The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
This is a phase I/II study of high dose irinotecan in patients with recurrent unresectable malignant glioma on steroids/anti-epileptics. The purpose is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes Q 3 weeks x 15 patients; Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients; Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.
Kentuckiana Cancer Institute
Louisville, Kentucky, United States
The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
Time frame: 2008
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