Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026494
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2001-11-09
Brief Title:
Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase III Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases
Status:
COMPLETED
Status Verified Date:
2015-12
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 tumor cells from dividing so they stop growing or die
PURPOSE Phase III trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrent brain metastases
PURPOSE Phase III trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrent brain metastases
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of vinorelbine when administered in combination with temozolomide in patients with recurrent brain metastases phase I accrual completed
Determine the safety and feasibility of this treatment regimen in these patients
Determine the efficacy of this treatment regimen in terms of objective radiographic response and overall and progression-free survival in these patients
OUTLINE This is a dose-escalation study of vinorelbine
Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and oral temozolomide once daily on days 1-7 and 15-21 Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 20-35 patients will be treated at that dose level
Patients are followed every 3-4 months
PROJECTED ACCRUAL A minimum of 3 patients will be accrued for the phase I portion of this study and 20-35 patients will be accrued for the phase II portion of this study within 2 years
Determine the maximum tolerated dose of vinorelbine when administered in combination with temozolomide in patients with recurrent brain metastases phase I accrual completed
Determine the safety and feasibility of this treatment regimen in these patients
Determine the efficacy of this treatment regimen in terms of objective radiographic response and overall and progression-free survival in these patients
OUTLINE This is a dose-escalation study of vinorelbine
Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and oral temozolomide once daily on days 1-7 and 15-21 Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 20-35 patients will be treated at that dose level
Patients are followed every 3-4 months
PROJECTED ACCRUAL A minimum of 3 patients will be accrued for the phase I portion of this study and 20-35 patients will be accrued for the phase II portion of this study within 2 years
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-G01-2025 | None | None | None |
| MSKCC-01088A | None | None | None |