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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542736
First Posted: March 2, 2012
Last Update Posted: September 21, 2017
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.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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 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: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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

  • 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.

  • 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.


Enrollment: 8
Study Start Date: May 2007
Study Completion Date: November 2015
Primary Completion Date: November 2015 (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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01542736


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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01542736     History of Changes
Other Study ID Numbers: 06-1151
First Submitted: February 27, 2012
First Posted: March 2, 2012
Last Update Posted: September 21, 2017
Last Verified: September 2017

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