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

You may be eligible if

• 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