RecruitingPhase 1NCT06894979

Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD1390 (NSC# 852149) When Combined With Focal Radiation in Pediatric Patients With High Grade Glioma

Sponsor

Children's Oncology Group

Enrollment

54 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Childhood Astrocytoma Childhood Diffuse Intrinsic Pontine Glioma Childhood Diffuse Midline Glioma Childhood Glioblastoma Childhood Malignant Glioma

Summary

This phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma. AZD1390 is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving AZD1390 with radiation may be safe, tolerable, and/or effective in treating pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma.

Eligibility

Min Age: 12 MonthsMax Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a new drug called AZD1390 to standard radiation therapy helps treat aggressive brain tumors in children and young adults. Researchers want to see if this combination is safe and more effective than radiation alone for newly diagnosed high-grade gliomas, diffuse midline gliomas, or a type of brainstem tumor called DIPG. **You may be eligible if...** - You are at least 12 months and under 18 years old (dose escalation phase) or under 22 years old (expansion phase) - You have been newly diagnosed with a high-grade glioma, diffuse midline glioma, or DIPG - Your tumor is eligible for standard fractionated radiation therapy - You have adequate organ function (kidney, liver, heart, blood counts) - You have not previously received radiation to the brain or spine **You may NOT be eligible if...** - You have already received radiation to the brain or spine - You have a spinal primary tumor - You are pregnant or breastfeeding - You have certain genetic conditions (like Fanconi anemia) that affect DNA repair - You cannot swallow pills or capsules - You are currently on certain medications that interact with AZD1390 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

DRUGATM Kinase Inhibitor AZD1390

Given PO

PROCEDUREBiospecimen Collection

Undergo blood and cerebrospinal fluid collection

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

RADIATIONRadiation Therapy

Undergo radiation therapy

OTHERSurvey Administration

Ancillary studies

Locations(17)

Children's Hospital of Alabama

Birmingham, Alabama, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center

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

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

UMC Cancer Center / UMC Health System

Lubbock, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06894979