At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed glioblastoma, IDH wild-type, MGMT promoter methylated
- ✓Undergone resection or biopsy at first recurrence with histopathological evidence of viable neoplastic cells
- ✓Measurable disease: at least one bi-dimensional contrast-enhancing lesion with clearly defined margins, 2 perpendicular diameters ≥10 mm, visible on ≥2 axial slices
- ✓Prior first-line treatment with temozolomide plus radiotherapy
- ✕Prior bevacizumab therapy
- ✕Chemotherapy patients must have full recovery of organ and marrow function
- ✕Unrecovered adverse events from prior anti-cancer therapy (residual toxicities >grade 1, except alopecia)
- ✕Currently receiving other investigational agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 and Randomized Phase 2 Trial of Selinexor and Temozolomide in Recurrent Glioblastoma
In Brief
A Phase 2 clinical trial evaluating Biospecimen Collection, Magnetic Resonance Imaging, and 3 other interventions for Recurrent Glioblastoma, IDH-Wildtype and Recurrent MGMT-Methylated Glioblastoma. Currently recruiting, targeting 97 participants across 36 sites.
Detailed Summary
This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent). Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may keep cancer cells from growing and may kill them. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Giving selinexor in combination with usual chemotherapy (temozolomide) may shrink or stabilize the tumor better than the usual chemotherapy with temozolomide alone in patients with recurrent glioblastoma.
Study Details
Timeline
Interventions
Undergo blood sample collection
Undergo MRI
Given PO
Given PO
Given PO