Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025311
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2001-10-11
Brief Title:
Topotecan in Treating Patients With Recurrent Progressive or Refractory Cancer That is Metastatic to the Lining Around the Brain
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase I Study Of Seven Day Continuous IntrathecalIntraventricular Infusion Of Topotecan For Patients With Recurrent Progressive Or Refractory Leptomingeal Disease
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2018 | None | None | None |
| NYU-0005H | None | None | None |
| NYU-0041H | None | None | None |