Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT00823459
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2009-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Everolimus in Treating Patients With Recurrent Low-Grade Glioma
Sponsor:
Susan Chang
Organization:
Study Overview
Official Title:
Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma
Status:
COMPLETED
Status Verified Date:
2020-07
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:
This phase II trial studies how well everolimus works in treating patients with recurrent low-grade glioma. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
Detailed Description:
PRIMARY OBJECTIVES:
1\. To determine progression-free survival at 6 months associated with use of RAD001 (everolimus) in patients initially diagnosed with low-grade glioma who undergo biopsy or subtotal resection at the time of recurrence with pathologic evidence of recurrent low-grade glioma (LGG).
SECONDARY OBJECTIVES:
1. To further delineate the safety profile of RAD001 in patients with recurrent LGG.
2. To assess overall survival (OS) in patients treated with RAD001.
3. To assess the objective response rate (ORR) in patients treated with RAD001.
4. To assess the correlation of protein kinase B (PKB)/Akt and phosphatase and tensin homolog (PTEN) expression with response, progression status by 6 months, and OS in patients treated with RAD001.
1\. To determine progression-free survival at 6 months associated with use of RAD001 (everolimus) in patients initially diagnosed with low-grade glioma who undergo biopsy or subtotal resection at the time of recurrence with pathologic evidence of recurrent low-grade glioma (LGG).
SECONDARY OBJECTIVES:
1. To further delineate the safety profile of RAD001 in patients with recurrent LGG.
2. To assess overall survival (OS) in patients treated with RAD001.
3. To assess the objective response rate (ORR) in patients treated with RAD001.
4. To assess the correlation of protein kinase B (PKB)/Akt and phosphatase and tensin homolog (PTEN) expression with response, progression status by 6 months, and OS in patients treated with RAD001.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: