Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment

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 damag

Trial Details

NCT ID
NCT05432804
Phase
PHASE1 / PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Biospecimen Collection
  • Magnetic Resonance Imaging
  • Placebo Administration
  • Selinexor
  • Temozolomide
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Duarte, California, United States|34.13945,-117.97729
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Patients must have histologically confirmed glioblastoma (IDH wild-type, MGMT promoter methylated) that has undergone resection or biopsy upon firs…
  • Prior to resection or biopsy, patients must have measurable disease, defined as at least one bi-dimensional contrast-enhancing lesion with clearly …
  • Patients must have received first-line treatment of temozolomide plus radiotherapy
  • Patients must not have received any prior therapy aside from resection or biopsy for their recurrent disease

For full eligibility, visit ClinicalTrials.gov.

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