Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I/II Trial of Irinotecan (CPT-11) in Patients With Recurrent Malignant Glioma
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 who
have progressive or recurrent malignant glioma.
OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicities of
irinotecan in patients with progressive or recurrent malignant glioma. II. Define the safety
profile of every 3 week dosing of irinotecan in these patients. III. Characterize the
pharmacokinetic profile of this regimen in these patients. IV. Assess evidence of antitumor
activity in these patients. V. Determine the efficacy of irinotecan in these patients as
measured by 6 month progression-free survival and objective tumor response. VI. Evaluate
further the safety profile of irinotecan in these patients during phase II study.
OUTLINE: This is a dose escalation study. Patients are stratified according to concurrent
enzyme-inducing antiepileptic drugs (EIAEDs)(yes vs no). Group A (without EIAEDs): Patients
receive irinotecan IV over 90 minutes on day 1, followed by up to 3 weeks of rest. Group B
(with EIAEDs): Patients receive the same treatment but dose escalation is performed in
cohorts of 3 patients. The maximum tolerated dose (MTD) is defined as the dose below that at
which 2 of 6 patients experience dose limiting toxicities. The Phase I MTD is the starting
dose recommended for use in the Phase II portion of the study. Treatment continues every 3
weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months
for 1 year, then every 6 months until disease progression. Patients are then followed every 4
months for survival.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for phase I within 10 months. A total of
48 patients will be accrued for phase II within 6-8 months.
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