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

Primary Purpose

Metastatic Medulloblastoma, High Risk Supratentorial PNET, Metastatic PNET

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Vincristine
24 Gy
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Medulloblastoma

Eligibility Criteria

3 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reduced radiation with concurrent chemotherapy

Arm Description

Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration

Outcomes

Primary Outcome Measures

Event-free Survival
MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.
Overall Survival
Overall Survival will be measured at the end of study. number of surviving participants is reported.
Intellectual Competence Measured by IQ Score: 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.
Intellectual Competence Measured by IQ Score: 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.
Intellectual Competence Measured by IQ Score: 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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2012
Last Updated
December 13, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01542736
Brief Title
Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)
Official Title
Feasibility of Using Concurrent Carboplatin and Reduced Dose Craniospinal Radiation (24Gy) for Metastatic Medulloblastoma, High-Risk Supratentorial PNET and Metastatic PNET
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Medulloblastoma, High Risk Supratentorial PNET, Metastatic PNET

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced radiation with concurrent chemotherapy
Arm Type
Experimental
Arm Description
Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Administered concurrently with craniospinal radiation.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Administered concurrently with craniospinal radiation.
Intervention Type
Radiation
Intervention Name(s)
24 Gy
Intervention Description
Craniospinal radiation.
Primary Outcome Measure Information:
Title
Event-free Survival
Description
MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.
Time Frame
Up to 60 months.
Title
Overall Survival
Description
Overall Survival will be measured at the end of study. number of surviving participants is reported.
Time Frame
up to 5 years
Title
Intellectual Competence Measured by IQ Score: Week 8
Description
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.
Time Frame
Week 8
Title
Intellectual Competence Measured by IQ Score: Month 24
Description
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.
Time Frame
Month 24
Title
Intellectual Competence Measured by IQ Score: Month 60
Description
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.
Time Frame
Month 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Madden, RN, CPNP
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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