A Phase I Study Of Seven Day Continuous Intrathecal/Intraventricular Infusion Of Topotecan For Patients With Recurrent, Progressive Or Refractory Leptomingeal Disease
OBJECTIVES:
- Determine the maximum tolerated dose of intrathecal or intraventricular topotecan in
patients with recurrent, progressive, or refractory leptomeningeal disease.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease
(leukemia or lymphoma vs solid tumor or other malignancy).
Patients receive topotecan intrathecally or intraventricularly continuously on days 1-7.
Treatment repeats every 21 days for up to 7 courses in the absence of disease progression or
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose- limiting toxicity.
Patients are followed for 6 months.
PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study.
Interventional
Primary Purpose: Treatment
Jonathan L. Finlay, MB, ChB
Study Chair
New York University School of Medicine
United States: Federal Government
CDR0000068949
NCT00025311
May 2001
Name | Location |
---|---|
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |