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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: February 27, 2012
Last updated: December 14, 2016
Last verified: December 2016
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.

Condition Intervention Phase
Metastatic Medulloblastoma High Risk Supratentorial PNET Metastatic PNET Drug: Carboplatin Drug: Vincristine Radiation: 24 Gy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Using Concurrent Carboplatin and Reduced Dose Craniospinal Radiation (24Gy) for Metastatic Medulloblastoma, High-Risk Supratentorial PNET and Metastatic PNET

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Event-free Survival [ Time Frame: up to 5 years ]
    MRIs of the head and spine

  • Overall Survival [ Time Frame: up to 5 years ]
  • Intellectual Competence measured by number of cognitive deficits [ Time Frame: up to 5 years ]
    Neuropsychological testing will be performed 3-6 months after radiation in completed.

Enrollment: 8
Study Start Date: May 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reduced radiation with concurrent chemotherapy
Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration
Drug: Carboplatin
Administered concurrently with craniospinal radiation.
Drug: Vincristine
Administered concurrently with craniospinal radiation.
Radiation: 24 Gy
Craniospinal radiation.


Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 anaplastic histology will be excluded.
  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01542736

United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Jennifer Madden, RN, CPNP University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT01542736     History of Changes
Other Study ID Numbers: 06-1151
Study First Received: February 27, 2012
Last Updated: December 14, 2016

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on June 26, 2017