Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)

Inclusion Criteria

• •Cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast;
• •Brain metastases \>=1 cm presenting or in progression following \>=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies;
• •Magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in T1 and T2 before and after gadolinium enhancement.
• •Presence of al least one bidimensionally measurable and not previously irradiated metastasis.
• •Age \<=70 years.
• •Performance status 0-2 (ECOG-WHO scale).
• •Blood leukocytes \>=3.5 x 10\^9/L and platelets \>=100 x 10\^9/L.
• •Bilirubin \<=25 M/L.
• •Seric transaminases \<=2 x upper limit of normal values.
• •Creatinine \<=150 M/L, creatinine clearance \>=60 mL/min.
• •Signed written informed consent.