Recruiting

Molecular Characterization

Sponsor:

Brigham and Women's Hospital

Code:

NCT06000787

Conditions

Glioma, Childhood Brainstem

Neuroblastoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

External beam radiotherapy

131I-Metaiodobenzylguanidine (MIBG)

Study Details

Brief summary:

The goal of the Molecular Characterization Trial (MCT) is to obtain biological specimens and data resources from patients enrolled on prospective trials, to ensure that the Harvard/UCSF ROBIN Center accomplishes its key objective of advancing our understanding of the biological mechanisms that underlie how radiation treats tumors but also can cause unwanted side effects. The MCT focuses on collection of research biospecimens before, during, and after radiation. Also critical to the MCT is the deep annotation of these research biospecimens with elements that complement each other to provide a holistic, detailed view of each patient. Annotated elements include those used in the past such as clinical and biological features but extend to factors we have so far neglected but must incorporate in the future such as dosimetry (precise anatomical measurement of radiation dose), artificial intelligence, computational biology, and natural language processing.

Conditions

Glioma, Childhood Brainstem

Neuroblastoma

Study ID

NCT06000787

Start date

Sep 19, 2023

Status verified date

Jan, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • Pregnancy or breastfeeding
  • Inability to follow the procedures of the study

Study Design

Enrollment

47 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Diffuse Midline Glioma

Subjects with diffuse midline glioma on PNOC023 (NCT04732065) Arm A or B

other: Neuroblastoma

Subjects with high-risk neuroblastoma on COG ANBL1531 (NCT03126916) Arm B

Interventions

External beam radiotherapy

Subjects with diffuse midline glioma on PNOC023 (NCT04732065) Arm A or B receive standard-of-care external beam radiotherapy to the brain tumor.

131I-Metaiodobenzylguanidine (MIBG)

Subjects with high-risk neuroblastoma on COG ANBL1531 (NCT03126916) Arm B receive the radiopharmaceutical 131I-Metaiodobenzylguanidine (MIBG) 15 mCi/kg via either a central or a peripheral IV catheter over 1.5 to 2 hours at a maximum rate of 500 mCi/hour.

Primary outcome measure

  • Event-free survival by tumor heterogeneity [ Time Frame: up to 3 years ]
  • Event-free survival by DNA damage response [ Time Frame: up to 3 years ]
  • Event-free survival by tumor DNA alterations [ Time Frame: up to 3 years ]

Central Contacts and Locations

Central contacts

David Kozono, MD, PhD

617-582-8237dkozono@bwh.harvard.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

David Kozono, MD, PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 17, 2025

Last verified

Jan, 2025

Keywords

  • Diffuse midline glioma
  • Iodine-131 meta-iodobenzylguanidine
  • Radiation oncology
  • Radiobiology
  • Radiopharmaceutical
  • Radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-02-17.