Bortezomib with temozolomide for returning grade 4 brain tumors
Tests bortezomib plus temozolomide in adults with a returning grade 4 glioma.
Plain-language title generated from the registry record
Registry title: Bortezomib and Temozolomide in Recurrent Grade-4 Glioma Unmethylated MGMT Promoter (BORTEM-17)
Key facts
- Where
- Bergen, Oslo, Tromsoe, and Trondheim, NorwaySee the 4 sites
- Phase
- Phase 1/2
Where in Norway
- Helse Bergen HFBergen, NorwayTaking people
- Oslo University Hospital HFOslo, NorwayTaking people
- Universitetssykehuset Nord-Norge HFTromsoe, NorwayTaking people
- St. Olavs hospital HFTrondheim, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haukeland University Hospital
- Trial code
- NCT03643549EU 2024-515142-16-00
- Record updated
- 4 August 2026
- Original description
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.Read full original descriptionShow less
Bortezomib Sensitization of Recurrent Grade-4 Glioma With Unmethylated MGMT Promoter to Temozolomide Phase 1B/II Study
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.
Inclusion: 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; Measurable 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, blood sample collection obtained before performance of any study related procedure; Karnofsky performance status ≥ 70; WBC ≥ 3,000/mm\^3; ANC ≥ 1,500/mm\^3; Platelet count ≥ 100,000/mm\^3; Hemoglobin ≥ 10 g/dL (transfusion allowed); Bilirubin < 2.5 times upper limit of normal (ULN); serum aspartate aminotransferase (AST) < 2.5 times ULN; Estimated GFR ≥ 60 mL/minute; Serum sodium > 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 prior to enrollment; Fertile patients and female partners with child bearing potential of male patients must use adequate contraception; Patients on EIAED must be transitioned to non-EAIED for ≥ 2 weeks; Unfractionated and/or low molecular weight heparin allowed; Patients previously treated with neurosurgery er eligible for the study.
Exclusion: Any contraindications for use of temozolomide; 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); Other investigational 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 experimental therapy is confirmed, the time interval between previous treatment and BORTEM-17 may be reduced to 4 weeks; Concurrent inducers of CYP450 3A4 (e.g., enzyme-inducing anti-epileptic drugs [EIAED]); Hypersensitivity to Bortezomib, boron, or mannitol; Myocardial infarction within the past 6 months; NYHA class III or IV heart failure; Uncontrolled angina; Severe uncontrolled ventricular arrhythmias; Known heart failure; Serious medical or psychiatric illness that would interfere with the study participation including, but not limited to, any of the following:; Ongoing or active infection requiring IV antibiotics; Psychiatric illness and/or social situations that would limit compliance with study requirements; Disorders associated with a significant immunocompromised state (e.g., HIV, systemic lupus erythematosus); History of stroke within the past 6 months; Other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy (i.e., cervical cancer), or low-risk prostate cancer after curative therapy; Significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; Disease that will obscure toxicity or dangerously alter the drug metabolism; Viral hepatitis (HBV surface antigen positive) or active hepatitis C infection; Peripheral neuropathy ≥ grade 2; Electrocardiographic evidence of acute ischemia or active conduction system abnormalities.