 - Subjects with toxicity related to prior anti-cancer therapy andor surgery must either have resolved, returned to baseline or deemed irreversible. Four 4 weeks must have elapsed between surgery andor last dose of prior anti-cancer therapy and the initiation of study therapy. At least 6 weeks must have elapsed between prior therapy with nitrosoureas, mitomycin C, and liposomal doxorubicin. For biologics e.g., monoclonal antibodies such as cetuximab and extended-release formulations, the washout period must extend 1 month beyond the recommended dosing interval e.g., for cetuximab, once per week 1 month wash out 