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Completed

NCT Number: NCT01542736

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

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.

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Key information

Conditions

Metastatic Medulloblastoma Glioma High Risk Supratentorial PNET Medulloblastoma Metastatic PNET Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive

Age range

3 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin

Drug

Administered concurrently with craniospinal radiation.

Vincristine

Drug

Administered concurrently with craniospinal radiation.

24 Gy

Radiation

Craniospinal radiation.

Primary outcomes

  1. Event-free Survival

    Time frame: Up to 60 months.

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

  2. Overall Survival

    Time frame: up to 5 years

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

  3. Intellectual Competence Measured by IQ Score: Week 8

    Time frame: 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.

  4. Intellectual Competence Measured by IQ Score: Month 24

    Time frame: 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.

  5. Intellectual Competence Measured by IQ Score: Month 60

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2012
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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