This phase IB/II trial is designed to investigate the safety and survival benefits for patients with recurrent grade-4 with unmethylated MGMT promoter treated with Bortezomib and Temozolomide in a specific schedule.
Life expectancy > 8 weeks
Histologically confirmed intracranial glioblastoma (GBM), with MGMT unmethylated promoter
Must submit an unstained paraffin block and/ or cryopreserved tumour tissue from surgical procedure
Radiologically (MRI) confirmed tumour relapse/progression ≥ 12 weeks since completed radiotherapy
Hypersensitivity to Bortezomib, boron, or mannitol
Any contraindications for use of temozolomide
Peripheral neuropathy ≥ grade 2
Previous treatment with bevacizumab or lomustine alone or as a combination therapy for ralapsed glioblastoma (PCV as primary treatment of low grade glioma, before development of glioblastoma, is allowed)
Haukeland University Hospital
Lead sponsor
Oslo University Hospital
Collaborator
St. Olavs Hospital
Collaborator
University Hospital of North Norway
Collaborator
University of Bergen
Collaborator
University of Bonn
Collaborator
University of Oslo
Collaborator