Targeted Pediatric High-Grade Glioma Therapy
Molecularly-Guided Phase II Umbrella Trial for Children, Adolescents, and Young Adults Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma
2 other identifiers
observational
350
7 countries
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedStudy Start
First participant enrolled
August 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 28, 2034
March 31, 2026
September 1, 2025
5.1 years
April 20, 2023
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Molecular profiling
Utilize molecular, clinical, and histopathologic data to assess eligibility for specific biologically-guided treatment subprotocols among pediatric, adolescent and young adult patients with newly diagnosed HGG, including DIPG.
4 years
Feasibility of molecular profiling and enrollment to a TarGeT treatment protocol
Determine the percent of pediatric, adolescent, and young adult patients newly diagnosed with HGG, including DIPG, who undergo screening through one of three TarGeT-SCR screening mechanisms and are assigned to a TarGeT treatment arm.
4 years
Secondary Outcomes (7)
Genomic Research
6 years
Germline susceptibility testing
4 years
Biobanking
4 years
Progression Free Survival
4 years
Feasibility of Assignment
4 years
- +2 more secondary outcomes
Eligibility Criteria
Pediatric and young adult patients new diagnosed with High Grade Glioma including Diffuse Intrinsic Pontine Glioma (per 2021 WHO CNS tumor classification)
You may qualify if:
- Age: Patients must be ≥12 months and ≤39 years of age at the time of enrollment onto this screening protocol.
- Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. Diagnosis must have histologic confirmation from biopsy or resection. The diagnosis of HGG must have been confirmed by pathology review at the local site. 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.
- 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.
- Prior Therapy for HGG: Surgery, radiation, and/or dexamethasone are permissible. Temozolomide concurrent with radiation is permissible. Prior administration of avastin/bevacizumab is allowed (individual treatment arms have different washout period requirements, check individual arm eligibility). No other prior anticancer therapy for HGG will be allowed.
- Participants screening for assignment to TarGeT-L may not have received radiation.
- Timing from surgery to start of RT: For patients who have started RT, radiation must have started \<42 days from definitive surgery or biopsy, however it is strongly recommended patients start RT within 31 days from definitive surgery (if patient had two surgeries, radiation must have started within 31 days from second surgery).
- 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, saliva, or buccal swab) 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.
- 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.
- Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between diagnosis and the following specific timepoints post completion of RT (if relevant)
- +10 more criteria
You may not qualify if:
- Tumors that do not meet HGG and DIPG diagnoses specified above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., 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
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, 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
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
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
Queensland Children's Hospital
South Brisbane, Queensland, 4101, Australia
Royal Children's Hospital
Melbourne, Victoria, 3052, Australia
Perth Children's Hospital
Perth, Western Australia, 6000, Australia
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G1X8, Canada
Montreal Children's Hospital
Montreal, Quebec, H4A3J1, Canada
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)
Heidelberg, Baden-Wurttemberg, 69120, Germany
Princess Máxima Center
Utrecht, 3720, Netherlands
Starship Children's Hospital
Auckland, Grafton, 1023, New Zealand
Great Ormond Street Hospital
London, WC1N 3JH, United Kingdom
Biospecimen
Brain tumor samples with matched normal comparator (blood preferred alternatively, saliva or buccal swab)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maryam Fouladi, MD
Nationwide Children's Hospital
- STUDY DIRECTOR
Margot Lazow, MD
Nationwide Children's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2023
First Posted
May 3, 2023
Study Start
August 2, 2024
Primary Completion (Estimated)
August 28, 2029
Study Completion (Estimated)
August 28, 2034
Last Updated
March 31, 2026
Record last verified: 2025-09