RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.

Official Title

Molecularly-Guided Phase II Umbrella Trial for Children, Adolescents, and Young Adults Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma

Quick Facts

Study Start:2024-08-02

Study Completion:2034-08-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05839379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Age: Patients must be ≥12 months and ≤30 years of age at the time of enrollment onto this screening protocol. 2. Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. The diagnosis of HGG must have been confirmed by local pathology review. for the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (eg, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma). For all other tumors, histologic grade must be WHO grade 3-4. 3. Disease Status: There are no disease status requirements for enrollment. * Measurable disease is not required. Patients without measurable disease are eligible. * Patients with metastatic/disseminated or multifocal disease or gliomatosis cerebri are eligible. * Patients with a primary spinal tumor are eligible. * Patients with secondary, radiation related HGG are eligible. 4. Prior Therapy for HGG: Surgery, radiation, and/or dexamethasone are permissible. Temozolomide concurrent with radiation is permissible, but not recommended. No other prior anticancer therapy for HGG will be allowed. 5. Tumor Sample Availability OR results from previous molecular profiling/targeted sequencing * If a patient screens through OPTION #1, tumor sample in addition to normal comparator tissue (peripheral blood or saliva) must be submitted for comprehensive molecular screening at the time of screening enrollment. * If a patient screens through OPTIONS #2 or #3, results from previously performed molecular profiling must be submitted following enrollment. It is highly recommended that results be uploaded within 7 days of enrollment (if results are available at time of enrollment) or within 7 days of results becoming available (if pending at time of enrollment) to allow adequate time for central review. 6. Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines. 7. Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between diagnosis and the following specific timepoints post completion of RT * Patients screening through OPTION #1 are eligible to enroll anytime between diagnosis and 10 days post RT. * Patients screening through OPTIONS #2 or #3 are eligible to enroll anytime between diagnosis and 21 days post RT. * For treatment protocols that include targeted therapy administered concurrently with RT, patients must start treatment within 10 calendar days of starting RT. * For treatment protocols that only include maintenance/adjuvant therapy (no systemic therapy given concurrently with radiation), patients must start treatment by 35 days post RT * OPTION1: Molecular screening through CONNECT TarGeT Clinical Testing Laboratories * OPTION2: Molecular screening through a national comprehensive tumor profiling program * OPTION3: Clinically validated targeted sequencing or focused profiling	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Age: Patients must be ≥12 months and ≤30 years of age at the time of enrollment onto this screening protocol.
2. Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. The diagnosis of HGG must have been confirmed by local pathology review. for the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (eg, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma). For all other tumors, histologic grade must be WHO grade 3-4.
3. Disease Status: There are no disease status requirements for enrollment.
* Measurable disease is not required. Patients without measurable disease are eligible.
* Patients with metastatic/disseminated or multifocal disease or gliomatosis cerebri are eligible.
* Patients with a primary spinal tumor are eligible.
* Patients with secondary, radiation related HGG are eligible.
4. Prior Therapy for HGG: Surgery, radiation, and/or dexamethasone are permissible. Temozolomide concurrent with radiation is permissible, but not recommended. No other prior anticancer therapy for HGG will be allowed.
5. Tumor Sample Availability OR results from previous molecular profiling/targeted sequencing
* If a patient screens through OPTION #1, tumor sample in addition to normal comparator tissue (peripheral blood or saliva) must be submitted for comprehensive molecular screening at the time of screening enrollment.
* If a patient screens through OPTIONS #2 or #3, results from previously performed molecular profiling must be submitted following enrollment. It is highly recommended that results be uploaded within 7 days of enrollment (if results are available at time of enrollment) or within 7 days of results becoming available (if pending at time of enrollment) to allow adequate time for central review.
6. Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
7. Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between diagnosis and the following specific timepoints post completion of RT
* Patients screening through OPTION #1 are eligible to enroll anytime between diagnosis and 10 days post RT.
* Patients screening through OPTIONS #2 or #3 are eligible to enroll anytime between diagnosis and 21 days post RT.
* For treatment protocols that include targeted therapy administered concurrently with RT, patients must start treatment within 10 calendar days of starting RT.
* For treatment protocols that only include maintenance/adjuvant therapy (no systemic therapy given concurrently with radiation), patients must start treatment by 35 days post RT
* OPTION1: Molecular screening through CONNECT TarGeT Clinical Testing Laboratories
* OPTION2: Molecular screening through a national comprehensive tumor profiling program
* OPTION3: Clinically validated targeted sequencing or focused profiling

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Amy K Jones, MSN

CONTACT

16147223284

Target@nationwidechildrens.org

Principal Investigator

Maryam Fouladi, MD

STUDY_CHAIR

Nationwide Children's Hospital

Margot Lazow, MD

STUDY_DIRECTOR

Nationwide Children's Hospital

Study Locations (Sites)

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Children's National Medical Center

Washington, District of Columbia, 20010

United States

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

Chicago, Illinois, 60611

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Duke University Health System

Durham, North Carolina, 27708

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Texas Children's Hospital

Houston, Texas, 77030

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

Maryam Fouladi, MD, STUDY_CHAIR, Nationwide Children's Hospital
Margot Lazow, MD, STUDY_DIRECTOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-02

Study Completion Date2034-08-28

Study Record Updates

Study Start Date2024-08-02

Study Completion Date2034-08-28

Terms related to this study

Additional Relevant MeSH Terms

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