Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498927
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2007-07-10
Brief Title:
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2016-02
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 such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma
PURPOSE This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma
Detailed Description:
OBJECTIVES
Primary
Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide
Secondary
Determine the overall survival of patients treated with this drug
OUTLINE Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis Samples are analyzed by protein expression reverse-transcriptase PCR ELISA and western blot Samples are no longer being collected and tested as of 11209
Primary
Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide
Secondary
Determine the overall survival of patients treated with this drug
OUTLINE Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis Samples are analyzed by protein expression reverse-transcriptase PCR ELISA and western blot Samples are no longer being collected and tested as of 11209
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 |
|---|---|---|---|
| SPRI-PO5096 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-07064 | None | None | None |