Serum bilirubin =< 1.5 x institutional upper limits of normal (ULN); must be obtained within 28 days prior to registration Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registration Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration Liver function test must be obtained within 14 days prior to registration Creatinine =< 1.5 x ULN (=< 28 days prior to registration) Obtained =< 14 days prior to registration: Direct bilirubin =< 1.5 x upper limit of normal (ULN) Creatinine =< 2 X institutional ULN (documented within 28 days of registration) Creatinine =< 2 x ULN obtained =< 14 days prior to registration Obtained within 21 days prior to study registration: total bilirubin =< 2.0 g/dL Obtained =< 2 weeks prior to registration: Total bilirubin =< 1.5 x ULN Obtained within 28 days prior to registration: Creatinine < 1.5 x upper limit of normal (ULN), OR Obtained within 28 days prior to registration: Bilirubin < 2.0 X ULN Obtained within 14 days prior to registration: Creatinine =< 1.5 x the institutional upper limit of normal (ULN) Creatinine =< 1.5 X institutional ULN, completed within 14 days prior to the date of registration OR Obtained =< 35 days prior to registration: total or direct bilirubin < 2 x institutional upper limit of normal (ULN) OBTAINED =< 7 DAYS PRIOR TO REGISTRATION: Total bilirubin =< ULN OBTAINED =< 7 DAYS PRIOR TO REGISTRATION: Creatinine =< 1.5 x ULN Creatinine =< 2 x ULN =< 28 days prior to registration Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) Bilirubin =< 1.5 × upper limit of normal (ULN) obtained within 14 days prior to initiating study treatment. Obtained ? 14 days prior to registration: Total bilirubin ? 1.5 x upper limit of normal (ULN) Obtained =< 14 days prior to registration: Creatinine =< 1.5 x ULN Obtained =< 14 days prior to registration: Total cholesterol =< 1.5 x ULN Obtained =< 14 days prior to registration: Triglycerides =< 1.5 x ULN Obtained =< 14 days prior to registration: Creatinine =< 1.5 x ULN OR Obtained with 21 days of registration: total bilirubin =< 3 x the upper limit of normal (ULN) Total bilirubin =< 1.5 x ULN obtained =< 14 days prior to registration Total bilirubin =< 1.5 x ULN, within 14 days of study registration (within 30 days for pulmonary and cardiac assessments) Obtained =< 14 days prior to registration: Direct bilirubin =< 1.5 x ULN Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained =< 14 days prior to registration Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x upper limit normal (ULN) Creatinine =< 1.5 x ULN obtained =< 14 days prior to registration Obtained within 14 days prior to registration; total bilirubin ? ULN Obtained within 14 days prior to registration; serum creatinine ? 1.5 x ULN Obtained =< 14 days prior to registration: Total bilirubin =< institutional upper limit of normal (ULN) Obtained =< 14 days prior to registration: Serum creatinine =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained within 30 days of study registration Serum creatinine =< 1.5 x ULN, obtained =< 14 days prior to registration Total bilirubin =< upper normal limit (obtained =< 7 days prior to registration) Creatinine =< 1.5 x ULN (obtained =< 7 days prior to registration) Total bilirubin =< 1.5 × the upper limit of the normal range (ULN) obtained =< 14 days prior to registration Obtained =< 28 days prior to randomization:\r\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) Baseline serum testosterone obtained within 60 days prior to registration Liver function test must be obtained within 14 days prior to registration Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) Obtained =< 21 days prior to registration: Total bilirubin =< institutional upper limit of normal (ULN) Within 28 days of study registration: Creatinine < 2.0 x the institutional ULN Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained =< 7 days prior to registration Bilirubin =< 2 x upper limit of normal (ULN), obtained within 14 days prior to registration for protocol therapy ARM A: obtained =< 14 days prior to registration: \r\n* Creatinine =< 1.5 x ULN ARM A: obtained =< 14 days prior to registration: \r\n* Total bilirubin =< 1.5 x ULN ARM B: obtained =< 14 days prior to registration: \r\n* AST/ALT =< 2.5 x ULN ARM B: obtained =< 14 days prior to registration: \r\n* Creatinine =< 1.5 x ULN ARM B: obtained =< 14 days prior to registration: \r\n* Total bilirubin =< 1.5 x ULN ARM B: obtained =< 14 days prior to registration: \r\n* INR =< 1.5 x ULN ARM B: obtained =< 14 days prior to registration: \r\n* aPTT =< 1.5 x ULN Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained =< 14 days prior to registration Creatinine =< 1.5 x ULN, obtained =< 14 days prior to registration OR Bilirubin =< 2 x institutional upper limit of normal (ULN); these results must be obtained within 28 days prior to registration Bilirubin =< 1.5 x ULN obtained within 28 days prior to registration Serum total bilirubin =< twice the institutional upper limit of normal (ULN) within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration) Potassium =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration Magnesium =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration Sodium =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration Phosphorus =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration Aspartate aminotransferase =< 3 x institutional upper limit of normal (ULN), obtained =< 21 days prior to registration and confirmed prior to the first dose of study drug Alanine aminotransferase =< 3 x institutional upper limit of normal (ULN), obtained =< 21 days prior to registration and confirmed prior to the first dose of study drug Obtained =< 7 days prior to registration:\r\nAlkaline phosphatase =< 3 x ULN Obtained =< 7 days prior to registration:\r\nCreatinine =< 2 x ULN Obtained within 14 weeks prior to registration on study: bilirubin < 1.5 x upper limit of normal (ULN) Serum total bilirubin: =< 1.5 x upper limit of normal (ULN) obtained within 14 days prior to registration Total bilirubin =< 1.5 times upper limit of institutional normal (ULN) for age obtained =< 7 days prior to registration Serum creatinine =< 1.5 x ULN (obtained =< 7 days prior to randomization) Total bilirubin =< 1.5 x ULN (tested within 14 days prior to registration) Obtained =< 7 days prior to registration: Creatinine =<1.5 x ULN Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Obtained =< 7 days prior to registration: Creatinine =< 1.5 x institutional ULN Obtained within 14 days prior to registration: Bilirubin within the institutional limits of normal Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) (obtained =< 14 days prior to registration) Male patients must have free and total testosterone level obtained within 28 days prior to registration Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 7 days prior to registration Creatinine =< 1.5 x Institutional ULN obtained =< 7 days prior to registration Obtained =< 30 days prior to registration: Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN); NOTE: can be waived with permission of study chair (documentation such as an email must be provided) Creatinine =< 1.2 X ULN obtained =< 180 days prior to registration Creatinine =< 2.5 x institutional upper limit of normal (ULN) obtained =< 45 days prior to randomization Total bilirubin =< 2 x institutional ULN obtained =< 45 days prior to randomization Creatinine =< 1.5 x the institutional upper limit of normal (ULN), obtained within 14 days prior to treatment start In patients who will receive bortezomib for imaging purposes only:\r\n* Total bilirubin < 1.5 x upper limit of normal obtained within 2 weeks prior to registration\r\n* Platelet count >= 70,000/mm^3 obtained within 2 weeks prior to registration\r\n* No pre-existing peripheral neuropathy greater than grade 1 Creatinine < ULN, performed within 28 days prior to registration Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< the upper limit of normal (ULN) within 4 weeks prior to randomization Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) within 28 days prior to step 1 registration Total bilirubin =< 1.5 x upper limit of normal (ULN) within 28 days prior to step 3 registration Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin ? 1.5 x upper limit of normal (ULN) for age AND Total bilirubin =< 2.0 x upper limit of normal (ULN), within 14 days of registration Total bilirubin =< 1.5 x upper limit of normal (ULN), documented within 14 days of registration Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin ? 1.5 x upper limit of normal (ULN) for age AND Total bilirubin (T. Bili) =< 1.5 X upper limit of normal (ULN) Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range Total bilirubin =< upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 2.0 × the upper limit of the normal range (ULN) Total bilirubin =< 1.5 mg/dL x the upper limit of normal (ULN), within 14 days before the first dose of cabozantinib Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)for age, and Have a serum total bilirubin ?1.5 × ULN (upper limit of normal). Total bilirubin ? 2 × the upper limit of the normal range (ULN) Total bilirubin < 3.0 x ULN (upper limit of normal) Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN), determined within 14 days of registration Total bilirubin =< upper limit of normal (ULN) Within 28 days of study registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total serum bilirubin <1.5 X upper limit of normal (ULN) Total bilirubin ? 1.5 × upper limit of normal (ULN) Total bilirubin =< 1.5 x institution’s upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Adequate organ function within 14 days of study registration including:\r\n* Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 2.0 x institution’s upper limit of normal (ULN) Total bilirubin ? 1.5 x the upper limit of the normal range (ULN). Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) within four weeks of enrollment Total bilirubin: =< 3 X upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dl Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 2 x upper limit of normal (ULN) Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age; participants with biliary or hepatic primaries with bilirubin values greater than 1.5 x ULN may be enrolled on study if all other eligibility criteria are met Total bilirubin =< 1.5 X upper limit of normal (ULN) Serum total bilirubin: =< 1.5 x upper limit of normal (ULN) Total bilirubin =< upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin level =< 1.5 × the upper limit of normal (ULN). Total bilirubin ? 2 x upper limit of normal (ULN) for age Total bilirubin < 1.5 x upper limit of normal (ULN) Total bilirubin =< 3 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 14 days of PET imaging) Total bilirubin level =< 1.5 x upper limit of normal (ULN) Total bilirubin level =< 1.5 x the upper limit of normal (ULN). Total bilirubin =< 1.5 x upper limit of normal (ULN). Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin ? 1.5 x ULN (upper limit of normal) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age\r\n* Temozolomide should not be administered if total bilirubin is > 2.0 mg/dl or SGPT(ALT) > 2.5 x ULN Total bilirubin =< 1.5 x ULN (upper limit of normal) Total bilirubin =< 1.5 x the upper limit of normal (ULN) To be performed within 14 days prior to day 1 of protocol therapy: total serum bilirubin =< 2 x upper limit of normal (ULN) Within 4 weeks of day 1: Total bilirubin =< upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Within 3 days before the first dose of study drug: total bilirubin < upper limit of normal (ULN) Total bilirubin: =< 3 x upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dl Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin level ? 1.5 × the upper limit of normal (ULN) range Total bilirubin =< 1.5 x the upper limit of normal (ULN), obtained within 7 days prior to first study treatment Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Within 7-10 days of study drug administration: Total bilirubin < 3 X upper limit of normal (ULN) for age Total bilirubin concentration of =< 1.5 x the upper limit of normal (ULN) range Total bilirubin: =< 3 x upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dl Total bilirubin =< 1.5 x upper limit of normal (ULN) (results within 7 days before study drug administration) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and Total bilirubin level ? 1.5 × the upper limit of normal (ULN) range Total serum bilirubin within 1.5 x upper limit of normal (ULN) Within 14 days of the first study treatment: Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range Total Bilirubin =< 1.5 x the upper limit of normal (ULN) Total bilirubin < 3 x the upper limit of normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 upper limit of normal (ULN) Total serum bilirubin within 1.5 x upper limit of normal (ULN) Total Bilirubin =< upper limit of normal [ULN] Total bilirubin =< upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of normal range (ULN) Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin level =< 1.5 x the upper limit of normal range (ULN) Total bilirubin level =< 1.5 x upper limit of normal (ULN) Total bilirubin ?1.5 x the upper limit of normal (ULN) Total bilirubin must be less than or equal to (<=) 1.5 * the upper limit of normal (ULN). Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin less than 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) Total bilirubin > 1.5 x the upper limit of normal (ULN) for age Total bilirubin =< upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin > 1.5 x upper limit of normal (ULN) Serum total bilirubin: ? 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for the laboratory Total bilirubin < 2.0 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and Total bilirubin < 2.0 X upper limit of normal (ULN) Concentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Hepatic: total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit normal (ULN) Total bilirubin =< to 1.5 X upper limit of normal (ULN) Total bilirubin > 1.5 x upper limit of normal (ULN) Total bilirubin: =< 1.5 upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for the laboratory Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total serum bilirubin =< 1.5 X upper limit of normal (ULN) Total bilirubin > 1.5 x upper limit of normal (ULN) Total bilirubin =< 2.0 x upper limit of normal (ULN) Serum total bilirubin =< 2.0 x upper limit normal (ULN) or =< 3.0 x ULN if deemed to be elevated due to leukemia Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 1.5 upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin < 1.5 x the upper limit of normal (ULN) Total bilirubin > 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 upper limit of normal (ULN) Total bilirubin < 1 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin >= 1.5 x the upper limit of the normal range (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin ? 1.5 x the upper limit of the normal range (ULN) Total bilirubin =<1.5 x the upper limit of the normal range (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin must be less than or equal to (<=) 1.5* the upper limit of normal (ULN). Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 3 x upper limit of normal (ULN) Total bilirubin < 1.5 X upper limit of normal (ULN) Total bilirubin: =< 3 x upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dl Total bilirubin within normal range; for patients with liver metastases, serum bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin must be less than or equal to 1.5 x upper limit of normal (ULN), and Total bilirubin =< 1.5 x upper limit of normal (ULN), =< 1.8 x ULN with liver metastases Total bilirubin =< upper limit of normal (ULN) Total bilirubin > 1.5 x the upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) Serum total bilirubin < 2.0 x ULN (upper limit of normal) Serum total bilirubin < or = to 1.5 X the upper limit of normal (ULN) Serum total bilirubin =< 1.5 x ULN (upper limit of normal) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total serum bilirubin =< 1.5 x upper limit of normal (ULN) Within 14 days prior to registration: Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) AND Serum total bilirubin =< 2.0 x ULN (upper limit of normal) Within 14 days of enrollment: Total bilirubin level > 1.5 x upper limit or normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Bilirubin (total) < 1.5 X upper limit of normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN), within 14 days prior to study entry Total (T.) bilirubin =< 3 X upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Serum total bilirubin =< 1.5 X upper limit of normal (ULN) Total bilirubin of =< 1.5 x upper limit of normal (ULN) Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN); NOTE: concomitant elevations in bilirubin above 1.0 x ULN is not permitted Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin ?1.5x upper limit of normal (ULN) Total bilirubin ?1.5 × upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of normal (ULN) Total serum bilirubin =< 1.5 X upper limit of normal (ULN) Total bilirubin =< 1.5 X upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Liver function tests performed within 3 weeks prior to starting study therapy must have total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) To be performed within 28 days prior to day 1 of protocol therapy: Total serum bilirubin < upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin < 1.5 x upper limit of normal (ULN) Total bilirubin < 2.5 upper limit of normal (ULN) Total bilirubin =< 5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) Bilirubin (total) < 1.5 X upper limit of normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper normal limit (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Serum total bilirubin < 1.5 x upper limit or normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for the institution Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) within 14 days of enrollment Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 × upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin (TB) =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 X upper limit of normal (ULN) Total bilirubin below the upper limit of normal (ULN) Total bilirubin =< 2.0 x upper limit of normal (ULN) AMKL PATIENTS: Total bilirubin =< 1.5 x upper limit of normal (ULN) total bilirubin must be less than or equal to 1.5 x upper limit of normal (ULN); and Total bilirubin within upper limit of normal (ULN), Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin superior to 2 x ULN (Upper Limit of Normal). Total bilirubin < 3 X upper limited of normal (ULN) for age Total bilirubin >1.5 x upper limit of normal (ULN). Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 X upper limit of normal (ULN) Total bilirubin less than 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin less than 2-fold upper limit of normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin =< 2 x upper limit of normal (ULN) obtained within 4 weeks prior to registration Total bilirubin =< 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin ? 1.5 x upper limit of normal (ULN) with the following exception: Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.25 x upper limit normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 X upper limit of normal (ULN) Serum total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to randomization) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin within ULN (upper limit of normal) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 3 x upper limit of normal (ULN) Total bilirubin =< 1.5 upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin ? 1.5 * the upper limit of the normal range (ULN). Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age Patient has total bilirubin > 2 x ULN (upper limit of normal) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin ? 1.5 X upper limit of normal (ULN) Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range Total bilirubin < 1.5 x upper limit of normal (ULN) for age Total bilirubin =< the upper limit of normal (ULN) Serum total bilirubin =< 1.5 x upper limit normal (ULN) Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< upper limit of normal (ULN) Serum total bilirubin > 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN); 3 x ULN if due to hepatic involvement Total bilirubin ? 1.5 × upper limit of normal (ULN) (? 2 x ULN for subjects with cholangiocarcinoma) Total bilirubin > 3 x upper limit of normal (ULN). Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total serum bilirubin =< the upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 3.0 x upper limit of normal (ULN) Total bilirubin ? 1.5 x the upper limit of the normal range (ULN). Total bilirubin =< 2 X upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 2 x ULN (upper limit of normal) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) obtained =< 14 days prior to randomization Within 14 days after subjects signed the treatment consent: Total bilirubin < upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< upper limit of normal (ULN) Total bilirubin < 1.5 upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x the upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin > 1.5 × upper limit of normal (ULN) Total bilirubin < the upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin 1.5 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) Total bilirubin ?2 × upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal (ULN) range Total bilirubin =< within upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 X upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin =< 3 X upper limit of normal (ULN) Total bilirubin < 2.0 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) Total bilirubin =< upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Within 14 days prior to first study treatment: Total bilirubin =< 1.5 x the upper limit of normal (ULN) Total bilirubin <=1.5*upper limit of normal (ULN). Total bilirubin < 3 x the upper limit of normal (ULN), +/- 7 days from date of ICF signing Total Bilirubin < 2 X upper limit of normal (ULN) Total bilirubin < 2.0 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) Total bilirubin of =< 2 upper limit of normal (ULN) Total bilirubin ? upper limit of normal (ULN); Total bilirubin > 1.5×ULN (upper limit of normal). Total bilirubin <=upper limit of normal (ULN) Serum total bilirubin =< 1.5 x ULN (upper limit of normal) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of normal (ULN) Total serum bilirubin no more than 1.5 x upper limit of normal (ULN) Total bilirubin =< upper limit of normal (ULN) Total bilirubin =< upper limit of normal (ULN) Total bilirubin =< 2 X upper limit of normal (ULN) Total bilirubin ? 2 x Upper Limit of Normal (ULN) Serum total bilirubin ? 1.5 x upper limit of normal (ULN). > 1.5 x upper limit of normal (ULN) total bilirubin Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of normal (ULN) Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin ?1.5 × upper limit of normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< upper limit of normal (ULN) Total bilirubin =< 2 x upper limit of normal (ULN) for age Total bilirubin less than upper limit of normal (ULN) (within four weeks prior to the study) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Serum total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Serum total bilirubin ? 1.5 x upper limit of normal (ULN) within 14 days prior to registration Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Total bilirubin ? 1.5 x upper-normal limit (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total serum bilirubin (TBL) ?1.5 × upper limit of normal (ULN); Total bilirubin =< 1.0 upper limit of normal (ULN) Patient has > 1.5 x upper limit of normal (ULN) total bilirubin Total bilirubin > upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal range (ULN) Total bilirubin =< 3 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) Serum total bilirubin =< 2 x upper limit of normal value (ULN) Total bilirubin < 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of normal (ULN) Total bilirubin > 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x upper limit of normal for age (ULN) Total Bilirubin =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) Total bilirubin level =< 1 x the upper limit of normal (ULN) range Total bilirubin =< 1.5 X upper limit of normal (ULN) Total bilirubin must be <=1.5*the upper limit of normal (ULN). Total bilirubin =< 1.5 x upper limit of normal (ULN) Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< upper limit of normal (ULN) for age Patients with solid tumors: bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age. Total Bilirubin (sum of conjugated + unconjugated) ? 1.5 x upper limit of institutional normal and Bilirubin (sum of conjugated + conjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Total bilirubin (sum of conjugated + unconjugated) ?1.5 x upper limit of normal (ULN) for age Total bilirubin (sum of conjugated + unconjugated) =< 1.5 x institutional upper limit of normal for age Bilirubin (sum of conjugated + unconjugated) ?1.5 times the upper limit of normal (ULN) for age. Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age within 14 days of registration Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age within 7 days prior to enrollment Bilirubin (sum of conjugated + unconjugated) less than 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) ? 1.5 x upper limit of normal (ULN) for age. Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) < 1.5 x upper limit of normal (ULN) Bilirubin (sum of conjugated + unconjugated) ?1.5 × upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) ? 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Within 7 days prior to study registration: Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Adequate hepatic function: Bilirubin (sum of conjugated + unconjugated) ? 2.5 upper limit of normal (ULN) for age (patients with documented Gilbert's Disease may be enrolled with Sponsor approval). Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Patients on Part A and Part B: bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Patients on Part C with ALL: bilirubin (sum of conjugated + unconjugated) =< 1.5 x ULN for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 times institutional upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age and Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age, and Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugate + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled), within 2 weeks of randomization Within 14 days prior to registration: Total Bilirubin =< 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Total bilirubin =< 1.5 x upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Total bilirubin ? 2 times upper limit of normal (ULN). (Participants with known Gilbert's disease who has serum bilirubin ? 3 × ULN may be enrolled). Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum indirect bilirubin level =< 3 X ULN may be enrolled. Total bilirubin ? 2.0 times the upper limit of normal (ULN) of each institution with the following exception: patients with Gilbert Disease serum bilirubin > 3 x ULN. STUDY TREATMENT: Total bilirubin =< 1.5 × upper limit of normal (ULN) within 14 days prior to the first study treatment with the following exception:\r\n* Patients with known Gilbert's disease who have serum bilirubin level =< 3 × ULN may be enrolled. Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Bilirubin =< 1.5 times the upper limit of normal (ULN) for the institution (for patients with known Gilbert's disease: bilirubin =< 3 x ULN) within 14 days of study registration Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following the exception that patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled Obtained within 14 days prior to the first study treatment (cycle 1, day 1): total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: 1) patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled Within 14 days prior to cycle 1 day 1 of treatment: Bilirubin =< 1.5 x upper limit of normal (ULN) (subjects with known Gilbert’s disease who have serum bilirubin =< 3.0 x ULN may be enrolled) Within 14 days prior to the first study treatment (cycle 1, day 1): Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled\r\n* Direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: \r\n* Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled Total bilirubin ? 1.5 x upper limit of normal (ULN) within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level ? 3 x ULN may be enrolled Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled Total bilirubin ? 1.5 × institutional upper limit of normal (ULN) (however, patients with known Gilbert’s disease who have serum bilirubin level ? 3 × ULN may be enrolled) Serum bilirubin ? 1.5 x ULN, with the exception of patients with known Gilbert disease: serum bilirubin level ? 3 x ULN Within 14 days prior to the first study treatment (cycle 1, day 1): Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled. Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n* Patients with known Gilbert disease who have total bilirubin level =< 3 x ULN may be enrolled Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled Patients with known Gilbert disease who have serum bilirubin level ? 3 x ULN may be enrolled. Within 14 days of enrollment: Bilirubin =< 1.5 the upper limit of normal (ULN) for the institution\r\n* For patients with known Gilbert's disease: bilirubin =< 3 x ULN Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Within 14 days prior to the first study treatment (cycle 1, day 1): Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled Obtained within 14 days prior to the first study treatment (cycle 1, day 1); total bilirubin ? 1.5 x upper limit of normal (ULN) with the following exception: \r\n* Patients with known Gilbert disease who have serum bilirubin level ? 3 x ULN may be enrolled Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to the first study treatment [course 1, day 1]) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled Total bilirubin must be 1.5 ULN with the following exception: Patients with known Gilbert disease who have serum bilirubin level 3 ULN may be enrolled. Serum bilirubin =< 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) Total bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases) Within less than or equal to 14 days prior to registration: Total serum bilirubin =< institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), within 21 days prior to registration Total bilirubin < 2 x the institutional upper limit of normal (ULN) Serum total bilirubin =< 1.5X the institutional upper limit of normal (ULN) Total bilirubin < 2 x the institutional upper limit of normal (ULN) Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) OR serum direct bilirubin =< 2 x institutional ULN Total bilirubin =< 1.5 X the institutional upper limit of normal (ULN) Total bilirubin =< 2 X institutional upper limit of normal (ULN) (documented within 28 days of registration) Total bilirubin =<1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN). Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Direct bilirubin =< 1.5 x institutional upper limit of normal (ULN) EXPANDED ACCESS COHORT: Total bilirubin =< 2 x institutional upper limit of normal (ULN) total bilirubin ? 1.5 institutional upper limit of normal [ULN]) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), completed within 14 days prior to the date of registration Total bilirubin =< 1.2 X institutional upper limit of normal (ULN) OR =< 3.0 X institutional ULN if the patient has Gilbert's syndrome Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to start of protocol therapy. Within 14 days prior to registration: Total bilirubin < 1.5 x institutional upper limit of normal (ULN) Total bilirubin level =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total serum bilirubin of =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin level =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN). Total bilirubin =< 2 x institutional upper limit of normal (ULN) (after the HDT/ASCT) Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless Gilbert's disease in which case total bilirubin =< 3 x institutional ULN) Total bilirubin < 1.5 x institutional upper limit of normal (ULN) for age and weight Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) Total bilirubin < 2x institutional upper limit of normal (ULN) within 7 days prior to starting the study drug; Total Bilirubin =< institutional upper level of normal (ULN) at cycle 1 day 1 of TPF Total bilirubin < 2.0 x institutional upper limit of normal (ULN) Total bilirubin =< 2 x institutional upper limit of normal (ULN) Total bilirubin =< institutional upper limit of normal (ULN) Total bilirubin < 1.5 x institutional upper limit of normal (ULN) Direct bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin level =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); and Total bilirubin must be < 2 x institutional upper limit of normal (ULN) Total Bilirubin =< institutional upper level of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Within 14 days of study registration: Total bilirubin =< 3 x upper limit of institutional normal (ULN) Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) Total bilirubin < 4 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 2.0 x institutional upper limit of normal (ULN) Total bilirubin =< 2.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< institutional upper limit of normal (ULN) Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registration Note: ULN is institutional or laboratory upper limit of normal Total bilirubin below normal institutional upper limit of normal (ULN) Total bilirubin < 2 X institutional upper limit of normal (ULN) Total bilirubin greater than 1.5 x the institutional upper limit of normal (ULN) Total bilirubin: =< 2 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 institutional upper limit of normal (ULN) PHASE II: Total bilirubin =< 1.5 institutional upper limit of normal (ULN) Total bilirubin =< 2 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 institutional upper limit of normal (ULN) Total bilirubin < 2.5 x institutional upper limit of normal (ULN) Total bilirubin < 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin < 1.5 x institutional upper limit of normal (ULN) If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN); if known liver metastases, then: total bilirubin < 2.5 x ULN Bilirubin less than or equal to 1.5 x institutional/laboratory upper limit of normal (ULN) Total bilirubin < 2 x institutional upper limit of normal (ULN) Total bilirubin < 1.5 x of institutional upper limit of normal (ULN) SUB-PROTOCOL AIM A: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin <1.5 X institutional upper limit of normal (ULN) Total bilirubin less than 3 x institutional upper limit of normal (ULN) Bilirubin > 1.5 x institutional upper limit of normal (ULN), within 21 days of initiation of protocol therapy Total bilirubin level =< 2.0 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total serum bilirubin =< institutional upper limit of normal (ULN) obtained =<14 days prior to randomization Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN). Total bilirubin =< 2 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) Total bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases) Total bilirubin =< institutional upper level of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) or =< 3.0 x institutional ULN if the patient has Gilbert's syndrome Total bilirubin =< institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total serum bilirubin < institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); =< 3 x institutional ULN if the patient has Gilbert's syndrome Direct bilirubin =< 1.5 X institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Bilirubin within the institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 2 x institutional upper limit of normal (ULN) LUNG ADENOCARCINOMA COHORT (COHORT 3 ONLY): Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) PANCREATIC CANCER COHORT (COHORT 4 ONLY): Total bilirubin =< 2 x institutional upper limit of normal (ULN) Bilirubin =< institutional upper limit of normal (ULN) Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) Total bilirubin =< institutional upper limit of normal (ULN) Total bilirubin =< 2.5 X institutional upper limit of normal (ULN) Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) Total bilirubin less than 2.5 X institutional upper limit of normal (ULN) Total bilirubin =< 2 x institutional upper limit of normal (ULN) Total bilirubin =< 1.2 institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (=< 1.5 x institutional upper limit of normal [ULN] in patients with well documented Gilbert’s syndrome) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin < 2 x the institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 2 x institutional upper limit of normal (ULN) Total bilirubin =< 3 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 3.0 x institutional upper limit of normal (ULN) Total bilirubin =< 3 x institutional upper limit of normal (ULN) Total bilirubin =< 2 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 2 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 × institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 × institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Bilirubin > 1.5 x institutional upper limit of normal (ULN) Bilirubin > 1.5 x institutional upper limit of normal (ULN) Total bilirubin < 2 X institutional upper limit of normal (ULN) Total bilirubin =< 1.25 x the institutional upper limit of normal (ULN) Total bilirubin < 1.5 X institutional upper limit of normal; for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 2 x institutional upper limit of normal for age Bilirubin =< 2.0 x upper limit of institutional normal value Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin concentration =< 1.5 x the institutional upper limit of normal for age Total bilirubin =< 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range Total bilirubin =< 1.3 mg/dl (institutional upper limit of normal) Total bilirubin ? 1.5 x institutional upper limit of normal Total bilirubin =< 1.25 x institutional upper limit Total bilirubin =< 1.2 x institutional upper limit of normal\r\n* With the exception of candidates with a diagnosis of Gilbert’s disease in which case the total bilirubin may extend up to 1.5 x institutional upper limit of normal Bilirubin =< upper limit of institutional normal Total bilirubin =< 1.5 x institutional upper limit of normal Serum bilirubin =< 2.0 x upper limit of institutional normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 2.5 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Bilirubin >= 2 X institutional upper limit of normal Total bilirubin < 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range. Bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal No more than 14 days prior to registration: Total bilirubin =< 1.5 X institutional upper limit of normal Bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal within normal Total bilirubin =< 2.5 X institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Bilirubin >= 2 X institutional upper limit of normal Total bilirubin < 1.5 x institutional upper limit of normal Total bilirubin =< 2.5 x institutional upper limit of normal Total bilirubin =< 2 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin < 1.25 x institutional upper limit of normal Total bilirubin =< 2 x institutional upper limit of normal DONOR: Total bilirubin =< 2x institutional upper limit of normal Total bilirubin =< 2 x institutional upper limit of normal Total bilirubin =< 2.0 X institutional upper limit of normal Total bilirubin =< 2 x institutional upper limit of normal Total bilirubin =< 2.5 x institutional upper limit of normal Total bilirubin =< 2.5 × institutional upper limit of normal Bilirubin < 1.5 x institutional normal for age Total bilirubin =< 2.5 x institutional upper limit of normal Total bilirubin =< institutional upper limit of normal obtained no more than 28 days prior to the start of neoadjuvant endocrine therapy Bilirubin >= 2 x institutional upper limit of normal\r\n* Total bilirubin within normal institutional limits Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin < 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range Patients must have adequate hepatic function as documented by a bilirubin ? 2 x the institutional upper limit of normal, an alkaline phosphatase ? 2 x the institutional upper limit of normal, and an SGOT and SGPT ? 2 x the institutional upper limit of normal all obtained within 14 days prior to enrollment. Total bilirubin =< 1.5 x institutional upper limit of normal Bilirubin =< 1.5 x institutional normal for age Total bilirubin =< 2 x institutional upper limit of normal Total bilirubin =< 2 x institutional upper limit of normal for age Bilirubin =< 1.5x institutional normal for age Total bilirubin: < 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin within institutional upper limit of normal TUMOR BIOPSY SEQUENCING: Total bilirubin < 1.5 x institutional upper limit of normal TREATMENT: Total bilirubin < 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x upper limit of institutional normal Total bilirubin =< the institutional upper limit of normal Total bilirubin =< 1.5 mg/dL x the institutional upper limit of normal Serum direct bilirubin < 2 x institutional upper limit of normal Secondary Registration: total serum bilirubin =< 1.5 x institutional upper limit of normal Total serum bilirubin =< 1.0 x institutional upper limit of normal Total bilirubin =< 2 x institutional upper limit of normal Total bilirubin < 1.5 x institutional upper limit of normal (bilirubin < 3 x institutional upper limit of normal for Gilbert’s syndrome) Total bilirubin =< institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 2 X institutional upper limit of normal Total bilirubin < 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin < 1.5 x institutional upper limit of normal (bilirubin < 3 × institutional upper limit of normal for Gilbert’s syndrome) Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin < 2 x the institutional upper limit of normal Bilirubin =< 1.5 x institutional normal Total bilirubin > institutional upper limit of normal or Total bilirubin: =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 3 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal, within 14 days of study registration Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 2 X institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin below institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal for age Total serum bilirubin =< institutional upper limit of normal Within 14 days of registration: Total bilirubin < institutional upper limit of normal Total bilirubin < 2 x institutional upper limit Total bilirubin =< 1.5 × institutional upper limit of normal Total bilirubin =< x 1.5 upper limit of institutional normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin < 2 x institutional upper limit of normal Total bilirubin =< 2.0 x institutional upper limit of normal Total bilirubin < 1.5 x upper normal institutional limit Bilirubin =< 1.5 x institutional upper limit normal Total bilirubin =< 2.5 X institutional upper limit of normal Total bilirubin within =< 1.5 x institutional upper limit of normal Total bilirubin < 1.5 x institutional upper limit of normal Total bilirubin < 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin: < 1.5 x upper limit of institutional normal for age Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x the institutional upper-normal limit (IUNL) Total bilirubin < 1.5 x institutional upper limit of normal; for patients with Gilbert’s syndrome or levels of indirect bilirubin above the upper limit of normal, direct bilirubin will be used for eligibility and should be < 1.5 x institutional upper limit of normal Total bilirubin =< institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin: within normal institutional limit Bilirubin =< 2 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal Total bilirubin =< 3 x institutional upper limit of normal Total bilirubin < 1.5 x institutional upper limit of normal Total bilirubin =< 2.0 x institutional upper limit of normal Total bilirubin =< institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin within 1.5 x institutional upper limit of normal Total bilirubin < 1.5 X institutional upper limit of normal Bilirubin =< the institutional upper limit of normal Total bilirubin < 2.5 x institutional upper limit of normal Total bilirubin =< institutional upper limit of normal Total bilirubin within the upper limit of normal based on institutional values Total bilirubin =< 1.5 institutional upper limit of normal Total bilirubin =< 1.5 x upper limit of institutional normal Total bilirubin =< 1.5 x institutional upper limit of normal Within 30 days of eligibility confirmation: Total bilirubin =< 1.5 X institutional upper limit of normal Bilirubin =< upper limit of institutional normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 X institutional upper limit of normal Total bilirubin =< 1.5 x institutional upper limit of normal (within 14 days of study registration) Total bilirubin =< 1.5 X institutional upper limit of normal total bilirubin ? 1.5 X institutional upper normal limit (UNL), Renal insufficiency as indicated by a creatinine level >3 times ULN Adequate renal function, as indicated by creatinine =< 1.5 x ULN Adequate renal function, as indicated by creatinine =< 1.5 x the upper limit of normal (ULN) Patients are required to have adequate renal function as indicated by a serum creatinine =< 2.5 mg/dL; this value must be obtained within four weeks before protocol entry Renal insufficiency as indicated by a creatinine level > 2 x the ULN. Inadequate renal function as indicated by serum creatinine >= 1.5 times the upper limit of normal Adequate renal function, as indicated by creatinine =< 1.5 x upper limit of normal (ULN) Adequate renal and liver function as indicated by: Bilirubin =< 1.5 x ULN Bilirubin =< 2 x ULN Bilirubin =< 1.5 x ULN Bilirubin ?1.5 × institutional ULN. Bilirubin up to 2.5 x ULN. Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 x ULN bilirubin <= 1.5 x ULN* * Unless considered to be due to leukemic organ involvement i. Subjects who are < 75 years of age may have a bilirubin of <= 3.0 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 x ULN. Bilirubin =< 1.5 x ULN bilirubin ? 1.5 x ULN; Bilirubin =< 5 x ULN Bilirubin =< 1.5 x ULN bilirubin ? 1.5 × ULN* ° Subjects who are < 75 years of age may have bilirubin of ? 3.0 × ULN Bilirubin =< 1.5 x ULN Bilirubin > 2 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 x ULN bilirubin ? 1.5 x ULN Bilirubin =< 2 x ULN PHASE I: Bilirubin < 1.5 x ULN Bilirubin =< 1.5 x ULN Conjugated bilirubin <1.5 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 2 x ULN (must be within 7 days of MLA) Bilirubin > 1.5 x ULN Bilirubin =< 1.5 x ULN bilirubin ? 1.5 x ULN Bilirubin =< 1.5 X ULN Bilirubin =< 1.5 x ULN Bilirubin level < 1.5 x ULN Bilirubin < 1.5 x ULN; transaminases < 3 x ULN Bilirubin =< 1.5 X ULN Conjugated bilirubin =< 2 x ULN Bilirubin =< 2.5 x ULN Bilirubin =<1.5 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 ULN Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 2 x ULN Bilirubin less than or equal to 1.5 x ULN Bilirubin =< 1.5 x ULN Conjugated bilirubin <1.5 × ULN Bilirubin < ULN Bilirubin =< 1.5 x ULN Bilirubin less than or equal to 1.5 x ULN Bilirubin =< 1.5 x ULN Bilirubin ?1.5 × institutional ULN; Bilirubin > 2.5 x ULN Bilirubin ?1.5 x ULN Bilirubin less than or equal to 1.5 ULN Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 ULN Bilirubin =< 1.5 x ULN Bilirubin >= 3 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 2 x ULN (must be within 7 days of MLA) Bilirubin =< 1.5 x ULN Bilirubin =< 3 x ULN Bilirubin < 1.5 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 5 x ULN Bilirubin =< 1.5 x ULN Bilirubin =< 1.5 x ULN Bilirubin < 2.5 ULN Bilirubin ? 1.5 x the ULN Bilirubin =< 1.5 x ULN Bilirubin =< 2 x ULN Bilirubin =< 1.5 x ULN Bilirubin < 1.5 × ULN. Bilirubin ? 1.5 x ULN Bilirubin needs to be less than or equal to 1.3 x ULN Bilirubin ? 1.5 x ULN Bilirubin less than or equal to 1.5 x ULN Bilirubin < 5 ULN Bilirubin < 1.5 ULN Bilirubin < 1.5 x ULN Bilirubin < 1.5 x ULN Bilirubin less than or equal to 1.5 x ULN Bilirubin > 1.5 X ULN Bilirubin =< 1.5 x ULN Bilirubin > 1 x ULN for the laboratory Bilirubin < 2 x ULN Bilirubin < 1.5 x ULN Bilirubin > 1.5 x ULN Bilirubin > 1.5 x ULN Bilirubin > 1.5 x ULN Patients must have total bilirubin =< 1.5 x IULN Patients must have total bilirubin =< 2.5 x IULN Direct bilirubin =< 1.5 x IULN (=< 5 x IULN if secondary to lymphoma) within 28 days prior to registration Patients must have total bilirubin =< 2.0 x IULN within 14 days prior to registration Total bilirubin =< 2.0 x IULN within 14 days prior to registration Patients must have bilirubin =< 2 x IULN within 7 days prior to registration (unless the bilirubin is primarily unconjugated) Total bilirubin =< 1.5 x the IULN Serum total bilirubin =< 1.5 x IULN OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN Bilirubin =< 1.5 x IULN Bilirubin 1.5-2 x IULN Total bilirubin =< 1.5 x international upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN ARM B COHORT 3: Total bilirubin =< 1.5 x IULN ARM C COHORT 4: Total bilirubin =< 2 X IULN Total bilirubin < 3 x IULN Total bilirubin =< 1.5 x IULN Total bilirubin =< 1.5 x IULN Total bilirubin =< 1.5 x IULN Total bilirubin =< 1.5 x IULN Total bilirubin < 1.5 x IULN REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Total bilirubin =< IULN Total bilirubin =< 1.5 x IULN Total bilirubin =< 1.5 x IULN within 14 days prior to Step 3 registration Total bilirubin =< IULN; or total bilirubin =< 3.0 x IULN or direct bilirubin =< 1.5 ULN in patients with well documented Gilbert’s syndrome Total bilirubin =< 1.5 x IULN Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN Total bilirubin >= 2 x IULN Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN), within 28 days prior to administration of study treatment Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatment Serum creatinine =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatment Within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) Within 7 days prior to administration of study treatment: Total bilirubin =<1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert’s disease). Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatment Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment) Serum creatinine =< 1.5 X institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 28 days prior to administration of study treatment. Within 28 days prior to administration of study treatment: Total bilirubin ? 1.5 x institutional upper limit of normal (ULN) Measured within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Within 28 days prior to administration of therapy: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Total bilirubin =< 1.5 x institutional upper limit of normal, measured within 28 days prior to administration of study treatment Serum creatinine =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatment Measured within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Measured within 28 days prior to administration of study treatment: Serum creatinine =< 1.5 x institutional upper limit of normal (ULN) Creatine Kinase ? 1.5x the upper limit of normal Dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash or scleroderma Creatine phosphokinase (CPK) ? 2.5 × ULN. Creatine kinase (CPK) =< 1.5 x ULN. Creatine kinase measurement (CPK) 250 mg/dL Creatine kinase (CK)-MB =< ULN Creatine phosphokinase (CPK) ? ULN obtained ? 14 days prior to randomization creatinine phosphokinase isozymes CPK-MB and CPK-MM ? ULN; Patients with serum creatine >= 1.5 mg/dL Serum CK/CPK ?2.5 x ULN. Troponin-I, creatine kinase muscle and brain (CK-MB), B-type natriuretic peptide (BNP) =< ULN Troponin-I, creatine kinase MB (CK-MB), B-type natiuretic peptide (BNP) =< ULN Plasma creatinine phosphokinase (CK) < 1.5 x ULN Plasma creatine phosphokinase (CK) < 1.5 x ULN Plasma creatine phosphokinase (CK) < 1.5 x ULN Creatine > 2.5 mg/dl Creatine kinase (CPK) =< 2.5 x ULN Subjects with creatine kinase > ULN Creatine kinase < 5 X institutional ULN Creatine phosphokinase (CPK) ? 2.5 × ULN. Creatine phosphokinase (CPK) < 2.5 X ULN Plasma creatine phosphokinase (CK) less than 1.5 x ULN Plasma creatine phosphokinase (CK) < 1.5 x ULN Creatine kinase (CK) =< 2.5 times the upper limit of normal Has neuromuscular disorders associated with an elevated creatine kinase Plasma creatine phosphokinase (CK) < 1.5 x upper limit of normal (ULN) Plasma creatinine phosphokinase (CK) < 1.5 x ULN Creatinine phosphokinase (CPK) within 2.5 x upper limit of normal (CTCAE 4.0 grade 1 abnormality is acceptable) Patients with baseline creatinine kinase (CK) > ULN Creatine phosphokinase =< institutional upper limit of normal Creatine: =< 2 mg/dL Plasma creatine phosphokinase (CK) < 1.5 x ULN, if known The subject has creatine phosphokinase (CPK) elevation NCI CTCAE grade greater than equal to (>=) 2, and/or a previous history of myositis or rhabdomyolysis. Serum CK ?1.5 ULN Creatine phosphokinase (CPK) ?2.5 × the ULN. Plasma creatine phosphokinase (CK) < 1.5 x ULN Adequate organ function as evidenced by the following peripheral blood counts or serum chemistry values: hemoglobin 9 gram per deciliters (g/dL), absolute neutrophil count (ANC) 1,500/L, platelet count 100,000/L, serum creatinine 1.5*the upper limit of normal (ULN), creatine phosphokinase (CPK) 2.5 Upper Limit of Normal [ULN] Patients must have no signs of significant rhabdomyolysis determined by creatine phosphokinase (CPK) levels with a creatine kinase (CK) < 5 times the upper limit of normal Creatine phosphokinase (CPK) =< the institutional upper limit of normal Plasma creatine phosphokinase (CK) < 1.5 x ULN History or presence of myopathy or raised creatine kinase (CK) >5 x upper limit of normal (ULN) on 2 occasions at screening. Creatine phosphokinase (CPK) =< 2.5 x ULN Creatine phosphokinase (CPK) =< 2.5 x ULN