Grade IV recurrent glioma which includes both glioblastoma, classified as IDH wt and grade IV IDH mutated astrocytoma.
Conditions
Brief summary
Phase IB of the trial: Assessment of safety and tolerability of Bortezomib administered with Temozolomide., Phase II: Assessment of efficacy of Temozolomide administered together with Bortezomib in recurrent glioblastoma. Overall survival (OS) at 1 year. Median OS from the 1st relapse. Progression free survival at 6 months. Median PFS from the 1st relapse. Time to progression.
Detailed description
Tumour response as assessed by contrast enhanced MRI using RANO criteria and neurological exam, [Time Frame: MRI at start of treatment and every 12th week, neurologic exam every 4 weeks]. If disease progression is suspected according to NANO criteria (clinical assessment) further confirmation with MRI (RANO) is required., Neurologic assessment according to NANO criteria [Time Frame: neurologic exam every 4 weeks], Identification of novel tumor biomarkers by determining physiological, molecular and biochemical changes in blood and tumor tissue that correlate with treatment responses
Interventions
DRUGBortezomib Accord 2.5 mg/mL solution for injection
DRUGBortezomib Viatris 3
DRUG5 mg pulver til injeksjonsvæske
DRUGoppløsning
Sponsors
Helse Bergen HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase IB of the trial: Assessment of safety and tolerability of Bortezomib administered with Temozolomide., Phase II: Assessment of efficacy of Temozolomide administered together with Bortezomib in recurrent glioblastoma. Overall survival (OS) at 1 year. Median OS from the 1st relapse. Progression free survival at 6 months. Median PFS from the 1st relapse. Time to progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumour response as assessed by contrast enhanced MRI using RANO criteria and neurological exam, [Time Frame: MRI at start of treatment and every 12th week, neurologic exam every 4 weeks]. If disease progression is suspected according to NANO criteria (clinical assessment) further confirmation with MRI (RANO) is required., Neurologic assessment according to NANO criteria [Time Frame: neurologic exam every 4 weeks], Identification of novel tumor biomarkers by determining physiological, molecular and biochemical changes in blood and tumor tissue that correlate with treatment responses | — |
Countries
Norway
Outcome results
None listed