Status:
RECRUITING
MCT for the Harvard/UCSF ROBIN Center
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Conditions:
Glioma, Childhood Brainstem
Neuroblastoma
Eligibility:
All Genders
Phase:
NA
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 a...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- Pregnancy or breastfeeding
- Inability to follow the procedures of the study
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06000787
Start Date
September 19 2023
End Date
August 31 2028
Last Update
February 17 2025
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115