An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2% Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade Glioma
OBJECTIVES: I. Determine the maximum tolerated dose of taurolidine in patients with
recurrent or progressive high-grade glioma. II. Determine the safety and toxicity of this
drug in these patients. III. Determine the pharmacokinetics of this drug in these patients.
IV. Determine the response in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients receive taurolidine IV over 1-4 hours on
days 1-5, 8-12, and 15-19. Treatment repeats every 6 weeks in the absence of disease
progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of
taurolidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months.
PROJECTED ACCRUAL: A total of 4-24 patients will be accrued for this study.
Primary Purpose: Treatment
Jeffrey J. Raizer, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|