Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)

Study Overview
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Brief Summary
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The purpose of this study is to study the efficacy of the combination of reduced dose craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with concurrent carboplatin and vincristine administration for metastatic classical histology medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.

Official Title
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Feasibility of Using Concurrent Carboplatin and Reduced Dose Craniospinal Radiation (24Gy) for Metastatic Medulloblastoma, High-Risk Supratentorial PNET and Metastatic PNET

Conditions
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Metastatic Medulloblastoma, High Risk Supratentorial PNET, Metastatic PNET

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Vincristine
* Radiation: 24 Gy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 3 years and less than 25 years Patients with classic histology or desmoplastic histology metastatic medulloblastoma by histological diagnosis and by head and spine MRI. Patients with high-risk supratentorial, non-metastatic, PNET Patients with metastatic PNET Newly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decision Only patients who are expected to survive at least 6 weeks will be eligible for this study. Exclusion Criteria: Patients who are pregnant may not be treated on this study Patients with anaplastic histology

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced radiation with concurrent chemotherapy<br>Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration | Drug: Carboplatin<br>* Administered concurrently with craniospinal radiation.<br>Drug: Vincristine<br>* Administered concurrently with craniospinal radiation.<br>Radiation: 24 Gy<br>* Craniospinal radiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free Survival | MRIs of the head and spine. Number of participants with event free survival at 60 months is reported. | Up to 60 months. | 
| Overall Survival | Overall Survival will be measured at the end of study. number of surviving participants is reported. | up to 5 years | 
| Intellectual Competence Measured by IQ Score: Week 8 | Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. | Week 8 | 
| Intellectual Competence Measured by IQ Score: Month 24 | Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. | Month 24 | 
| Intellectual Competence Measured by IQ Score: Month 60 | Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. | Month 60 |