RecruitingPhase 1NCT04323046

Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults

A Single Arm, Pilot of Neoadjuvant Checkpoint Inhibition Followed by Adjuvant Checkpoint Inhibition in Children and Young Adults With Recurrent or Progressive High Grade Glioma (HGG)

Sponsor

Sabine Mueller, MD, PhD

Enrollment

20 participants

Start Date

Oct 2, 2020

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Malignant Glioma Recurrent Glioblastoma Grade III Glioma Recurrent Malignant Glioma Recurrent Grade III Glioma

Summary

This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Eligibility

Min Age: 6 MonthsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy (a treatment that activates the immune system to fight cancer) both before and after surgery can help children and young adults whose aggressive brain tumor (high-grade glioma) has come back or continued to grow after initial treatment. **You may be eligible if...** - You are older than 6 months and younger than 25 years old - Your high-grade brain tumor (grade III or IV glioma) has come back or kept growing after previous radiation and/or chemotherapy - You are a candidate for surgery to remove or reduce the tumor - You are well enough to participate (able to perform basic self-care activities) - You and your guardian have provided written consent **You may NOT be eligible if...** - You have not previously been treated for your brain tumor - You are too unwell physically to undergo surgery - The goal of your surgery would only be a biopsy (not tumor reduction) - You do not meet the blood and organ function requirements 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

BIOLOGICALNivolumab

Given IV

OTHERQuality-of-Life Assessment

Ancillary studies, given in person or online

OTHERQuestionnaire Administration

Ancillary studies, given in person or online

Locations(20)

University of Alabama at Birmingham, Children's of Alabama

Birmingham, Alabama, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Rady Children's Hospital

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

Children's National Hospital

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

University of Florida

Gainesville, Florida, United States

Riley Children's Hospital

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University St. Louis

St Louis, Missouri, United States

Hackensack Meridian Children's Health at Joseph M. Sanzari Children's Hospital

Hackensack, New Jersey, United States

Duke Children's Hospital & Health Center

Durham, North Carolina, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Utah

Salt Lake City, Utah, United States

Sydney Children's Hospital

Sydney, New South Wales, Australia

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Royal Children's Hospital

Parkville, Victoria, Australia

Perth Children's' Hospital

Perth, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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

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NCT04323046

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