The Phase I objective of this study are: (1) To determine the maximum tolerated dose and the dose-limiting toxicities of CPT-11 when administered every three weeks to patients with progressive or recurrent malignant glioma who are receiving ELAED therapy and those not on such agents. (2) To define the safety profile of every-three-week dosing of CPT-11 in this patient population. (3) To characterize the pharmacokinetics of every-three-week dosing of CPT-11 and its metabolites, SN-38, SN-38 glucuronide (SN-38G), and APC in glioma patients. (4) To assess for evidence of antitumor activity. The Phase II objectives of this study are: (1) To determine the efficacy of CPT-11 in the treatment of glioma patients as measured by six-month progression-free survival and objective tumor response. (2) To further evaluate the safety profile of CPT-11 in patients with glioma.
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