A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain

Date de début de l'étude : 1 octobre 2003

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)