Multicenter Phase 2 Evaluation of Temozolomide for Treatment of Brain Metastases of Either Malignant Melanoma, Breast and Non-Small Cell Lung Cancer.
- Cytological/histological diagnosis of either melanoma, non-small cell lung cancer and
- 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
- 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.
- 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
- Anticonvulsant chronic therapy.