RecruitingPhase 1NCT04732065

ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors

Open Label Phase 1 and Target Validation Study of ONC206 in Children and Young Adults With Newly Diagnosed or Recurrent Diffuse Midline Glioma (DMG), and Other Recurrent Primary Malignant Central Nervous System (CNS) Tumors


Sponsor

Sabine Mueller, MD, PhD

Enrollment

208 participants

Start Date

Aug 23, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called "stress response" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.


Eligibility

Min Age: 2 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This trial tests an experimental drug called ONC206 for children and young adults with a rare and aggressive brain tumor called diffuse midline glioma (DMG), as well as other hard-to-treat brain and spinal cord cancers that have come back after prior treatment. **You may be eligible if...** - You are 2 years of age or older (some parts of the study require age 2–21) - You have been diagnosed with DMG with a specific genetic change (H3K27 alteration) and completed at least one prior treatment including radiation - OR you have another type of recurrent brain or spinal cord tumor that has not responded to standard treatments - You completed radiation 4–14 weeks before enrolling **You may NOT be eligible if...** - You have not yet completed radiation therapy or started other post-radiation treatments - You have significant organ problems or active serious infections - Your tumor is not in the brain or spinal cord 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

DRUGONC206

Given orally (PO)

RADIATIONStandard of Care Radiation Therapy

Undergo RT

PROCEDUREOptional Proton (1H) MR spectroscopy (MRS)

Optional imaging procedure


Locations(6)

University of California, San Francisco

San Francisco, California, United States

Emory University

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Princess Máxima Center for Pediatric Oncology

Utrecht, Netherlands

The University Children's Hospital in Zurich

Zurich, Canton of Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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

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NCT04732065


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