Brain Tumor Clinical Trial
Official title:
Phase II Trial of RAD001 in Patients With Recurrent 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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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