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

Study acronym: BORTEM-17
StatusRecruiting
PhasePhase 1/2
Started2018-08-30
View on ClinicalTrials.gov ↗

Amendment history

2026-08-02
minor
Study Status v6
Primary completion date2025-06-30→2026-12-30
Completion date2025-12-31→2026-12-31
2024-02-27
minor
Study Identification, Study Status, Study Description v5
Primary completion date2022-12-31→2025-06-30
Completion date2023-08-30→2025-12-31
Study title-3 characters
Bortezomib and Temozolomide in Recurrent GlioblastomaGrade-4 WithGlioma Unmethylated MGMT Promoter (BORTEM-17)
2021-08-24
minor
Study Identification, Study Status, Study Design, Outcome Measures, Eligibility v4
Eligibility criteria+176 characters
[...] rable recurrent tumor Tumor not available for radio-surgery If previously treated with gammaknife, at least one evaluable lesion outside the irradiated area is required, unless the time after the radiosurgery is 12 weeks or more Written informed consent for study participation and tumour, [...] y study related procedure. Karnofsky performance status ≥ 70% WBC ≥ 3,000/mm^3 ANC ≥ 1,500/mm^3 Platelet count ≥ 100,000/ [...] dium > 130 mmol/L Serum potassium level within normal limit Stable or reduced doses of corticosteroids for at least 1 week prior to enrolment Negative pregnancy test no longer than 14 days p [...] [...]
Secondary endpoints3 to 4 entries
Toxicity assessment
2020-02-10
minor
Study Status, Eligibility, Contacts/Locations v3
Primary completion date2021-08-31→2022-12-31
Completion date2023-08-31→2023-08-30
Study sites1→2
Eligibility criteria+280 characters
[...] eparin allowed Stable or decreasing steroid dose during the twolast weeksweek before study entry Patients previously treated with neurosu [...] neuropathy ≥ grade 2 Previous treatment with bevacizumab or PCVlomustine alone or as a combination therapy for ralapsed glioblastoma (PCV as primary treatment of low grade glioma, before development of glioblastoma, is allowed) Myocardial infarction within the past 6 months [...] nal drugs must be stopped at least 12 weeks prior to therapy or treatment failure under other experimental therapy must be confirmed before study entry. If progression during other experim [...] [...]
2018-08-31
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-09-17→confirmed 2018-08-30
Study sitesdetails revised at 1 of 1 site
2018-08-27
minor
Study Status, Arms and Interventions v1
InterventionsBortezomib and Temozolomide (Drug)→Bortezomib and Temozolomide Phase IB (Drug), Bortezomib and Temozolomide Phase II (Drug)
2018-08-21
minor
Original filing
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.
Trial Details
NCT Number NCT03643549
Lead Sponsor Haukeland University Hospital
Collaborators: Oslo University Hospital, St. Olavs Hospital, University Hospital of North Norway, University of Bergen, University of Bonn, University of Oslo
Conditions Glioblastoma
Enrollment 63 participants
Start Date 2018-08-30
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-04