AVAglio: Phase 3 trial of bevacizumab plus temozolomide and radiotherapy in newly diagnosed glioblastoma multiforme

Adv Ther. 2011 Apr;28(4):334-40. doi: 10.1007/s12325-011-0007-3. Epub 2011 Mar 14.

Abstract

Despite treatment with the current standard-of-care therapies, patients with newly diagnosed glioblastoma multiforme (GBM) exhibit dismal prognoses. Bevacizumab has demonstrated activity in patients with recurrent GBM and phase 2 trials indicate that the combination of bevacizumab with standard-of-care therapy is feasible and active for patients with newly diagnosed GBM. Bevacizumab has been granted US approval for use as single-agent therapy for patients with progressive GBM following prior therapy, although it has not received approval for use in patients with GBM in Europe. Phase 3 studies have been initiated in patients with newly diagnosed GBM and are currently recruiting patients. We describe the protocol for the AVAglio phase 3 registration trial, which is designed to evaluate the efficacy and safety of combining bevacizumab with standard-of-care therapy in patients with newly diagnosed GBM.

Publication types

  • Clinical Trial, Phase III

MeSH terms

  • Adult
  • Angiogenesis Inhibitors / administration & dosage
  • Angiogenesis Inhibitors / adverse effects
  • Antibodies, Monoclonal* / administration & dosage
  • Antibodies, Monoclonal* / adverse effects
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents, Alkylating / administration & dosage
  • Antineoplastic Agents, Alkylating / adverse effects
  • Bevacizumab
  • Brain Neoplasms / diagnosis
  • Brain Neoplasms / therapy
  • Clinical Protocols
  • Clinical Trials, Phase III as Topic
  • Combined Modality Therapy
  • Dacarbazine / administration & dosage
  • Dacarbazine / adverse effects
  • Dacarbazine / analogs & derivatives*
  • Europe
  • Glioblastoma / diagnosis
  • Glioblastoma / therapy*
  • Humans
  • Prognosis
  • Radiotherapy*
  • Recurrence
  • Standard of Care
  • Temozolomide
  • Treatment Outcome

Substances

  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents, Alkylating
  • Bevacizumab
  • Dacarbazine
  • Temozolomide