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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01542736
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : September 21, 2017
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2007
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Event-free Survival [ Time Frame: Pre-study, then post XRT MRI at week 10 and 4, 6, 8, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60 months. ]
    MRIs of the head and spine

  2. Overall Survival [ Time Frame: up to 5 years ]
    Overall Survival will be measured as "time of death from any cause" and will be 'assessed' at every time point and then at the end of study.

  3. Intellectual Competence measured by number of cognitive deficits [ Time Frame: Week 8; 24 and 60 months post XRT Treatment ]
    Neuropsychological testing will be performed 3-6 months after radiation in completed.

Information from the National Library of Medicine

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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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01542736

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

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Responsible Party: University of Colorado, Denver Identifier: NCT01542736     History of Changes
Other Study ID Numbers: 06-1151
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

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