NCT01644955

Carboplatin in Treating Patients With Recurrent High-Grade Gliomas

Intracerebral Convection Enhanced Delivery of Carboplatin for Treatment of Recurrent High-grade Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: James Elder · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Oligodendroglioma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
DRUG	carboplatin	Carboplatin in a volume of 54 ml will be administered intracerebrally by convection enhanced delivery
PROCEDURE	Surgery	Patients will undergo surgery, which includes tumor resection and catheter placement, in the operating room.

Timeline

• Start date: 2012-06-11
• Primary completion: 2017-12-08
• Completion: 2017-12-08
• First posted: 2012-07-19
• Last updated: 2018-07-02

Locations

1 site across 1 country: United States