A Phase 1 and Randomized Phase 2 Trial of Selinexor Combined with Temozolomide Compared to Temozolomide Alone in Recurrent Glioblastoma

What this Trial Is About

Researchers are studying the safety, side effects, and best dose of selinexor combined with the usual chemotherapy drug temozolomide in patients with glioblastoma that has returned after previous treatment. This phase I/II trial compares the combined treatment to temozolomide alone to see if adding selinexor can better shrink or stabilize the tumor. Selinexor works by blocking a protein called CRM1, which may stop cancer cells from growing, while temozolomide damages tumor cell DNA to slow growth. In this trial, patients are randomly assigned to one of two groups. One group receives temozolomide alone on days 1-5 of each 28-day cycle with placebo on days 8 and 15. The other group gets temozolomide on days 1-5 and selinexor on days 8 and 15 of each cycle. Treatment cycles repeat every 28 days unless the disease worsens or side effects become unacceptable. Patients have MRI scans and blood samples taken during the study to monitor the tumor and treatment effects. Participants are followed regularly through MRI and blood tests while on treatment and every two months for up to two years after treatment ends. Researchers measure progression-free survival, overall response to treatment, survival rates, and molecular markers to understand how well the treatments work and their safety. The study aims to find the best dose of selinexor and evaluate if the combination improves outcomes compared to chemotherapy alone.

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