Everolimus in Treating Patients With Recurrent Low-Grade Glioma (NCT00823459) | Clinical Trial Compass
CompletedPhase 2
Everolimus in Treating Patients With Recurrent Low-Grade Glioma
United States58 participantsStarted 2009-01-23
Plain-language summary
This phase II trial studies how well everolimus works in treating patients with recurrent low-grade glioma. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
Who can participate
Age range18 Years
SexALL
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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 =\< 1.5 x upper limit of normal (ULN)
* International normalized ratio (INR) \< 1.5 (anticoagulation is allowed if target INR =\< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight \[LMW\] heparin for \> 2 weeks at the time of registration)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN
* Serum creatinine =\< 1.5 x ULN
* Fasting serum cholesterol =\< 300 mg/dL OR =\< 7.75 mmol/L AND fasting triglycerides =\< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
* Patients must have histologically proven intracranial low-grade glioma at initial diagnosis; low-grade gliomas i…