Clinical trial NCT00072163 (phase 2, status: completed)
Conditions: recurrent melanoma, stage iv melanoma, tumors metastatic to brain
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: temozolomide, thalidomide
SMILES: CSCC[C@H](N)C(O)=O, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic melanoma

          -  Clinical evidence of brain metastases

               -  At least 1 unidimensionally measurable brain lesion at least 2.0 cm by
                  conventional techniques OR at least 1.0 cm by spiral CT scan or MRI

                    -  The following lesions are not considered measurable:

                         -  Bone lesions

                         -  Leptomeningeal disease

                         -  Ascites

                         -  Pleural/pericardial effusion

                         -  Lymphangitis cutis/pulmonis

                         -  Abdominal masses that are not confirmed and followed by imaging
                            techniques

                         -  Cystic lesions

                         -  Lesions situated in a previously irradiated area, unless new growth is
                            documented

          -  Performance status - CTC 0-1

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  AST and ALT no greater than 2.5 times upper limit of normal (ULN)

          -  Lactic dehydrogenase no greater than 2.5 times ULN

          -  Alkaline phosphatase no greater than 2.5 times ULN

          -  Creatinine no greater than 2 mg/dL

          -  No history of active angina

          -  No history of significant ventricular arrhythmia

          -  No history of deep vein thrombosis

          -  No myocardial infarction within the past 6 months

          -  No acute abnormality by EKG

          -  No uncontrolled arrhythmia

          -  No history of pulmonary embolism

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use 1 highly-effective and 1 additional method of contraception
             for 28 days before, during, and for 4 weeks after study participation

          -  No known HIV disease

          -  Thyroid-stimulating hormone normal

          -  Serum anticonvulsant levels normal (for patients on anticonvulsants)

          -  No frequent vomiting and/or any other medical condition (e.g., partial bowel
             obstruction) that would preclude oral medication intake

          -  No preexisting neuropathy greater than grade 1

          -  No uncontrolled seizures

          -  No other concurrent medical condition that would preclude study participation

          -  At least 4 weeks since prior cytokines

               -  Biologic agents used as adjuvants, vaccines, and cellular therapies do not
                  require a 4-week washout period

          -  No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

          -  No more than 1 prior chemotherapy regimen

          -  No prior chemotherapy for brain metastases

          -  No prior continuous daily temozolomide

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

          -  No other concurrent chemotherapy

          -  No concurrent hormonal therapy except steroids and hormones administered for
             non-disease-related conditions (e.g., insulin for diabetes) or for control of
             intracranial edema from brain metastases

          -  See Disease Characteristics

          -  Prior whole brain radiotherapy (WBRT) allowed provided patient has progressive disease
             in a measurable CNS lesion

          -  Prior stereotactic radiotherapy allowed provided patient has progressive disease in a
             measurable CNS lesion

          -  At least 4 weeks since prior WBRT

          -  At least 3 weeks since prior stereotactic radiosurgery

          -  No concurrent radiotherapy

          -  At least 3 weeks since prior surgical resection

          -  No concurrent warfarin or heparin products or their derivatives

          -  No concurrent antiplatelet therapy (e.g., daily aspirin, ibuprofen, or clopidogrel
             bisulfate)

          -  No concurrent bisphosphonates (e.g., zoledronate)