- Patients with unstable or untreated (non-irradiated) brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events; subjects with a prior history of CNS metastases will be eligible if the metastases have been treated with either RT or surgical resection ONLY and subjects are asymptomatic, with stable disease and no longer requiring steroids for at least 2 weeks; a screening magnetic resonance imaging (MRI)/CT (with contrast) is required