Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.
|Brain and Central Nervous System Tumors||Drug: topotecan hydrochloride||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study Of Seven Day Continuous Intrathecal/Intraventricular Infusion Of Topotecan For Patients With Recurrent, Progressive Or Refractory Leptomingeal Disease|
|Study Start Date:||May 2001|
|Primary Completion Date:||October 2003 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025311
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|Paris, France, 75651|
|Study Chair:||Jonathan L. Finlay, MB, ChB||New York University School of Medicine|