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

High Risk Supratentorial PNET Clinical Trial

Official title:

Feasibility of Using Concurrent Carboplatin and Reduced Dose Craniospinal Radiation (24Gy) for Metastatic Medulloblastoma, High-Risk Supratentorial PNET and Metastatic PNET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542736
• Other study ID #: 06-1151
• Status: Completed
• Phase: Phase 2
• Start date: May 2007
• Est. completion date: September 2020

Study information

• Verified date: December 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• High Risk Supratentorial PNET
• Medulloblastoma
• Metastatic Medulloblastoma
• Metastatic PNET
• Neuroectodermal Tumors, Primitive

Intervention

Drug:
• Carboplatin
Administered concurrently with craniospinal radiation.
• Vincristine
Administered concurrently with craniospinal radiation.

Radiation:
• 24 Gy
Craniospinal radiation.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free Survival	MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.	Up to 60 months.
Primary	Overall Survival	Overall Survival will be measured at the end of study. number of surviving participants is reported.	up to 5 years
Primary	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.	Week 8
Primary	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.	Month 24
Primary	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.	Month 60