Can a cancer drug combo outsmart recurrent brain tumors?
NCT ID NCT03643549
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial is testing whether adding bortezomib to the standard chemotherapy temozolomide can help people with recurrent glioblastoma, a type of aggressive brain cancer. The study focuses on patients whose tumors have a specific genetic marker (unmethylated MGMT) that often makes them resistant to standard treatment. The goal is to see if the combination is safe and whether it can improve survival and slow tumor growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bortezomib combined with temozolomide
- What this could lead to
- If this combination works, it could offer a new treatment option for people with recurrent glioblastoma, potentially extending survival.
- What could go wrong
- This is an early-phase trial, so the benefits are uncertain. The drug combination may cause side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 63 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2018
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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) * Myocardial infarction within the past 6 months * NYHA class III or IV heart failure * Uncontrolled angina * Severe uncontrolled ventricular arrhythmias * Electrocardiographic evidence of acute ischemia or active conduction system abnormalities * 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 * 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 \[EIAED\])
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Haukeland University Hospital
RECRUITINGBergen, 5021, Norway
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Oslo University Hospital
RECRUITINGOslo, 0424, Norway
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