Molecular Characterization Trial for the Harvard/UCSF ROBIN Center: Radiation Oncology at the Interface of Pediatric Cancer Biology and Data Science
Brigham and Women's Hospital
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.
Description
The MCT is critical to testing the central hypothesis of the Harvard/UCSF ROBIN and achieving the central goals of the Center. This hypothesis centers on recent observations that cells within a single tumor show tremendous variability from a developmental and biological perspective. This contrasts with how radiation oncologists usually approach individual tumors as they plan the radiotherapy course: generally, the entire tumor is targeted with a uniform dose of radiation albeit with efforts to keep doses to adjacent normal tissues as low as possible. The Harvard/UCSF ROBIN Center proposes to t…
Eligibility
- Age range
- Not specified
- Sex
- All
- 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 a…
Interventions
- RadiationExternal 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.
- Radiation131I-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.
Locations (2)
- University of California, San FranciscoSan Francisco, California
- Brigham and Women's HospitalBoston, Massachusetts