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

• DOI: 10.1007/s12325-011-0007-3
• Publication Date: 2011-03-24T02:13:39Z
• Authors: O. L. Chinot; T. de La Motte Rouge; N. Moore; A. Zeaiter; A. Das; H. Phillips; Z. Modrusan; T. Cloughesy
• Keywords: Adult; Angiogenesis Inhibitors; Antibodies, Monoclonal, Humanized; 03 medical and health sciences; 0302 clinical medicine; Clinical Protocols; Recurrence; Temozolomide; Humans; Pharmacology (medical); Antineoplastic Agents, Alkylating; Medicine(all); Radiotherapy; Brain Neoplasms; Antibodies, Monoclonal; Standard of Care; Prognosis; Combined Modality Therapy; 3. Good health; Bevacizumab; Dacarbazine; Europe; Treatment Outcome; Clinical Trials, Phase III as Topic; Glioblastoma

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.