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Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and PNET

This study is currently recruiting participants.
Verified February 2012 by Children's Hospital Colorado
Sponsor:
Information provided by (Responsible Party):
Jennifer Madden, Children's Hospital Colorad
ClinicalTrials.gov Identifier:
NCT01542736
First received: February 27, 2012
Last updated: March 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Children's Hospital Colorado:

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

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


Estimated Enrollment: 10
Study Start Date: May 2007
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration
 Drug: Carboplatin Drug: Vincristine Radiation: 24 Gy

  Eligibility

Ages Eligible for Study:   3 Years to 25 Years
Genders Eligible for Study:   Both
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542736

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jennifer Madden, CPNP     720-777-6772     Jennifer.Madden@childrenscolorado.org    
Principal Investigator: Jennifer Madden, RN, CPNP            
Sponsors and Collaborators
Children's Hospital Colorado
  More Information

No publications provided

Responsible Party: Jennifer Madden, Pediatric Nurse Practitioner, NeuroOncology, Assistant Professor, Children's Hospital Colorad
ClinicalTrials.gov Identifier: NCT01542736     History of Changes
Other Study ID Numbers: COMIRB 06-1151
Study First Received: February 27, 2012
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 17, 2012