Testing the Addition of Selinexor to Usual Chemotherapy for Brain Tumors That Have Returned After Treatment

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05432804

Provider View

This clinical trial is exploring whether adding the drug selinexor to the usual chemotherapy treatment, temozolomide, can improve outcomes for patients with glioblastoma, a type of brain tumor, that has come back after previous treatment.

Patient Parameters

Program Overview

This study is investigating the safety and best dose of selinexor when combined with the standard chemotherapy drug temozolomide for treating recurrent glioblastoma, a type of brain tumor. Selinexor works by blocking a protein that helps cancer cells grow, while temozolomide damages the DNA of cancer cells to stop their growth. The trial aims to see if this combination can shrink or stabilize tumors better than temozolomide alone.

Description

The study has two main parts: Phase I and Phase II.

In Phase I, researchers will determine the safest dose of selinexor when given with temozolomide by monitoring side effects and overall safety. In Phase II, the effectiveness of the combination will be compared to temozolomide alone by looking at how long patients live without the cancer getting worse.

Participants will be randomly assigned to one of two groups:

  • Group I: Will receive temozolomide alone, taken by mouth for five days in each 28-day cycle.
  • Group II: Will receive both temozolomide and selinexor, with temozolomide taken for five days and selinexor taken on days 8 and 15 of each cycle.

Throughout the study, participants will have regular MRI scans and blood tests to monitor their health and the treatment's effects. After finishing the treatment, follow-up visits will occur every two months for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of glioblastoma that has returned after initial treatment.
  • Must have had surgery or a biopsy to confirm the tumor's return.
  • Must have measurable disease visible on scans.
  • Must have received initial treatment with temozolomide and radiotherapy.
  • Must be 18 years or older.
  • Must have good overall health and organ function as indicated by specific blood tests.
  • Must not have received any other treatment for the recurrent tumor aside from surgery or biopsy.
  • Must agree to use effective birth control during the study and for a specified time after treatment.
  • Must be able to understand and sign a consent form, or have a representative who can do so.

Exclusion Criteria

  • Must have recovered from any side effects of previous cancer treatments.
  • Must not be taking any other experimental drugs.
  • Must not have received the drug bevacizumab before.
  • Must not have allergies to similar drugs as selinexor or temozolomide.
  • Must not have uncontrolled health issues.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
  • Patients with severe COVID-19 and certain risk factors should not receive selinexor.

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