Clinical trial NCT00568048 (phase 2, status: completed)
Conditions: melanoma (skin)
ICD codes: C43.51, C43.9, C43.52, D03.51, C43.8, Z85.820, D03.52
Drugs: temozolomide
SMILES: CSCC[C@H](N)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed melanoma

               -  Unresectable stage IV disease

               -  Mucosal and unknown primary disease allowed

          -  Measurable disease, defined as at least one lesion that can be measured in at least
             one dimension as ≥ 20 mm (or as ≥ 10 mm if the CT slice thickness is ≤ 5 mm)

               -  Measurable lesion must be outside a previously treated area

          -  Must have 1 paraffin block of primary tumor and/or metastatic tissue available for
             analysis of MGMT

          -  No ocular melanoma

          -  No bleeding skin metastases

          -  No CNS metastases (even if previously treated) by brain MRI

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

          -  ANC ≥ 1.5 x 10^9/L

          -  Platelet count ≥ 100 x 10^9/L

          -  Hemoglobin ≥ 90 g/L (transfusion allowed)

          -  Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  ALT and alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in patients with liver
             metastases)

          -  Serum creatinine < 177 μmol/L

          -  Proteinuria < 2+ by urine dipstick OR urine protein ≤ 1 g by 24-hour urine collection

          -  INR ≤ 1.5

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 12 months after
             completion of study treatment

          -  No other primary tumors within the past 5 years, except adequately controlled limited
             basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

          -  No history or evidence of CNS disease unrelated to cancer (e.g., uncontrolled
             seizures) by physical/neurological examination, unless adequately treated with
             standard medical therapy

          -  No frequent vomiting or any other pre-existing medical condition that would preclude
             swallowing and/or absorption of oral medication

          -  No history or evidence of inherited bleeding diathesis or coagulopathy with risk of
             bleeding

          -  No uncontrolled hypertension (i.e., systolic blood pressure > 150 mm Hg and/or
             diastolic blood pressure > 100 mm Hg, measured repeatedly, despite adequate treatment
             with at least two different antihypertensive drugs)

          -  No clinically significant (i.e., active) cardiovascular disease, including any of the
             following:

               -  Cerebrovascular accident/stroke or myocardial infarction within the past 6 months

               -  Unstable angina

               -  New York Heart Association (NYHA) class II or greater congestive heart failure

               -  Serious cardiac arrhythmia (i.e., ventricular arrhythmia, high-grade
                  atrioventricular-block) that requires medication during the study, interferes
                  with regularity of the study treatment, or is uncontrolled by medication

          -  No serious non-healing wound, active peptic ulcer, or non-healing bone fracture

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 6 months

          -  No significant traumatic injury within the past 30 days

          -  No uncontrolled active infection

          -  No known HIV infection

          -  No known hypersensitivity to any of the study drugs or excipients

          -  No evidence of any other disease, metabolic or psychological dysfunction, psychiatric
             disorder, physical examination finding, or clinical laboratory finding giving
             reasonable suspicion of a disease or condition that contraindicates the use of an
             investigational drug, or that may affect patient compliance with study routines, or
             places the patient at high risk from treatment-related complications

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior adjuvant cytokine therapy (e.g., interleukin, interferon)
             or vaccine therapy and recovered

               -  Prior vaccine therapy for stage IV disease allowed

          -  Prior perfusion therapy (limb and liver) for loco-regional disease allowed

          -  No prior chemotherapy for metastatic disease

          -  No prior bevacizumab or other angiogenic inhibitors

          -  No prior radiotherapy to lesion(s) selected for measurement

          -  More than 30 days since prior treatment in a clinical trial

          -  More than 30 days since prior major surgery with high risk of bleeding

          -  More than 24 hours since prior minor surgery

          -  More than 10 days since prior and no concurrent full-dose oral or parenteral
             anticoagulants or thrombolytic agents for therapeutic purposes

               -  Prophylactic use of anticoagulants is allowed (e.g., maintenance of venous
                  catheter)

          -  More than 10 days since prior and no concurrent acetylsalicylic acid (> 325 mg/day) or
             clopidogrel (> 75 mg/day)

          -  No other concurrent non-steroidal anti-inflammatory drugs (NSAIDs)

          -  No concurrent dipyridamole

          -  No concurrent major surgery

          -  No concurrent radiotherapy to the target lesions

          -  No other concurrent experimental drugs or anticancer therapy