Clinical Trial: Carboplatin in Treating Patients With Recurrent High-Grade Gliomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: James Elder

Current Primary Outcome: Establish maximum tolerated dose and define toxicity profile [ Time Frame: 72 hours after maximal medical therapy is initiated ]

The toxicity profile of carboplatin delivered intracerebrally via convection enhanced delivery (CED) for patients with high grade glial neoplasms. The maximum tolerated dose (MTD) of infused carboplatin may then be incorporated into future clinical studies.


Original Primary Outcome: Dose-limiting toxicity (DLT) defined as grade 3 or 4 toxicity as defined by the National Cancer Institute Clinical Trials Group version 4.0 that is attributable to the study drug and MTD of convection enhanced delivery of carboplatin [ Time Frame: 72 hours after maximal medical therapy is initiated ]

Descriptive statistics of response/efficacy and tolerance of treatments will be used.


Current Secondary Outcome:

  • Six month progression free survival defined as the proportion of patients with stable disease at 6 months from surgery [ Time Frame: Time between surgery and earliest sign of disease progression or death, assessed up to 6 months ]
  • Median progression free survival [ Time Frame: Time between surgery and earliest sign of disease progression or death, assessed up to 2 years ]
  • Radiographic response rate [ Time Frame: Up to 2 years ]
  • Overall survival [ Time Frame: Time from surgery until death, assessed up to 2 years ]


Original Secondary Outcome: Same as current

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: July 17, 2012
Date Started: June 2012
Date Completion:
Last Updated: July 19, 2016
Last Verified: July 2016