MCT for the Harvard/UCSF ROBIN Center
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06000787 |
Recruitment Status :
Recruiting
First Posted : August 21, 2023
Last Update Posted : December 12, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioma, Childhood Brainstem Neuroblastoma | Radiation: External beam radiotherapy Radiation: 131I-Metaiodobenzylguanidine (MIBG) | Not Applicable |
![Show](/ct2/html/images/expand.png)
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 47 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Two non-randomized cohorts with assignment based on tumor type |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Molecular Characterization Trial for the Harvard/UCSF ROBIN Center: Radiation Oncology at the Interface of Pediatric Cancer Biology and Data Science |
Actual Study Start Date : | September 19, 2023 |
Estimated Primary Completion Date : | August 31, 2028 |
Estimated Study Completion Date : | August 31, 2028 |
![](/ct2/html/images/NIH_NLM_ABRV_BLK_4.png)
Arm | Intervention/treatment |
---|---|
Diffuse Midline Glioma
Subjects with diffuse midline glioma on PNOC023 (NCT04732065) Arm A or B
|
Radiation: 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. |
Neuroblastoma
Subjects with high-risk neuroblastoma on COG ANBL1531 (NCT03126916) Arm B
|
Radiation: 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. |
- Event-free survival by tumor heterogeneity [ Time Frame: up 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 response [ Time Frame: up 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 alterations [ Time Frame: up 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.
- Proportion of patients with serious adverse events by DNA damage response [ Time Frame: up to 18 months ]Serious adverse events will be defined as one or more Grade 3 or higher toxicities during protocol therapy graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, or meeting protocol-specified criteria for dose-limiting toxicities. This will be compared in participants with blood samples showing intact versus defective responses to treatment-induced DNA damage determined by immunohistochemistry and microRNA profiling.
![](/ct2/html/images/NIH_NLM_ABRV_BLK_4.png)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
![](/ct2/html/images/NIH_NLM_ABRV_BLK_4.png)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06000787
Contact: David Kozono, MD, PhD | 617-582-8237 | dkozono@bwh.harvard.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Sabine Mueller, MD, PhD | |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: David Kozono, MD, PhD | |
Principal Investigator: David Kozono, MD, PhD |
Principal Investigator: | David Kozono, MD, PhD | Brigham and Women's Hospital |
Responsible Party: | David E. Kozono, Assistant Professor of Radiation Oncology, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT06000787 |
Other Study ID Numbers: |
2023P002087 U54CA274516 ( U.S. NIH Grant/Contract ) |
First Posted: | August 21, 2023 Key Record Dates |
Last Update Posted: | December 12, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Diffuse midline glioma Iodine-131 meta-iodobenzylguanidine Radiation oncology |
Radiobiology Radiopharmaceutical Radiotherapy |
Neuroblastoma 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 3-Iodobenzylguanidine Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Radiopharmaceuticals |