Everolimus and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastasis From Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

* Radiographically confirmed brain metastases with histopathologically confirmed primary non-small cell lung cancer that will benefit from whole-brain radiotherapy
* Must have ≥ 1 measurable intracranial site of disease, according to RECIST criteria, that has not been previously treated with stereotactic radiation
* Must have stable extracranial disease for 4 weeks

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* ANC \> 1,500/mm³
* Platelets \> 100,000/mm³
* Hemoglobin \> 11 g
* BUN ≤ 25 mg
* Serum creatinine \< 1.5 times upper limit of normal (ULN)
* Serum bilirubin ≤ 1.5 times ULN
* Serum transaminases ≤ 2 times ULN (\< 5 times ULN if patient has liver metastases)
* Cholesterol ≤ 300 mg/dL
* Triglycerides ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
* No other malignancies within the past 3 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinomas of the skin
* No severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study, including any of the following:

  * Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within the past 6 months, or serious uncontrolled cardiac arrhythmia
  * Severely impaired lung function (i.e., FEV1 \< 0.8 cc)
  * Uncontrolled diabetes as defined by fasting serum glucose ≥ 1.5 times ULN
  * Any active (acute or chronic) or uncontrolled infection/disorders
  * Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
  * Liver disease, such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
* No known history of HIV seropositivity
* No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
* No active, bleeding diathesis
* No known hypersensitivity to everolimus or other rapamycin (i.e., sirolimus, temsirolimus) or to its excipients
* No history of noncompliance to medical regimens

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from the acute toxicities of any prior therapy
* Prior surgical resection of a brain metastasis allowed

  * The extent of surgical resection in patients having prior resection of 1 of multiple metastases shall be documented as a biopsy, subtotal resection, or total resection as described by the operative report and/or post-operative imaging
* At least 3 weeks since prior major surgery or completion of extracranial radiation
* At least 3 weeks since prior and no concurrent systemic anticancer therapy, other than the study medications administered as part of this study protocol
* At least 6 weeks since prior nitrosoureas
* More than 1 week since prior and no concurrent immunization with attenuated live vaccines
* More than 3 weeks since prior chemotherapy
* No prior brain radiotherapy of any form
* No concurrent chronic treatment with systemic steroids or other immunosuppressive agents, except steroids for neurological stability following the diagnosis of brain metastases
* No prior treatment with an mTOR inhibitor
* No concurrent anti-vitamin K medication, except low dose coumarin
* No concurrent drugs or substances known to be inhibitors or inducers of the isoenzyme CYP3A
* No other concurrent investigational therapy