Carboplatin in Treating Patients With Recurrent High-Grade Gliomas

Status Completed

Clinical Trial Summary

This study is being done to evaluate the toxicity and safety of carboplatin administered by convection enhanced delivery into the tumor in patients with high grade glial neoplasms. This study is a dose escalating study, (the dose of the study drug is increased at set time points). Carboplatin is in a class of drugs known as platinum-containing compounds; it slows or stops the growth of cancer cells in your body. Convection enhanced delivery involves placing one or more catheters into the brain and delivering chemotherapy through those catheters directly into the brain

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Establish the maximum tolerated dose and define the toxicity profile of carboplatin delivered intracerebrally via convection enhanced delivery (CED) for patients with high grade glial neoplasms.

SECONDARY OBJECTIVES:

I. Examine the efficacy as defined by six-month progression free survival (PFS), median progression free survival, overall survival, and the radiographic response rate.

II. Evaluate the drug distribution.

OUTLINE: This is a phase I, dose-escalation study.

Patients undergo craniotomy and then receive carboplatin intracerebrally via convection-enhanced delivery (CED) over 72 hours. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01644955
Study type	Interventional
Source	Ohio State University Comprehensive Cancer Center
Contact
Status	Completed
Phase	Phase 1
Start date	June 11, 2012
Completion date	December 8, 2017

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