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

NCT03643549 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-02-29

No results posted yet for this study

Summary

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.

Conditions

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

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • University of Bergen

    collaborator OTHER

  • University of Bonn

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Dorota Goplen, MD, PhD · Haukeland University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643549 on ClinicalTrials.gov