Everolimus in Treating Patients With Recurrent or Progressive Low-Grade Glioma
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with recurrent or progressive low-grade glioma.
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma|
- Progression-free survival at 6 months [ Time Frame: months ] [ Designated as safety issue: No ]
- Objective response rate [ Time Frame: years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: years ] [ Designated as safety issue: No ]
- Correlation of phosphorylated PKB/Akt and PTEN expression with response, progression status by 6 months, and overall response [ Time Frame: years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
|Drug: everolimus Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- To determine the 6-month progression-free survival (PFS) of patients treated with everolimus who were initially diagnosed with low-grade glioma and underwent biopsy or subtotal resection at the time of recurrence with pathologic evidence of recurrent low-grade glioma.
- To further describe the safety profile of this drug in these patients.
- To assess overall survival (OS) of patients treated with this drug.
- To assess the objective response rate in patients treated with this drug.
- To assess the correlation of phosphorylated PKB/Akt and PTEN expression with response, progression status by 6 months, and OS of patients treated with this drug.
- To determine the 6-month PFS of patients treated with this drug who also underwent prior radiotherapy.
OUTLINE: Patients receive oral everolimus once daily. Courses repeat every 8-12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients may continue treatment for as long as benefit is shown.
Previously collected tissue samples are analyzed by IHC for phosphorylated PKB/Akt status and PTEN expression for correlation with study endpoints.
After completion of study treatment, patients are followed for 30 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831324
|Contact: Thelma Munozfirstname.lastname@example.org|
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222|
|Principal Investigator:||Susan M. Chang, MD||University of California, San Francisco|