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

University of Colorado, Denver8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Medulloblastoma High Risk Supratentorial PNET Metastatic PNET

Interventions

CarboplatinDRUG

Administered concurrently with craniospinal radiation.

VincristineDRUG

Administered concurrently with craniospinal radiation.

24 GyRADIATION

Craniospinal radiation.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Event-free Survival

MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.

Time frame: Up to 60 months.

Overall Survival

Overall Survival will be measured at the end of study. number of surviving participants is reported.

Time frame: 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.

Time frame: 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.

Time frame: Month 24

Intellectual Competence Measured by IQ Score: Month 60

Time frame: Month 60

Data from ClinicalTrials.gov

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