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