Everolimus in Treating Patients With Recurrent Low-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT00823459|
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : April 25, 2019
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adult Diffuse Astrocytoma Adult Mixed Glioma Adult Oligodendroglioma Adult Subependymal Giant Cell Astrocytoma Recurrent Adult Brain Neoplasm||Drug: Everolimus Other: Archival Tissue Analysis||Phase 2|
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).
- To further delineate the safety profile of RAD001 in patients with recurrent LGG.
- To assess overall survival (OS) in patients treated with RAD001.
- To assess the objective response rate (ORR) in patients treated with RAD001.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma|
|Actual Study Start Date :||January 23, 2009|
|Actual Primary Completion Date :||June 12, 2017|
|Actual Study Completion Date :||November 13, 2017|
Experimental: Single-Arm Everolimus
Single-arm study with patients receiving Everolimus orally once daily dosing of 10 mg continuously from Day 1 of study until progression of disease or unacceptable toxicity. In addition archival tissue will be analysed for markers of P13K/mTOR pathway activation.
Other: Archival Tissue Analysis
- Progression-free Survival at 6 Months. [ Time Frame: At 6 months after treatment start ]Number of patients alive without progressive disease at 6 months. Assessment of progression was defined by RANO as a 25% increase in the sum of all the products of measurable lesions, clear worsening of any evaluable disease or any new lesion
- RAD001 Safety Profile in Patients With Recurrent LLG [ Time Frame: 13 months ]Grade 4-5 treatment related adverse events as defined by CTCAE 3.0
- Objective Response Rate (ORR) in Patients Treated With RAD001. [ Time Frame: 12 months ]Objective response is defined as complete or partial response as defined by RANO criteria as determined by MRI and steroid requirement. Complete response was defined by disappearance of all measurable disease with minimal or no steroids; a partial response was defined as 50% in sum of all products in perpendicular diameters of all measurable lesions with no new lesions on stable or decreasing steroids.
- Overall Survival (OS) in Patients Treated With RAD001. [ Time Frame: Time from registration till death, an average of 5 years ]Number of years from the day the patient started treatment until the date of death, an average of 5 years.
- To Assess the Correlation of Activation of the PI3K/mTOR Pathway With Survival [ Time Frame: 5 years ]Survival of patients with p-S6 staining of >19% (activated pathway)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823459
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Susan Chang, MD||University of California, San Francisco|