7. Adequate normal organ and marrow function as defined below: Haemoglobin >/= 9.0 g/dL Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (> 1500 per mm^3) Platelet count >/= 100 x 10^9/L (>100,000 per mm^3) Serum bilirubin </=1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician AST /ALT </= 2.5 x institutional upper limit of normal Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula Males: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) /72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 / 72 x serum creatinine (mg/dL)