Study on Ribociclib and Everolimus for Treating High-Grade Glioma and DIPG in Children and Young Adults

Sponsor: Nationwide Children's Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05843253

Provider View

This clinical trial is testing whether the combination of two drugs, ribociclib and everolimus, can help extend the lives of children and young adults newly diagnosed with high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) that have specific genetic changes.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drugs ribociclib and everolimus can effectively treat children and young adults with newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). These tumors have specific genetic changes that the drugs target. The study will look at whether this combination can help patients live longer.

Description

This international study is testing the combination of ribociclib and everolimus after radiation therapy in children, adolescents, and young adults with newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). The study will first determine the safe dose of ribociclib in combination with everolimus. Then, it will evaluate how well the treatment works by looking at how long patients live without the cancer getting worse and overall survival rates. The study will also assess how the treatment affects the tumors and any side effects. Patients will start the treatment within 35 days after finishing radiation therapy, and the treatment will last up to 26 cycles, with each cycle being 28 days long. Ribociclib is taken orally for 3 weeks with a week off, and everolimus is taken daily.

Eligibility Criteria

Inclusion Criteria

  • Age between 12 months and 39 years old.
  • Newly diagnosed with high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).
  • Must have tumor tissue from a biopsy or surgery.
  • Tumors must have specific genetic changes that the drugs target.
  • Good overall health with a performance score of 50% or higher.
  • Must have received radiation therapy within 31 days of diagnosis.
  • Adequate blood cell counts and organ function.
  • Must agree to use effective contraception if of childbearing potential.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Currently taking other investigational drugs or anti-cancer agents, except for specific cases.
  • Taking medications that affect the heart's rhythm or certain enzymes.
  • Have uncontrolled infections or significant medical or psychiatric conditions that could affect safety or study results.
  • Have conditions that affect drug absorption.

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