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.

Exclusion Criteria:

* Diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment.
* Previous whole brain irradiation.
* Brain metastases eligible to neurosurgery or stereotactic radiation therapy.
* Previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
* Pregnant or nursing women.
* Acute infection requiring intravenous antibiotics.
* Severe vomiting or medical condition which could interfere with oral medication intake.
* Anticonvulsant chronic therapy.