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

NCT ID: NCT01542736

Last Updated: 2022-01-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Medulloblastoma High Risk Supratentorial PNET Metastatic PNET

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reduced radiation with concurrent chemotherapy

Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

Administered concurrently with craniospinal radiation.

Vincristine

Intervention Type DRUG

Administered concurrently with craniospinal radiation.

24 Gy

Intervention Type RADIATION

Craniospinal radiation.

Interventions

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Carboplatin

Administered concurrently with craniospinal radiation.

Intervention Type DRUG

Vincristine

Administered concurrently with craniospinal radiation.

Intervention Type DRUG

24 Gy

Craniospinal radiation.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Madden, RN, CPNP

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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06-1151

Identifier Type: -

Identifier Source: org_study_id

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