Bortezomib and Temozolomide in Recurrent Grade-4 Glioma Unmethylated MGMT Promoter (BORTEM-17)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

August 30, 2018

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Glioblastoma
Interventions
DRUG

Bortezomib and Temozolomide Phase IB

In the Phase IB of the study the following dose escalation of TMZ will be performed: The first cohort of 3 patients will receive 150 mg/m2 of IMP (TMZ) for 5 days q4w. If one patient in this cohort develops a dose limiting toxicity, another cohort of 3 patients will be treated at the same dose level until 2 or more patients in the group of 3-6 develop DLT.

DRUG

Bortezomib and Temozolomide Phase II

The patientes will be treated with the maximum recommended starting dose of Temozolomide and Bortezomib established in the IB phase of the study

Trial Locations (2)

5021

RECRUITING

Haukeland University Hospital, Bergen

0424

RECRUITING

Oslo University Hospital, Oslo

All Listed Sponsors
collaborator

Oslo University Hospital

OTHER

collaborator

St. Olavs Hospital

OTHER

collaborator

University Hospital of North Norway

OTHER

collaborator

University of Bergen

OTHER

collaborator

University of Bonn

OTHER

collaborator

University of Oslo

OTHER

lead

Haukeland University Hospital

OTHER