9. Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values: - Serum creatinine </= 2 times the upper normal limit OR a calculated creatinine clearance </= 50 cc/min. - Total bilirubin </= 2 times the upper normal limit. - Alanine aminotransferase (ALT), OR aspartate aminotransferase (AST) </= 3 times the upper limit of normal.