Study of Selinexor and Radiation Therapy for Newly Diagnosed Brain Tumors in Children and Young Adults

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05099003

Provider View

This clinical trial is testing the safety and effectiveness of combining the drug selinexor with radiation therapy to treat children and young adults with newly diagnosed brain tumors called diffuse intrinsic pontine glioma (DIPG) and high-grade glioma (HGG).

Patient Parameters

Program Overview

This study aims to find out if the drug selinexor, when used with radiation therapy, is safe and can help shrink tumors in children and young adults with newly diagnosed brain tumors known as DIPG and HGG. These tumors are aggressive and grow quickly. The trial has two parts: the first part determines the safest dose of selinexor, and the second part tests how well this dose works against the tumors. Selinexor works by blocking a protein that helps cancer cells grow, while radiation therapy uses high energy to kill cancer cells.

Description

The study is divided into two phases. In the first phase, researchers will determine the safest dose of selinexor that can be given with radiation therapy without causing severe side effects. This is called the Dose-Finding Phase. In the second phase, known as the Efficacy Phase, researchers will test how well this dose works in shrinking the tumors.

Participants will receive standard radiation therapy five days a week for 5-7 weeks. Starting on the fourth or fifth day of radiation, they will take selinexor by mouth on specific days. After a two-week break, they will continue taking selinexor every week for up to 24 cycles, as long as the cancer does not progress and side effects are manageable. Regular MRI scans will be done to monitor the tumors.

After completing the treatment, participants will have follow-up visits every three months in the first year, every six months in the second and third years, and once a year in the fourth and fifth years.

Eligibility Criteria

Inclusion Criteria

  • Must be 25 years old or younger at the time of enrollment.
  • Must have a newly diagnosed brain tumor called DIPG or HGG.
  • Must have a performance status that allows for normal activities or minor restrictions.
  • Must have adequate blood counts and organ function based on specific medical tests.
  • Must not have received any prior treatment for the brain tumor except surgery and steroids.
  • Must be able to start treatment within 31 days of diagnosis or surgery.
  • Must agree to use effective birth control methods if of childbearing potential.

Exclusion Criteria

  • Must not have received any prior therapy for the brain tumor except surgery and steroids.
  • Must not be currently taking any other investigational drugs or anti-cancer agents.
  • Must not have an uncontrolled infection or have received a prior organ transplant.
  • Must not have certain eye conditions or movement disorders.
  • Must not have metastatic disease or certain types of brain tumors.
  • Must not be pregnant or breastfeeding, and must agree to use birth control if of childbearing potential.

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