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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR003186-15
Application #
6413067
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1994-12-01
Project End
2004-11-30
Budget Start
Budget End
Support Year
15
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of Wisconsin Madison
Department
Type
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715
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