Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Dose Finding and Safety/Efficacy Trial of CPT-11 (Irinotecan) in Patients With Recurrent Malignant Gliomas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients with
recurrent malignant glioma.
OBJECTIVES: I. Determine the maximum tolerated dose of intravenous irinotecan when
administered weekly for 4 weeks in patients with recurrent malignant gliomas. II. Describe
the pharmacokinetics of this route of administration, measuring both irinotecan and the
active metabolite SN-38, and determine the effects of hepatic enzyme inducing drugs, such as
anticonvulsants, on the pharmacokinetics in these patients. III. Determine preliminary
response data and activity of irinotecan in this patient population. IV. Correlate response
with topoisomerase I levels in brain tumor tissue from patients undergoing treatment.
OUTLINE: Patients are stratified based on their use/kind of anticonvulsant drugs. This
stratification yields two arms for this study. Arm I consists of patients who use
anticonvulsant drugs that induce hepatic metabolic enzymes. Arm II consists of patients who
use anticonvulsant drugs that cause modest to no induction of hepatic metabolic enzymes or
no anticonvulsant drug. Three patients in each arm receive irinotecan by 90-minute IV
infusions every week for 4 weeks, followed by a 2 week rest period. The dose is escalated
for the next cohort of 3 patients in the absence of unacceptable dose limiting toxicity. The
6 week course is repeated until unacceptable toxicity or disease progression. Once the
maximum tolerated dose has been established for each arm, additional patients are treated at
that dose level. Patients are followed every 2 months.
PROJECTED ACCRUAL: A minimum of 3 patients will be accrued into the phase I portion of the
study and a total of 18-35 patients will be accrued into each arm of the phase II portion of
the study.
;
Primary Purpose: Treatment
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