MCT for the Harvard/UCSF ROBIN Center
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or breastfeeding
Inability to follow the procedures of the study
Trial design
Design model
Parallel
Treatments tested in this trial
External beam radiotherapy
RadiationSubjects 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)
RadiationSubjects 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.
Treatment groups
47 Participants
are divided into 2 treatment groupsGroup A: Diffuse Midline GliomaOther 1 intervention
Group B: NeuroblastomaOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 3 years2
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.
Time frame
up to 3 years3
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.
Time frame
up to 3 yearsSecondary outcomes
1
Proportion of patients with serious adverse events by DNA damage response
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.
Time frame
up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Dana-Farber Cancer Institute
Collaborator
National Cancer Institute (NCI)
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov