab was 100 mg/m(2) and dose escalation was done to 250 mg/m(2). All patients were observed for 28 days post-infusion for any side effects. Results There was no dose-limiting toxicity from a single dose of SIACI of Cetuximab up to 250 mg/m(2) after osmotic BBB disruption with mannitol. A tolerable rash was seen in 2 patients, anaphylaxis in 1 patient, isolated seizure in 1 patient, and seizure and cerebral edema in 1 patient. Discussion SIACI of mannitol followed by Cetuximab (up to 250 mg/m(2)) for recurrent malignant glioma is safe and well tolerated. A Phase I/II trial is currently underway to determine the efficacy of SIACI of cetuximab in patients with high-grade glioma.
AuthorsShamik Chakraborty, Christopher G Filippi, Tamika Wong, Ashley Ray, Sherese Fralin, A John Tsiouris, Bidyut Praminick, Alexis Demopoulos, Heather J McCrea, Imithri Bodhinayake, Rafael Ortiz, David J Langer, John A Boockvar
JournalJournal of neuro-oncology (J Neurooncol) Vol. 128 Issue 3 Pg. 405-15 (07 2016) ISSN: 1573-7373 [Electronic] United States
PMID26945581 (Publication Type: Case Reports, Clinical Trial, Phase I, Journal Article)
Chemical References
  • Antineoplastic Agents, Immunological
  • Diuretics, Osmotic
  • Mannitol
  • Cetuximab
Topics
  • Adult
  • Aged
  • Antineoplastic Agents, Immunological (administration & dosage, adverse effects)
  • Blood-Brain Barrier (drug effects, metabolism)
  • Brain Neoplasms (diagnostic imaging, drug therapy, metabolism)
  • Cetuximab (administration & dosage, adverse effects)
  • Diuretics, Osmotic (therapeutic use)
  • Drug Therapy, Combination
  • Female
  • Glioma (diagnostic imaging, drug therapy, metabolism)
  • Humans
  • Infusions, Intra-Arterial
  • Male
  • Mannitol (therapeutic use)
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Recurrence, Local (drug therapy, metabolism)
  • Treatment Outcome

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