Everolimus in Treating Patients With Recurrent or Progressive Low-Grade Glioma
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- STATUS
- Recruiting
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- participants needed
- 60
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- sponsor
- University of California, San Francisco
Summary
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.
Description
OBJECTIVES: Primary - 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. Secondary - 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. Tertiary - 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.
Details
| Condition | Brain Tumor |
|---|---|
| Treatment | laboratory biomarker analysis, immunohistochemistry staining method, Everolimus |
| Clinical Study Identifier | NCT00831324 |
| Sponsor | University of California, San Francisco |
| Last Modified on | 7 November 2020 |
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