NCT00823459

Everolimus in Treating Patients With Recurrent Low-Grade Glioma

Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Susan Chang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Diffuse Astrocytoma
• Adult Mixed Glioma
• Adult Oligodendroglioma
• Adult Subependymal Giant Cell Astrocytoma
• Recurrent Adult Brain Neoplasm

Interventions

Type	Name	Description
DRUG	Everolimus	Given PO
OTHER	Archival Tissue Analysis	Correlative studies

Timeline

• Start date: 2009-01-23
• Primary completion: 2017-06-12
• Completion: 2017-11-13
• First posted: 2009-01-15
• Last updated: 2020-07-28
• Results posted: 2019-04-25

Locations

1 site across 1 country: United States