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Molecular Characterization Trial for Childhood Brain Tumors and Neuroblastoma

This study, called a Molecular Characterization Trial (MCT), aims to better understand how radiation affects tumors and also causes side effects in children with certain cancers. It focuses on collecting biological samples and data from patients already enrolled in two specific trials: PNOC023 for diffuse midline glioma (a type of brain tumor) or COG ANBL1531 for high-risk neuroblastoma (a cancer that develops from immature nerve cells). If you are on PNOC023, you would receive standard external beam radiotherapy. If you are on COG ANBL1531, you would receive 131I-Metaiodobenzylguanidine (MIBG), a radioactive medicine, through an IV. The researchers will look at how long patients live without their cancer returning (event-free survival) by studying differences within tumors, how cells repair DNA damage, and changes in tumor DNA over up to three years. The study is currently unclear about its recruitment status and plans to enroll 47 participants.

Study design
This is an interventional study, meaning participants receive specific treatments. It plans to enroll 47 participants.
What's involved
You would be enrolled in one of two other clinical trials (PNOC023 or COG ANBL1531) and would have biological samples collected before, during, and after radiation treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will track event-free survival for up to 3 years after treatment.

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NCT06000787

MCT for the Harvard/UCSF ROBIN Center

Recruiting
NAAll AgesInterventionalBasic science
Brigham and Women's Hospital
~47 participants
Updated 2025-02-17 on ClinicalTrials.gov
What's tested:External beam radiotherapy131I-Metaiodobenzylguanidine (MIBG)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free survival by tumor heterogeneity
Measured over up to 3 years
+2 more outcomes measured

Conditions

Glioma, Childhood Brainstem
Neuroblastoma

Explore related trials

Brain NeoplasmDiffuse Midline GliomaNeuroblastoma

Where it's being run

2 sites across 2 states
California1
Massachusetts1

Study leadership

  • David Kozono, MD, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

David Kozono, MD, PhD
[email protected]
617-582-8237
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Enrollment on one of the following clinical trials:
Pacific Pediatric Neuro-Oncology Consortium PNOC023: 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 Brain Tumors (NCT04732065) - Arm A or B (Key Eligibility Criteria: Newly diagnosed DMG, Age ≥ 2 years, If on corticosteroids, on a stable or decreasing dose for ≥ 3 days prior to baseline MRI scan, Karnofsky ≥ 50 for age \>16 or Lansky ≥ 50 for age ≤ 16, No known disorder that affects the immune system or uncontrolled infection)
Children's Oncology Group ANBL1531: A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NCT03126916) - Arm B (Key Eligibility Criteria: Diagnosis of high-risk neuroblastoma (INRG Stage M with MYCN amplification or age \> 547 days, INRG Stage MS with MYCN amplification, INRG Stage L2 with MYCN amplification, or progression to Stage M in certain groups), Age ≥ 1 and ≤ 30 years at diagnosis, No prior systemic or radiation therapy, with certain exceptions, No contraindication to targeted radiopharmaceutical therapy)
Tumor tissue confirmation of malignancy
Adequate bone marrow, renal, liver and neurologic function
Availability of tumor tissue, blood and/or CSF biospecimens

Exclusion

Pregnancy or breastfeeding
Inability to follow the procedures of the study

What this trial measures

  • Event-free survival by tumor heterogeneityup to 3 years

    EFS is calculated from the date of treatment assignment to the first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred. This will be compared in participants with tumors showing high versus low tumor heterogeneity assessed quantitatively based on single-cell RNA sequencing.

  • Event-free survival by DNA damage responseup to 3 years

    EFS is calculated from the date of treatment assignment to the first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred. This will be compared in participants with tumors showing intact versus defective responses to treatment-induced DNA damage determined by immunohistochemistry and microRNA profiling.

  • Event-free survival by tumor DNA alterationsup to 3 years

    EFS is calculated from the date of treatment assignment to the first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred. This will be compared in participants with tumors showing presence or absence of point mutations and copy number alterations detected in tumor tissue or circulating cell-free DNA.