RecruitingPhase 2NCT05843253

Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG/DIPG Which Harbor Alterations of the Cell Cycle and/or PI3K/mTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant

Sponsor

Nationwide Children's Hospital

Enrollment

120 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Brain Tumor Glioblastoma Glioblastoma Multiforme High Grade Glioma Diffuse Intrinsic Pontine Glioma Anaplastic Astrocytoma WHO Grade III Glioma WHO Grade IV Glioma Diffuse Midline Glioma, H3 K27M-Mutant Diffuse Hemispheric Glioma, H3 G34-Mutant

Summary

The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant. The main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG/DIPG or DHG H3G34-mutant.

Eligibility

Min Age: 12 MonthsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This pediatric study tests two drug combinations for children and young people with high-grade brain tumors: ribociclib plus everolimus for high-grade glioma (HGG) and DIPG (a tumor in the brainstem), and ribociclib plus temozolomide for a specific brain tumor type with an H3G34 genetic mutation. These combinations target growth pathways that drive these aggressive tumors. **You may be eligible if...** - You are under 21 years old (for the initial phase) or meet the age criteria for one of the specific study groups - You have a newly diagnosed or recurrent high-grade brain tumor that fits one of the study categories (HGG, DIPG, or H3G34-mutant diffuse hemispheric glioma) - You are in good enough health to receive study treatment **You may NOT be eligible if...** - Your tumor does not fit the molecular or anatomical criteria for any study arm - You have received prior CDK4/6 inhibitor treatment (a class of targeted therapy) - You have serious uncontrolled heart, liver, or other organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRibociclib

Ribociclib PO qd on days 1-21

DRUGEverolimus

Everolimus PO qd on days 1-28

DRUGTemozolomide (TMZ)

Temozolomide PO qd on days 1-5 for the first 13 cycles

Locations(21)

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Duke University Health System

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Sydney Children's Hospital

Randwick, New South Wales, Australia

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Royal Children's Hospital

Melbourne, Victoria, Australia

Perth Children's Hospital

Perth, Western Australia, Australia

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)

Heidelberg, Baden-Wurttemberg, Germany

Princess Máxima Center

Utrecht, Netherlands

Starship Children's Hospital

Auckland, Grafton, New Zealand

Great Ormond Street Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05843253

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