Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200161
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2005-09-12
Brief Title:
Temozolomide RT Followed by Dose Dense vs Temozolomide Retinoic Acid in Pts wGlioblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Randomized Phase II Trial of Concurrent Temozolomide and Radiotherapy Followed by Dose Dense Versus Metronomic Temozolomide and Maintenance Cis-Retinoic Acid for Patients With Newly Diagnosed Glioblastoma and Other Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone Patients will receive standard low dose temozolomide during radiation After radiation they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide
Detailed Description:
This is a randomized phase II study that will test two different adjuvant temozolomide regimens in patients with newly diagnosed glioblastoma multiforme The goal of this study is to identify a regimen that would be appropriate to bring to a phase III trial and compare to the standard dosing regimen of temozolomide recently reported by Stupp et al in the New England Journal of Medicine Secondary goals of this study include prospective analysis of the prognostic impact of MGMT status and generation of preliminary data regarding this treatment strategy for other types of malignant glioma
The decision regarding which treatment patients receive is made randomly Neither them or their doctor can select which treatment the patient will receive There is reason to believe that both of these doses may benefit treating your brain tumor After 6 months of chemotherapy and assuming the brain tumor has not shown any sign of growth they will begin receiving cis-retinoic acid Cis retinoic acid has been shown in one study to possibly prevent or delay tumor recurrence
The decision regarding which treatment patients receive is made randomly Neither them or their doctor can select which treatment the patient will receive There is reason to believe that both of these doses may benefit treating your brain tumor After 6 months of chemotherapy and assuming the brain tumor has not shown any sign of growth they will begin receiving cis-retinoic acid Cis retinoic acid has been shown in one study to possibly prevent or delay tumor recurrence
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