Recurrent Adult Brain Tumor Clinical Trial
Official title:
Intracerebral Convection Enhanced Delivery of Carboplatin for Treatment of Recurrent High-grade Gliomas
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
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.
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