Clinical trial NCT00521001 (phase 2, status: completed)
Conditions: melanoma (skin)
ICD codes: C43.51, C43.9, C43.52, D03.51, C43.8, Z85.820, D03.52
Drugs: everolimus, temozolomide
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, CSCC[C@H](N)C(O)=O
Eligibility criteria:

        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