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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Carboplatin in a volume of 54 ml will be administered intracerebrally by convection enhanced delivery
Patients will undergo surgery, which includes tumor resection and catheter placement, in the operating room.
Ohio State University Medical Center
Columbus, Ohio, United States
Establish maximum tolerated dose and define toxicity profile
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.
Time frame: 72 hours after maximal medical therapy is initiated
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
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