Temozolomide and Everolimus in Treating Patients With Stage IV Melanoma That Cannot be Removed by Surgery

DISEASE CHARACTERISTICS:

* Histologically confirmed melanoma with manifestations of metastatic disease.
* Unresectable stage IV malignant melanoma with measurable disease

  * Measurable disease defined as at least one lesion with the longest diameter measured as ≥ 20 mm by CT scan or MRI scan OR ≥ 10 mm by spiral CT
* No previously untreated or unstable active brain metastases within the past 3 months
* No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* ANC ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Hemoglobin ≥ 9.0 g/dL
* Alkaline phosphatase ≤ 3 times institutional upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* AST ≤ 3 times ULN
* INR ≤ 1.5
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients and their partners must use effective contraception during and for ≥ 8 weeks after completion of study treatment
* Able to return to a NCCTG institution for follow-up
* Able to forego foods high in fat content 2 hours prior to and 2 hours after administration of everolimus therapy
* Able to provide blood samples for research purposes
* No hypersensitivity to temozolomide, dacarbazine, or any analog of sirolimus
* No history of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only
* No immunosuppression from any cause, including known HIV infection or chronic immunosuppressive therapy
* No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
* No serious medical condition that may make it unsafe for a patient to enroll in study, including any of the following:

  * Severely impaired lung function (FEV1 \< 1 liter), unstable angina pectoris (ongoing symptoms), ongoing symptomatic congestive heart failure (i.e., NYHA class I-IV) refractory to appropriate therapy, or myocardial infarction within the past 6 months, or serious uncontrolled cardiac arrhythmia
  * Uncontrolled diabetes in spite of optimal therapy (i.e., a history of fasting serum glucose \> 150 mg/dL)
  * Any active (acute or chronic) or uncontrolled infection/disorders
  * Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the study treatment
  * Liver disease (i.e., uncompensated cirrhosis or active hepatitis with elevated liver enzymes)
* No bleeding diathesis
* No concurrent severe condition that would make it undesirable for the patient to participate in this trial or that would jeopardize compliance with the trial

PRIOR CONCURRENT THERAPY:

* Must have recovered from effects of prior antineoplastic therapy
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
* At least 4 weeks since prior immunotherapy
* At least 4 weeks since prior biologic therapy
* At least 4 weeks since prior radiosurgery
* At least 4 weeks since prior investigational therapy for melanoma
* No prior small bowel resection that may significantly alter the absorption of everolimus
* No prior sirolimus or its analogues
* No prior radiotherapy to \> 30% of bone marrow
* No concurrent drugs that may induce CYP3A4 activity
* No concurrent warfarin
* No concurrent grapefruit or grapefruit juice
* No concurrent use or planned use of vaccines containing live virus