Everolimus in Treating Patients With Recurrent Low-Grade Glioma

Inclusion Criteria

• Patients must have a Karnofsky performance status of >= 60
• Patients must have a life expectancy > 8 weeks
• All patients must sign an informed consent document indicating that they are aware of the investigational nature of this study
• Patients must sign an authorization for the release of their protected health information
• Patients must have a magnetic resonance imaging (MRI) scan performed within 14 days prior to initial protocol treatment
• Patients must be registered in the University of California at San Francisco (UCSF) Neuro-Oncology database prior to treatment with study drug
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
• Platelets >= 100 x 10^9/L
• Hemoglobin (Hb) > 9 g/dL
• Serum bilirubin = 2 weeks at the time of registration)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = = 5 days on a stable dose of steroids
• An MRI must be used throughout the period of protocol treatment for tumor measurement
• Patients must have evaluable disease
• Patients may have had treatment (including radiotherapy) for any number of relapses prior to this recurrence
• Patients must be at least 4 weeks from the completion of any radiation therapy
• Patients must be less than 4 months from the surgical procedure for this recurrence
• Patients must have recovered from the toxic effects of prior therapy:
• 4 weeks from any investigational agent
• 4 weeks from prior cytotoxic therapy (except 6 weeks from nitrosoureas, 3 weeks from procarbazine, 3 weeks from vincristine)
• 3 weeks for non-cytotoxic or biologic agents e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, tarceva, etc; note a 3-week washout is required for prior treatment with bevacizumab

Exclusion Criteria

• Patients who have not recovered from the side effects of a major surgery or significant traumatic injury or patients that may require major surgery during the course of the study
• Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent; topical or inhaled corticosteroids, and treatment with low dose Decadron (= 1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy)
• Active (acute or chronic) or uncontrolled severe infections
• Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)
• A Hepatitis B/C blood test must be done at screening for all patients; patients who test positive for Hepatitis C antibodies and the Hepatitis B antigen are ineligible
• A known history of human immunodeficiency virus (HIV) seropositivity
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Impaired lung function: O2 saturation 88% or less at rest on room air by pulse oximetry; if O2 saturation is =< 88% at rest, further pulmonary function tests (PFTs) should be ordered to confirm normal pulmonary function and eligibility
• Patients with an active, bleeding diathesis
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes (women of childbearing potential [WOCBP] must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)
• Male patient whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
• Patients who have received prior treatment with an mammalian target of rapamycin (mTOR) inhibitor (e.g., sirolimus, temsirolimus, everolimus)
• Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients
• History of noncompliance to medica