MCT for the Harvard/UCSF ROBIN Center

NCT06000787 | Recruiting FDA Device

• 2 other identifiers: 2023P002087U54CA274516
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Event-free survival by tumor heterogeneity

  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.

  up to 3 years

• Event-free survival by DNA damage response

  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.

  up to 3 years

• Event-free survival by tumor DNA alterations

  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.

  up to 3 years

Secondary Outcomes (1)

• Proportion of patients with serious adverse events by DNA damage response

  up to 18 months

Study Arms (2)

Diffuse Midline Glioma

OTHER

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

Radiation: External beam radiotherapy

Neuroblastoma

OTHER

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

Radiation: 131I-Metaiodobenzylguanidine (MIBG)

Interventions

External beam radiotherapy RADIATION

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

Diffuse Midline Glioma

131I-Metaiodobenzylguanidine (MIBG) RADIATION

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.

Neuroblastoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• National Cancer Institute (NCI): collaborator
• University of California, San Francisco: collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Glioma; Neuroblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive

Study Officials

• David Kozono, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Kozono, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Model Details: Two non-randomized cohorts with assignment based on tumor type

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 21, 2023
• Study Start: September 19, 2023
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)