Molecular Characterization of Pediatric Brain Tumors and Neuroblastoma
Molecular Characterization Trial for the Harvard/UCSF ROBIN Center: Radiation Oncology at the Interface of Pediatric Cancer Biology and Data Science
This study is trying to understand how radiation treatment affects brain tumors and neuroblastoma in kids by collecting samples and data from patients to see how their tumors behave and respond to treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | Crizotinib, radiation |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT06000787 on ClinicalTrials.gov |
What this trial studies
This trial aims to collect biological specimens and data from pediatric patients undergoing radiation treatment for gliomas and neuroblastoma. It focuses on understanding the biological mechanisms of how radiation affects tumors and the potential side effects it may cause. By utilizing advanced technologies for deep molecular analysis, the study seeks to explore the variability within tumors and how this impacts treatment responses. The research will involve detailed annotation of biospecimens, incorporating clinical, biological, and new technological factors to provide a comprehensive view of each patient's tumor biology.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with diffuse midline glioma or high-risk neuroblastoma who are enrolled in specific clinical trials.
Not a fit: Patients with tumors that do not fall under the specified conditions or those not enrolled in the associated clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective radiation therapies for pediatric cancer patients.
How similar studies have performed: Other studies have shown promise in utilizing molecular characterization approaches in cancer treatment, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California and 1 other locations
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: David Kozono, MD, PhD — Brigham and Women's Hospital
- Study coordinator: David Kozono, MD, PhD
- Email: dkozono@bwh.harvard.edu
- Phone: 617-582-8237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.