Must have alanine transaminase (ALT) ? 3 × institutional upper limit of normal (ULN) [? 5 × ULN in presence of liver metastases] within 14 days prior to randomization.

Creatinine level greater than 1.5 times the upper limit of normal

AST/ALT =< 3 x upper limit of normal (ULN)

Patients must have AST and ALT =< 2.5 x institutional upper limit of normal (IULN)

Creatinine =< 1.5 x upper limit of normal (ULN) or

Creatinine =< 1.5 x upper limit of normal (ULN)

Within 14 days prior to registration: Creatinine =< 1.5 x institutional upper limit of normal (ULN)

Creatinine =< 1.5 x institutional upper limit of normal within 4 weeks before randomization

Creatinine =< 1.5 x upper limit of normal (ULN) documented within 28 days prior to step 1 registration

AST =< 8 x upper limit of normal (ULN)

AST and ALT =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration

Creatinine < 1.5 times institutional upper limit of normal, within 21 days prior to study entry

ALT (SGPT) < 10 x upper limit of normal (ULN) for age

Alanine transaminase (ALT) < 3.0x the upper limit of normal (ULN)

Creatine Kinase ? 1.5x the upper limit of normal

Serum creatinine =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatment

Creatinine =< 1.5 x upper limit of normal

ALT (SGPT) < 10 x upper limit of normal (ULN) for age

Serum creatinine ? 2 × upper limit of normal (ULN) OR

Adequate renal function as evidenced by a serum creatinine =< 1.5 x upper limit of normal (ULN)

Patients with a creatinine =< 2 x upper limit of normal for age

Serum creatinine =< 1.5 x institutional upper limit of normal (ULN) OR

INCLUSION CRITERIA FOR SECOND-LINE THERAPY: For patients with known hepatic metastases, AST and ALT =< 5 X the upper normal limit of institution's normal range

INCLUSION CRITERIA FOR THIRD-LINE THERAPY: AST and ALT =< 3 X the upper normal limit of institution's normal range

INCLUSION CRITERIA FOR THIRD-LINE THERAPY: For patients with known hepatic metastases, AST and ALT =< 5 X the upper normal limit of institution's normal range

Creatinine =< 1.5 x upper limit of normal

Serum creatinine < 1.5 times upper limit of normal OR

Alkaline phosphatase < 2.5 x upper limit of normal if no documented liver disease or < 6 x upper limit of normal if documented liver or bone disease

Serum creatinine =< 1.5 X institutional upper limit of normal\r\n* Creatinine (Cr) < 2, blood urea nitrogen (BUN) < 100 mg/dL

Serum creatinine ? 1.5 × upper limit of normal (ULN)

Serum glutamate pyruvate transaminase (SGPT) =< 10 x the institutional upper limit of normal for patients on Stratum A; Stratum B patients must have SGPT =< 4 x the institutional upper limit of normal.

Serum creatinine =< 1.5 x upper limit of normal (ULN) OR

Creatinine > 1.5 × upper limit of normal (ULN).

Creatinine within less than the institutional upper limit of normal

Serum lipase =< 1.5 x institutional upper limit of normal

Serum amylase =< 1.5 x institutional upper limit of normal

Corrected calcium level >= lower limit of the institutional normal range

Creatinine =< 1.5 X the institutional upper limit of normal (ULN)

Serum AST/ALT < 3X the upper limit of normal (ULN) for the reference lab (< 5X the ULN for patients with known hepatic metastases)

Creatinine =< 1.5 x upper limit of normal

Blood urea nitrogen (BUN) =< 1.5 x upper limit of normal range

Creatinine =< 1.5 x upper limit of normal range

PIK3CA WILD TYPE COHORT (closed 03/17/2016): AST(SGOT)/ and ALT(SGPT) =< 2.5 X institutional upper limit normal

ENDOCRINE RESISTANT AND ADJUVANT COHORT: AST(SGOT)/ and ALT(SGPT) =< 2.5 X institutional upper limit normal

Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN), equivalent to the active version of the NCI adverse event (AE) grade 1

TREATMENT: Creatinine =< 2 x upper limit of normal for age

SGPT (ALT) =< 5 x upper limit of normal (ULN) for age

If requires pheresis to collect blood, creatinine (Cre) < 1.5 upper limit of normal

AST less than 5 times the upper limit of normal

Serum creatinine less than 3 times upper limit of normal

Serum creatinine ?1.5 × upper limit of normal (ULN);

Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance <30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per ?L

For WM, serum immunoglobulin M (IgM) with a minimum IgM level of ? 2 times the upper limit of normal (ULN).

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Obtained =< 2 weeks prior to registration: Serum creatinine =< 1.5 x upper limit of normal (ULN)

Obtained within 28 days prior to registration: Creatinine < 1.5 x upper limit of normal (ULN), OR

Serum creatinine =< 2 x the upper limit of normal (ULN)

INCLUSION - PROCUREMENT: If pheresis required to collect blood:\r\n* Creatinine <1.5 × upper limit normal

INCLUSION - TREATMENT: AST less than 5 times the upper limit of normal

Obtained within 14 days prior to registration: Creatinine =< 1.5 x the institutional upper limit of normal (ULN)

Serum phosphorus >= lower limit of normal (LLN)

Serum creatinine =< 1.5 times upper limit of institutional normal for age, or and documented within 14 days prior to registration and within 14 days prior to the start of treatment

AST (SGOT) and ALT (SGPT) ? 2.5 × institutional upper limit of normal (ULN) [? 5 × ULN in presence of liver metastases]

Serum creatinine: =< 1.5 x upper limit of normal (ULN) within 8 weeks of pre-registration

Serum potassium and magnesium greater than the institutional lower limit of normal (LLN).

INCLUSION - INFUSION: Patients with a creatinine ? 2 x upper limit of normal for age

Fasting triglycerides =< 1.5 x upper limit of normal (ULN)

Serum creatinine < 2 x upper normal limit

Serum creatinine < 1.5x institution upper limit of normal

Serum Creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine ? 1.5 X age-adjusted upper limits of normal (ULN)

Serum Creatinine ?1.5 × institutional upper limit of normal (ULN)

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine ? 1.5 x upper limit of normal (ULN) or Creatinine clearance ? 50% of lower limit of normal (LLN)

serum creatinine < upper limit of normal (ULN);

Creatinine > 1.5 × upper limit of normal (ULN)

AST and ALT ? upper limit of normal

Serum creatinine value of < 1.5 times the upper limit of normal (ULN)

Mg ? lower limit of normal

Thyrotropin/25-hydroxyvitamin D levels < lower limit of normal

Creatinine =< 1.5 x institutional upper limit of normal (ULN)

Aspartate transaminase (AST) ? 3X upper limit of normal

Serum creatinine ? 2X upper limit of normal

Creatinine ?1.5 x the upper limit of normal

Hepatic: direct bilirubin ? 3 x upper limit of normal, or AST/ALT ? 5 x upper limit of normal

Serum creatinine ? 2 x upper limit of normal

Serum creatinine ? 1.5 x upper limit or normal

Platelets >= institutional lower limit of normal

ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Patients with a creatinine ? 2 x upper limit of normal for age

Patients with a creatinine ? 2x upper limit of normal for age

Creatinine < 2.0 times upper limit of normal

Serum creatinine < 1.5 times upper limit of normal; OR

Partial thromboplastin time =< 1.66 times upper limit of normal

Creatinine =< 2.0 x upper limit of normal (ULN)

Serum creatinine =< 1.5 X upper limit of normal (ULN)

INCLUSION - TREATMENT: Serum creatinine ? 2x upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Magnesium >= lower limit of normal

AST/SGOT and ALT/SGPT < 2.5 x the institutional upper limit of normal (IULN).

PART II: SGOT and SGPT =< 3 x upper limit of normal (ULN)

Serum creatinine =< 1.5 x upper limit of normal (ULN) for reference lab

Creatinine ? 1.5 x upper limit of normal

AST ? 5 x upper limit of normal

Creatinine < 1.5 x upper limit of normal (or ULN)

Patients with impaired renal function as evidenced by creatinine-clearance < 50% for age, weight, height or serum creatinine > 2 x upper normal limit or dialysis-dependent

Within 14 days of randomization: Creatinine =< 1.5 x the institutional upper limit of normal (ULN)

Subjects must have serum lactate dehydrogenase (LDH) > institutional upper limit of normal (ULN) at time of study enrollment

Creatinine =< 1.5 x the upper limit of normal (ULN)

Baseline serum troponin above the upper limit of normal

Baseline amylase above the upper limit of normal

Patients with 5-­hydroxyindoleacetic acid (HIAA) levels above or below the upper limit of normal range (normal: 0 to 15 mg/24 hours) and those with unknown values at baseline are allowed to participate

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine =< 2 x the institutional upper limit of normal.

Serum creatinine < 1.5 times institutional upper limit of normal

Serum creatinine ? 2 x the upper limit of normal (ULN)

Patients with uncorrectable electrolyte abnormalities with potassium (K) > ULN (upper limit of normal)

Creatinine =< 1.5 X upper limit of normal (ULN)

Creatinine =< 1.5 x institutional upper limit of normal (ULN), within 2 weeks of registration

Creatinine =< 1.5 x institutional upper limit of normal

Corrected calcium value =< 1.1 x upper limit of normal (ULN)

PT-INR > 2x upper limit of normal reference range (ULN) in the absence of anticoagulation within 7 days prior to Day 1

Renal and hepatic disorders with values of >1.5 times the upper limit of normal (ULN) or blood disorders (upon clinician judgment);

Aspartic transaminase (AST) =< 1.5 x upper limit of normal (ULN).

Serum creatinine =< 1.5 x upper limit of normal (ULN) OR

Serum creatinine =< upper limit of institutional normal

Creatinine =< 1.5 x institutional upper limit of normal

Serum creatinine level less than or equal to 1.5 x institutional upper limit normal (ULN) (CTCAE v4.03 grade 1)

AST and ALT ? 5 x the upper limit of normal

Quantitative serum IgG levels for subjects with IgG MM must not exceed the institutional upper limit of normal (ULN)

Cardiac troponin value above the Upper Limit of Normal (ULN);

Serum lactate dehydrogenase (LDH) level =< 1.5 upper limit of normal (ULN) within 28 days prior to enrollment

AST and ALT ? 3.0 X the upper normal limit of institution's normal range

PT and PTT must be ? 1.5 X upper normal limit of institution's normal range

Serum creatinine > 2 times the upper limit of normal

Within 14 days prior to registration: Creatinine =< 1.5 x upper limit of normal (ULN)

Phosphorus =< institutional upper limit of normal

Serum alanine aminotransferase (ALT) =< 3.5 times the upper limit of normal within 21 days prior to initiation of therapy

Alanine transaminase (ALT) =< 2.5 x upper normal limit (ULN) (=< 5 x ULN for subjects with documented metastatic disease to the liver).

REP ELIGIBILITY: Serum ALT and AST less than three times the institutional upper limit of normal

CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Serum ALT and AST less than three times the institutional upper limit of normal

CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: PT and PTT less than or equal to 1.5 times the institutional upper limit of normal

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x the upper normal limit of institution's normal range, at the time of enrollment; for subjects with liver metastases, AST and ALT =< 5 x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia

Serum creatinine < 2 × upper limit of normal (ULN)

Serum potassium >= lower limit of normal (LLN)

STUDY TREATMENT: Serum bilirubin value less than 1.5 times the upper limit of the normal range

STUDY TREATMENT: Serum aminotransferase value less than 1.5 times the upper limit of the normal range

Must have had an elevated serum CA125 level twice the upper limit of normal (per reference lab normal range) measured within 4 weeks of enrollment.

Creatinine =< 1.5 x institutional upper limit of normal (ULN)

Serum creatinine < 1.5 x upper limits of normal (ULN)

Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within 5 times the upper limit of normal and a total serum bilirubin of less than 3 times the upper limit of normal, both of which define the upper limit of grade 2 treatment related toxicities

Serum creatinine < 140 umol/L (< 1.6 mg/dL) or 1.5 x the upper limit of normal, whichever is less

Creatinine =< 1.5 X institutional upper limit of normal

Creatinine =< 1.5 x institutional upper limit of normal (ULN), within 2 weeks of registration (except where specified otherwise)

Within 4 weeks prior to the registration: creatinine =< 2 X the upper limit of normal

Creatinine =< 2 x upper limit of normal (ULN)

Liver aminotransferase levels greater than 3 times the laboratory's upper limit of normal (greater than 5 times the laboratory's upper limit of normal if the liver is known to be involved with tumor)

Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN)

Creatinine =< 1.5 X upper limit of normal (ULN).

Serum creatinine < 2.0 x upper limit of normal

Serum creatinine ? 1.5 x institution’s ULN (upper limit of normal)

Hemoglobin within 10% of upper and lower limit of normal range of test (gender based)

Platelet within 10% of upper and lower limit of normal range of test

ALT < 2 x upper limit of normal

Prothrombin and partial thromboplastin times =< 1.2 x upper limit of normal (ULN) prior to biopsy

PRE-SCREENING: Must have normal organ function with liver function tests (LFTs) < 2.5 x upper limit of normal (ULN)

DONOR: ALT < 2 x upper limit of normal

Transaminase levels </=2.5 times the upper limit of normal (ULN)

Creatinine < 1.5 X institutional upper limit of normal

Potassium within institutional normal limit (WNL)

Serum creatinine within normal range

Creatinine =< 1.2 x normal range prior to biopsy

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < 5 x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia

Serum creatinine =< 1.5 x ULN (upper limit of normal)

Creatinine levels < 1.5 x upper limit of normal (ULN).

Creatinine =< 1.5 upper limit of normal (ULN)

Serum creatinine =< 1.5 x institution upper limit of normal (ULN)

Serum creatinine =< 1.5 x institution upper limit of normal (ULN)

Creatinine =< 1.5 x institutional upper limit of normal

Creatinine =< 1.5 X upper limit of normal (ULN)

Serum creatinine < 1.5 x upper limit of normal (ULN)

Plasma vascular endothelial growth factor (VEGF) > 2 x upper limit of normal (ULN)

Serum creatinine of < 3.0 x ULN (upper limit of normal)

Serum creatinine =< 2.0 X upper limit of normal (ULN)

Creatinine within 1.5 x upper limit of normal OR

Serum creatinine =< 1.5 x institutional upper limit of normal

PHASE II: AST (SGOT) =< 2.5 x institutional upper limit of normal

PHASE II: ALT (SGPT) =< 2.5 x institutional upper limit of normal

Completed within 10 days of SBRT treatment initiation: Serum creatinine =< 1.5 X upper limit of normal (ULN) OR

Serum creatinine =< 1.5 X upper limit of normal (ULN) OR

Creatinine =< 1.5 x institutional upper limit of normal

Alkaline phosphatase < 2.5 x upper limit of normal, unless bone metastasis is present (< 5 x upper limit of normal) in the absence of liver metastasis

PHASE II SCLC: AST (SGOT)/ALT (SGPT) =< 2.5 X institutional upper limit of normal (=< 5X ULN if liver mets)

UROTHELIAL CARCINOMA EXPANSION COHORT: AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (=< 5X ULN if liver mets)

mCRPC EXPANSION COHORT: AST(SGOT)/ALT(SGPT) =< 3 X institutional upper limit of normal (=< 5X ULN if liver mets)

Serum creatinine =< 1.5 X institutional upper limit of normal (ULN)

Adequate organ function =< 21 days prior to registration:\r\n* Aspartate transaminase (AST) level =< 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) =< 3 x upper limit of normal (ULN)\r\n* Total bilirubin level of =< 1.5 x ULN\r\n* Creatinine level =< 1.2 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above or below the institutional normal\r\n* Hemoglobin (Hgb) >= 9 g/dl without transfusion or epoetin dependency (=< 7 days prior to assessment)\r\n* Absolute neutrophil count >= 1.5 x 10^9/L\r\n* Platelets >= 100 x 10^9/L\r\n* Albumin >= 2.5 g/dl

Adequate renal function, as indicated by creatinine =< 1.5 x the upper limit of normal (ULN)

Serum creatinine < 1.5 x age-adjusted upper limit of normal (ULN)

Serum potassium >= institutional lower limit of normal (ILLN)

Serum creatinine of =< 1.5 x the upper limit of normal

Serum creatinine ? 1.5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) and bilirubin ? 1.5 times upper limit of normal

Obtained =< 14 days prior to registration: Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine =< 1.5 x upper limit of normal OR

AST and ALT =< 2 x institutional upper limit of normal

Prothrombin time =< 1.5 x upper limit of normal (ULN) obtained within 14 days of first treatment

AST or ALT >= 3 x ULN (upper limit of normal)

Potassium >= lower limit of normal

PHASE I: Creatinine < 1.5 x the institutional upper limit of normal (ULN)

Creatinine ? 2 times upper limit of normal

Transaminases (AST/SGOT and ALT/SGPT) ? 2.5 times upper limit of normal

Creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine =< 2.0 x upper limit of normal (ULN)

Serum creatinine less than or equal to 2 x upper limit of normal (ULN)

AST(SGOT)/ALT(SGPT) > 2.5 x institutional upper limit of normal

Renal impairment as evidenced by serum creatinine >1.5 × upper limit of normal (ULN)

Serum creatinine =< 2 x upper limit of normal (ULN)

Serum phosphorus >= lower limit of normal (LLN)

Creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine ?1.5 × upper limit of normal (ULN) for institution

Serum creatinine concentration < 3 x the upper limit of normal (ULN) based on the age of the patient

Adequate liver function as defined below: \r\n• Serum Bilirubin < 1.5 x upper limit of normal (ULN) for institution [Exception: Patients who have elevated serum bilirubin due to underlying Gilbert’s Syndrome or familial benign unconjugated hyperbilirubinemia are allowed.] \r\n• AST (SGOT) < 2.5 x upper limit of normal (ULN) for institution (or < 5.0 x ULN in presence of liver metastases) \r\n• ALT (SGPT) < 2.5 x upper limit of normal (ULN) for institution (or < 5.0 x ULN in presence of liver metastases)

Serum creatinine of =< 1.5 times upper limit of normal

Transaminases =< 2 x upper limit of normal (ULN) or if liver metastases were present, =< 3 x ULN

Serum creatinine =< 1.5 X institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment)

Serum aspartate aminotransferase (AST) < 5 x institutional upper limit of normal (IULN)

Serum creatinine value of =< 1.5 times the upper limit of normal (ULN)

Serum creatinine ? 1.5 x upper limit of normal (ULN) or

Transaminases (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x upper limit of normal (ULN)

Serum creatinine =< 1.5 x upper limit of normal

AT THE TIME OF INFUSION: Serum creatinine ? 2x upper limit of normal for age

Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN), CTCAE version 4 grade 1

Creatinine =< 1.5 x institutional upper limit of normal

Serum creatinine less than or equal to 1.5 x institutional upper limit of normal for age

Creatinine levels < 1.5 x upper limit of normal (ULN)

Liver function tests > 3 x upper limit of normal

Aspartate transaminase (AST) =< 2.5 x upper limit of normal (ULN)

Creatinine =< 1.5 x upper limit of institutional normal (ULN)

RESEARCH PHASE INCLUSION CRITERIA: In patients with suspected liver disease, AST and ALT must be =< 2.5 times institutional upper limit of normal (ULN)

Creatinine =< 1.5 x institutional upper limit of normal

EXCLUSION CRITERIA FOR ENROLLMENT: Creatinine >= 2.5 times the upper limit of normal (ULN)

Creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine < 2 times the upper limits of normal (ULN)

Liver function test (LFTs) =< 2 x upper limit of normal

Serum creatinine =< 1.2 x the upper limit of normal (ULN) prior to biopsy

TREATMENT: Patients with a creatinine ? 2 x upper limit of normal for age

Creatinine (Cr) =< 1.5 X upper limit of normal (ULN)

Biochemistry: Total bilirubin* ? institutional upper limit of normal Alkaline phosphatase ? 2.5 x institutional upper limit of normal AST(SGOT) and ALT(SGPT) ? 2.5 x institutional upper limit of normal Creatinine Clearance ? 40 ml/min * excluding Gilbert's syndrome Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula: Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in ?mol/L Males: GFR = 1.23 x (140-age) x weight in kg serum creatinine in ?mol/L

PART 2: Transaminases must be < 3 x the upper limit of normal

Creatinine =< 2.0 x upper limit of normal (ULN)

Serum creatinine < 1.5 times the upper limit of normal

Serum creatinine > 1.5 times the upper limit of normal

Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)

Serum creatinine =< 1.5 x the institutional upper limit of normal

plasma creatinine ? 1.5 x upper limit of normal (ULN) for the institution

Serum creatinine =< 1.5 times the upper limit of normal (ULN) (normal: =< 1.17 mL/min/1.73 m^2)

Serum creatinine =< 1.5 x upper limit of normal (ULN)

AST and ALT <5x upper limit of normal

Serum creatinine of =< 1.5 × upper limit of normal

Magnesium >= the lower limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN)

C. Renal: Serum creatinine (sCr) ? 1.5 x upper limit of normal.

Creatinine < 1.5 X upper limit of normal (ULN) or

Serum phosphorus >= lower limit of normal (LLN)

Aspartate aminotransferase (AST) < 1.5 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal)

Transaminases > 5x upper limit of normal for age

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine =< 2.0 x upper limit of normal (ULN)

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Patients who test positive for hepatitis C (HepC) antibodies (Ab) are eligible provided all of the following criteria are met: bilirubin =< 2 x upper limit of normal; ALT/AST =< 3 x upper limit of normal; and clinical evaluation to rule out cirrhosis

Serum alanine aminotransferase (ALT) less than three times the upper limit of normal (Turnstile II)

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.

Serum creatinine concentration, 1.5 times greater than the upper limit of laboratory normal ranges (ULN), except if related to ALL/LBL,

Newly diagnosed MCL: AST (SGOT) and ALT (SGPT) < 2 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present

Creatinine =< 1.5 X institutional upper limit of normal (ULN)

Serum potassium >= lower limit of normal (LLN)

Serum creatinine =< 1.2 times the upper limit of normal

Serum creatinine < 3 x upper limit of normal for age

AST less than 5 times the upper limit of normal

Serum creatinine less than 3 times the upper limit of normal

Creatinine =< 2 times upper limit of normal

Serum creatinine < 1.5 times upper limit of normal

Serum creatinine =< 1.5 x institutional upper limit of normal (IULN)

Serum glutamate pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN) or 5 x ULN if related to MF or MDS/MPN associated liver infiltration

Serum alanine transaminase (ALT) less than three times the upper limit of normal (Turnstile II)

Patients must have normal organ and marrow function as defined below: leukocytes > 3,000/mcL; absolute neutrophil count >1,500/mcL; platelets > 100,000/mcL, total bilirubin < or = 2.0 mg/dL. (Does NOT apply to patients with Gilbert's Syndrome); AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal (patients with liver involvement will be allowed < or = 5.0 X institutional upper normal limit) serum creatinine < 2.0 mg/dL

AST/ALT ? 2.5 times upper limit of normal (ULN)

Creatinine =< 2 x upper limit of normal

Blood urea nitrogen (BUN) less than 2 x upper limit of normal

Creatinine less than 1.5 x upper limit of normal

Serum bilirubin < 2 mg/dL upper limit of normal (unless due to Gilbert's disease; patient with this disease should have a right upper quadrant ultrasound evaluation before treatment)

Serum creatinine < 1.5 times upper limit of normal

Patients must have normal organ function as defined below:\r\n* Serum creatinine < 2.0 x institutional upper limit of normal (ULN)\r\n* International normalized ratio (INR) < 1.5 x institutional ULN

Serum glutamic-oxaloacetic transaminase (SGOT) =< 2.5 × upper limit of normal of institution's normal range (ULN) (=< 5.0 × ULN with liver metastasis)

Creatinine less or equal to 3 x upper limit of normal (ULN)

Creatinine =< 2 x upper limit of normal for age

Creatinine =< 3 X upper limit of normal (ULN)

Creatinine =< 2 X upper limit of normal (ULN)

Creatinine =< institutional upper limit of normal

Liver enzymes < 3 fold the upper limit of normal

Partial thromboplastin time (PTT) must be =< 2 X upper normal limit of institution's normal range; subjects on anticoagulant (such as coumadin) must have a PTT =< 5 X upper normal limit of institution's normal range

Creatinine =< 2.0 mg/dL for patients over 18 years or =< 2.5 x institutional upper limit of normal (ULN) for age, measured prior to conditioning chemotherapy

Creatinine =< institutional upper limit of normal OR

Serum amylase =< 1.5 x institutional upper limit of normal

Serum lipase =< 1.5 x institutional upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine clearance >= 50 mg/dl OR serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine =< 1.5 times upper limit of institutional for age or

Patients with creatinine > 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease

Liver enzymes less than three times the upper limit of normal

Serum creatinine 1.5 times or less than upper limit of normal

Amylase =< 2 x upper limit of normal

Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values >= 2.5 times the upper limit of normal based on age-specific normal values; if the abnormal liver function is attributable to liver involvement by malignancy, patients may be eligible with serum ALT and AST values up to 5.0 times the upper limit of normal, provided the patient has no evidence of impending hepatic failure (encephalopathy or prothrombin time > 2 times the upper limit of normal)

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine =< 2 x upper limit of normal

Serum creatinine less than 1.5 times the upper limits of normal within 7 days prior to starting treatment

Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN)

Transaminases less than or equal 3 x upper limit of normal unless related to the disease

Serum alanine aminotransferase (ALT) less than three times the upper limit of normal (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria)

Liver: transaminases < 5 x upper limit of normal and bilirubin < 3 x upper limit of normal

Serum creatinine < 1.5 x upper limit of normal

serum CA-125 level ?2x upper limit of normal (ULN) (in screening)

Alanine aminotransferase level less than or equal to (<=) 2.5* the upper limit of normal (ULN),

Screening Laboratory Values Hemoglobin ? 9g/dL White blood cell count ? 3,500 cells/mm3 Absolute neutrophil count ? 1,500 cells/mm3 Total bilirubin ? 2 times upper limit of normal Serum AST and ALT ? 2.5 times upper limit of normal Serum creatinine concentration ? 2mg/mL Pregnancy test: negative for females of childbearing potential

AST/SGOT and ALT/SGPT ?2.5×ULN. (upper limit of normal)

AST/ALT ? 3 times institutional upper limit of normal (except in patients with leukemic infiltration of liver)

SGOT (AST)<3x upper limit of normal

Bilirubin and creatinine less than 2 × upper limit of normal (ULN) for the institution

Evidence of abnormal liver function (serum ALT level(s) > 5 times upper limit of normal at screening or creatinine levels >2 times upper limit of normal at screening);

Patients with PT/PTT above the upper limit of normal

Serum creatinine ? 1.5 x upper limit of normal (ULN)

Magnesium >= the lower limit of normal

PT and PTT < 1.25 times the institutional upper limit of normal.

ALT (SGPT): < 2.5 X institutional upper limit of normal

Creatinine: < 1.5 x institutional upper limit of normal

Adequate liver function defined by a bilirubin value ?2 times the upper limit of normal (ULN), and transaminases (AST and ALT) values ?2.5 times ULN

Renal insufficiency (creatinine clearance < 40 ml/min) or liver insufficiency (serum bilirubin > 2 times the upper normal range and/or serum transaminases (AST/SGOT, ALT/SGPT, but not gamma Glutamyl Transpeptidase) >3 times the upper normal range). Creatinine clearance may be calculated according to validated formulas (Crockoft's or MDRD)

AST and/or ALT ?2.5 times upper limit of normal (ULN)

AST & ALT ? 5 x the upper limit normal

ALT/AST <2.5 times the upper limit of normal (ULN)

AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional upper limit of normal (ULN) or less than or equal to 5.0 x ULN in patients with liver metastases

Renal function: creatinine ? 1.5 x institutional upper limit of normal (ULN);

Within 14 days prior to registration: Serum creatinine =< 1.5 x upper limit of normal (ULN)

9. Adequate organ function as defined by the following: \r\na. Serum creatinine =< 2 x the upper limit of normal (ULN), or glomerular filtration rate > 20 ml/hour (h) as calculated by Cockcroft-Gault formula.\r\nb. Serum potassium, magnesium, and calcium (corrected for albumin) within institutional normal limits or can be corrected with supplementation.\r\nc. Total serum bilirubin =< 2.5 x ULN.\r\nd. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =< 2.5 x ULN.

Creatinine =< 1.5 X institutional upper limit of normal

Serum creatinine ? 1.5x upper limit of normal

SGPT (ALT) and SGOT (AST) < 3 x upper limit of normal (for ALT, the upper limit of normal for all sites is defined as 45 U/L)

Creatinine =< 1.5 x upper limit of normal (ULN) OR >= 60 mL/min

Serum creatinine ? 1.5 X upper limit of normal (ULN)

Transaminases must be < 3 x the upper limit of normal per reference values of treating institution

DONORS: Platelets within 10% of upper and lower limit of normal range of test (gender based for hemoglobin)

DONORS: ALT < 2 x upper limit of normal

Obtained within 28 days prior to registration: Alkaline phosphatase =< 2.5 x upper limit of normal, unless bone or liver metastasis is present (=< 5 x upper limit of normal)

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine =< 4 X institutional upper limit of normal

Creatinine =< 1.5 x institutional upper limit of normal

Liver function tests > 3 x upper limit of normal

Creatinine greater than or equal to 1.5 x upper limit of normal (ULN)

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine < 3 x upper limit of normal (ULN)

Creatinine =< 1.5 x upper limit of normal (ULN) or

Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN)

Sodium >= the institutional lower limit of normal

TREATMENT: AST (SGOT)/ALT (SGPT) =< 3 x institutional upper limit of normal

Serum creatinine =< 1.5 x upper limit of institutional normal

DOSE EXPANSION COHORT: AST(SGOT) ? 2.5 X institutional upper limit of normal (ULN)

Creatinine =< institutional upper limit of normal OR

Serum creatinine =< 1.5 x institutional upper limit of normal

Creatinine =< 1.5 x upper limit of normal (ULN)

Note: ULN is institutional or laboratory upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine =< 1.5 mg/dL x the institutional upper limit of normal

Renal disease: serum creatinine > 2 times upper limit of normal

Secondary Registration: AST (SGOT)/ALT (SGPT) =< 2.0 x institutional upper limit of normal

Secondary Registration: serum creatinine =< 1.5 x institutional upper limit of normal

Serum creatinine =< 1.5 x institutional upper limit of normal

Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 for subjects with above normal aspartate aminotransferase (AST) and alanine aminotransferase (ALT) with alkaline phosphatase within < 1.5 times upper limit of normal

Magnesium >= lower limit of normal (LLN) and =< ULN

Serum phosphorus >= lower limit of normal

Calcium >= lower limit of normal

Magnesium >= lower limit of normal

Potassium >= lower limit of normal

Patients must have serum direct bilirubin =< 2.0 mg/dl and transaminases =< 3x institution upper limit of normal

Serum creatinine < 1.5 times the upper limit of normal

Subjects must have normal organ and marrow function as defined below:\n\n               1. Absolute neutrophil count ? 1500/cmm\n\n               2. Platelets ? 100,000/cmm\n\n               3. Total bilirubinwithin normal limits of the institution\n\n               4. AST/ALT ? 2.5 X institutional upper limit of normal (ULN) or ? 5 X institutional\n                  upper limit of normal (ULN) in the presence of liver metastases\n\n               5. Creatinine ? 1.5 X institutional upper limit of normal (ULN)

Serum creatinine < 1.5 x the institutional upper limit of normal

At least one of the following clinical, laboratory, or imaging parameters:\r\n* Mild or moderate ascites\r\n* Serum bilirubin >= 3 mg/dl but less than 6 mg/dl\r\n* Aspartate aminotransferase (AST) > 5 times upper limit of normal (ULN) but =< 10 times ULN\r\n* Alanine aminotransferase (ALT) > 5 times upper limit of normal (ULN) but =< 10 times ULN\r\n* International normalized ratio for prothrombin time (INR) >1.5 but =< 2.5\r\n* Bland portal vein thrombosis (branch or main)\r\n* Functioning transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunt

AST > 10 times upper normal limit

ALT > 10 times upper normal limit

Transaminases < 2.5 x upper limit of normal

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 × the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < 5 × the upper normal limit of institution's normal range AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia

Transaminases < 5.0 x upper limit of normal (ULN)

Creatinine =< 2 X institutional upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN) OR

Creatinine =< 2.5 x institutional upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal and/or creatinine clearance > 50% lower limit of normal

Serum lipase =< upper limit of normal

Serum amylase =< upper limit of normal

DONOR: ALT < 2 x upper limit of normal

Creatinine =< 1.5 x upper limit of normal (ULN)

PHASE II: AST (SGOT)/ALT (SGPT) =< 3 X institutional upper limit of normal (ULN) or =< 5 X ULN if the patient has liver metastases

Creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine =< 1.5 X institutional upper limit of normal OR

Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) of the institutional normal reference range

Serum creatinine =< the institutional upper limit of normal

Aspartate amino transferase (AST) or alanine amino transferase (ALT) >= 2.5 times the upper limit of normal (if related to liver metastases >= five times the upper limit of normal)

Creatinine < 1.5 x institutional upper limit of normal OR

With impaired renal function as evidenced by creatinine-clearance < 50% for age, weight, height or serum creatinine > 2 x upper limit of normal or dialysis-dependent

Serum creatinine =< 1.5 times the institutional upper limit of normal

Serum creatinine less than 3 times upper limit of normal

Adequate hepatic function, with serum ALT ? 3times the upper limit of normal and\n             serum direct bilirubin ? 2 mg/dL (34 µmol/L) within 14 days prior to randomization

Serum creatinine =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatment

Serum ALT and AST less than three times the institutional upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal

Magnesium >= the lower limit of normal

Transaminases < 2.5 x upper limit of normal (up to 5 x upper limit of normal [ULN] in patients with liver metastases)

Creatinine =< 2 times upper limit of normal

Creatinine =< 1.5x upper limit of normal

Regimens I and II: Creatinine =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1\r\n* Regimen III: Creatinine no greater than the institutional upper limits of normal

Serum creatinine =< 2 x upper limit of normal

Serum creatinine less than 3 times upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal

Serum creatinine > 1.5 x upper limit of normal

AST and ALT > 2 x upper limit of normal

Creatinine < 1.5 x institutional upper limit of normal (IULN)

Serum creatinine =< 1.5 x upper limit of normal

Serum creatinine >= 1.5 x upper limit of normal

AST and ALT >= 2 x upper limit of normal

Serum creatinine < 2 x the upper limit of normal

Creatinine (non-isotope dilution mass spectrometry [IDMS]) =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1

Creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine =< 2 x institutional upper limit of normal (IULN), unless due to lymphoma, within 42 day prior to registration

Serum creatinine =< 1.5 times upper limit of normal (ULN) OR creatinine clearance (measured via 24-hour urine collection) >= 40 mL/minute

INR < 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry

Serum creatinine =< 1.5 x upper limit of normal (ULN)

A serum creatinine of ?1.5 x Upper Limit of Normal ULN OR

Serum creatinine < 1.5 X upper limit of normal (ULN) (institutional)

AST and ALT ? 2.5 times the upper limit of normal (ULN)

AST and ALT ? 2.5 times the upper limit of normal (ULN)

AST/ALT =< 3 X upper limit of normal (ULN)

Serum phosphorus >= lower limit of normal (LLN)

AST (SGOT), ALT (SGPT) ? 2.5 x upper limit of normal (ULN),

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)

Serum potassium and magnesium levels above the lower limit of normal

Creatinine =< 1.5 times the upper limit of normal (ULN)

Creatinine =< 2.0 x upper limit of normal (ULN)

Transaminases < 3x upper limit of normal

Creatinine =< 1.5 x upper limit of normal

Within 56 days prior to randomization: Serum creatinine =< 1.5 times upper limit of normal (ULN)

Serum creatinine =< 1.5 x upper limit of normal (ULN) OR

AST and ALT ? 5 times upper limit of normal (ULN)

Aspartate transaminase (AST) level ? 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ? 2.5 × upper limit of normal (ULN). For patients with liver metastases, AST ? 5 ULN, and AST ? 5 ULN may be enrolled if agreed upon by the investigator and medical monitor for the sponsor.

Serum creatinine < 2.5 x the upper limit of normal (ULN)

Patients must have adequate organ function: a) Bone marrow reserve: ANC ? 1.5 x 109/L, platelets ? 100 x 109/L, hemoglobin ? 9 g/dL b) Cardiac: i) QTcF < 450 msec on at least 2 of 3 screening ECGs. On site determination of QTcF may be used for screening purposes ii) LVEF equal to or greater than the institutional lower limit of normal. LVEF must be evaluated within 7 to 10 days prior to beginning study therapy iii) Cardiac Troponin I within normal limit (as per local institution) c) Hepatic: Total bilirubin ? 1.5 x ULN, ALT, AST ? 3.0 x ULN OR ? 5.0 x ULN for patients with liver metastases d) Renal: Serum/plasma creatinine ? 1.5 x ULN, or for patients with serum/plasma creatinine > 1.5 ULN, creatinine clearance ? 50 mL/min Exclusion Criteria for Part B: The presence of any of the following will exclude the patient from the study:

Creatinine =< 1.5 x upper limit of normal (ULN) within 14 days prior to study registration

ALT (SGPT) and/or AST (SGOT) ? 3x upper limit of normal (ULN), or ? 4 x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis [EMH] related to MF);

Serum creatinine =< 2.0 mg/dL for patients over 18 years or =< 2.5 x institutional upper limit of normal (ULN) for age

AST or ALT ? 3 x the institutional upper limit of normal

ALT and AST< 5 X upper limit of normal

Serum creatinine ? 1.5 X upper limit of normal

AST/SGOT and ALT/SGPT ? 3 x upper limit of normal (ULN) or ? 5.0 x ULN if liver tumor is present.

Serum creatinine should be within normal limits as specified by institutional guidelines; for patients with serum creatinine > upper limit of normal, a 24-hour creatinine clearance will be performed and should be equal to or more than the lower limit of normal

Creatinine =< 2 times the upper limits of normal (ULN)

Creatinine =< 3 x upper limit of normal (ULN)

Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN)

Aspartate transaminase (AST) < 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ? 2.5 × upper limit of normal (ULN).

Serum creatinine ?1.5 X upper limit of normal (ULN)

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Patients must have adequate organ and marrow function as defined below: NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN

Serum creatinine =< 1.5 times the upper limit of normal

Creatinine =< 1.5 x the institutional normal upper limit

Creatinine =< 2.0 x institutional upper limit of normal

AST/ALT > 3 x upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Adequate renal function defined as serum creatinine ?3 times the institutional upper limit of normal (ULN)

AST/ALT ? 3X ULN (upper limit of normal)

Serum creatinine < 1.5 X institutional upper limit of normal

Creatinine =< 2 x institutional upper limit of normal if patient has chronic renal insufficiency and creatinine has been stable x > 4 months

AST/ALT =< 2 x upper limit of normal (ULN)

Serum creatinine 1.5 times or less than upper limit of normal

Creatinine =< 1.5 x upper limit of normal

AST =< 5 x upper limit of normal

Serum creatinine < 1.5 X ULN (the upper limit of normal)

Serum AST and ALT ? 2.5 x Institutional upper limit of normal (ULN)

Serum potassium ? Institutional lower limit of normal (LLN)

Serum creatinine within 3 times the upper limits of normal

Creatinine within 1.5 times of the institution's upper limit of normal (ULN)

Prior to cyclophosphamide and T cell infusions: creatinine >= 3.0 x upper limit of normal (ULN)

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

Creatinine < 2 x institution upper limit of normal OR

Serum creatinine =< 1.5 X upper limit of normal (ULN) (within 14 days of treatment initiation) OR

Serum creatinine < 1.5 times upper limit of normal; OR

Partial thromboplastin time =< 1.66 times upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN), should be performed within 28 days of treatment initiation, unless otherwise indicated OR

Serum creatinine > 3 times the upper limit of normal

Liver transaminases > 5-times the upper limit of normal

Creatinine =< 2.5 x upper limit of normal (ULN)

Creatinine (Cr) < 1.5 upper limit of normal (ULN)

Serum creatinine =< 2.0 x upper limit of normal (ULN)

Within 4 weeks of administration of study therapy: Lactate dehydrogenase (LDH) < 4 x upper limit of normal (ULN)

Creatinine =< 2 x institutional upper limit of normal

Creatinine > 1.5 x the upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Aspartate transaminase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN in patients with liver metastasis)

Creatinine =< 1.5 x upper limit of normal (ULN)

Magnesium >= the lower limit of normal

Serum bilirubin <=1.25 x upper limit of normal (ULN)( These values must be independent of growth factor support and stable for at least one week post transfusion)

Creatinine =< 1.5 x upper limit of normal (ULN); institutional norms are acceptable

Creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine < 2.0 times upper normal limit

Creatinine =< 2.5 x upper limit of normal (ULN)

Creatinine =< 2.0 x upper limit of normal (ULN)

Creatinine =< 1.5 times the upper limit of normal

Creatine kinase (CK) =< 2.5 times the upper limit of normal

Serum alanine aminotransferase (ALT) < 3.5 times the upper limit of normal within 30 days prior to cycle 1 day 1

Creatinine =< 2 x upper limit of normal (ULN)

AT THE TIME OF INFUSION: Creatinine ? 2 x upper limit of normal for age

AST ? 2.5 times upper limit of normal (ULN) (? 5 times ULN for patients with liver metastases);

Liver enzymes =< 2 times the upper limit of normal

Creatinine =< 1.5 x upper limit of normal (ULN)

Serum lipase =< upper limit of normal

Serum amylase =< upper limit of normal

Alkaline phosphates must be =< 2.5 X the upper limit of normal

Serum creatinine =< 1.5 times the upper limit of normal (ULN)

PHASE II: AST (SGOT)/ALT (SGPT) =< 2.5 x institutional upper limit of normal

Renal: Serum creatinine (sCr) ? 2.0 x upper limit of normal.

Creatinine < 2 x upper limit of normal (ULN)

Creatinine >= 3.0 x upper limit of normal (ULN)

Creatinine within 1.5 x the upper limit of normal (ULN) institutional limits

COHORT A: Creatinine =< 2.0 x upper limit of normal (ULN)

Adequate liver function defined as bilirubin =< 1.5 x upper limit of normal and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal

Participants with a serum potassium less than 3.5 mmol/L or a serum ionized calcium or magnesium below the lower limits of normal (or above CTCAE grade 1 upper limit); correction of these electrolyte abnormalities with supplements is allowed (serum calcium above the CTCAE grade 1 upper limit; in cases where the serum calcium is below the normal range, the calcium adjusted for albumin is to be obtained and substituted for the measured serum value; exclusion is to then be based on the calcium adjusted for albumin values falling below the normal limit)

Serum creatinine =< 2.5 x upper limit of normal

Planning to receive autologous HCT per institutional standards as part of standard of care. Eligibility for autologous HCT should be based on institutional guidelines. However, at minimum all patients must meet the following criteria:\r\n* Karnofsky performance status (KPS) greater than 70\r\n* Cardiac left ventricular ejection fraction of greater than 40%\r\n* Calculated creatinine clearance of greater than 40 cc/min\r\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of less than 2 x upper limit of normal\r\n* Direct bilirubin of less than 2 x upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum alanine aminotransferase (ALT) < 3.5 times the upper limit of normal within 7 days of time of consent

Serum creatinine =< 1.5 x the upper limit of normal

Creatinine =< 2 times the upper limits of normal (ULN)

Serum creatinine </=2x upper limit of normal

Serum creatinine =< 1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine =< 1.5 x the upper limit of normal range, or, if serum creatinine > 1.5 x the upper limit or normal range, then the creatinine clearance must be >= 60 mL/min

Serum creatinine > 2 x upper limit of normal

Magnesium >= the lower limit of normal for the institution

Obtained =< 7 days prior to registration: Serum amylase =< 1.5 x upper limit of normal (ULN)

Creatinine =< 1.5 x upper limit of normal (institutional ULN)

Patients must have WBC >/= 3.5 x 10^9/L, ANC >/= 1.5 x 10^9/L, platelets >/= 100 x 10^9/L, Hb >/= 9.0 g/dL); total bilirubin </= 1.5 x ULN, AST and ALT </= 1.5 x the upper limit of normal; serum potassium of >/= 3.5 mEq/L, serum albumin of >/= 3.0 g/dL, serum creatinine </= 1.5 x ULN

Magnesium at or above lower limit of normal (correction with supplements is fine as long as the resultant level is at or above the lower limit of normal)

AST/SGOT and ALT/SGPT =< 2.5 x upper limit of normal (ULN) if liver metastases are present

Serum creatinine =< 1.5 X institutional upper limit of normal

Serum creatinine =< 3 x upper limit of normal (ULN)

Creatinine =< 2.0 times the institutional upper limit of normal

Creatinine =< 1.5 x institutional upper limit of normal OR

Adequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (ULN) for the institution, bilirubin <=1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 x ULN).

SGOT(AST) and SGPT(ALT) < 3 x ULN (upper limit of normal)

Creatinine =< 1.5 x upper limit of normal (ULN)

Serum potassium >= lower limit of normal (LLN)

Transaminases must be < 3 x the upper limit of normal per reference values of referring institution

Transaminase > 3 x upper normal limit (UNL)

Serum creatinine < 2.0 x upper limit of normal (ULN)

Serum phosphorus >= lower limit of normal (LLN)

Creatinine > 2.0 times upper normal limit

ALT > 2.0 times upper normal limit (unless due to chronic GVHD)

AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

Creatinine =< 1.5 x upper limit of normal

Patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: 1. Serum creatinine </= 2.0 mg/dl. 2. Total bilirubin </= 1.5x the upper limit of normal unless considered due to Gilbert's syndrome. 3. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) </= 3x the upper limit of normal.

DONOR: ALT < 2 x upper limit of normal

Lipase < 2 x the upper limit of normal

Creatinine > 1.5 times the institutional upper limit of normal

Serum Creatinine =< 1.5 X the upper limit of normal (ULN)

Creatinine =< 2 x upper limit of normal (ULN)

Lipase < 1.5 x the upper limit of normal (except for participants with adenocarcinoma of the pancreas)

Serum phosphorus >= lower limit of normal (LLN)

Serum creatinine of =< 1.5 X the upper limit of normal

AST(SGOT)/ALT(SGPT) ? 2.5 X institutional upper limit of normal

Creatinine =< 2 X institutional upper limit of normal

Patients who test positive for hepatitis C antibody (Ab) are eligible provided all of the following criteria are met: 1) total bilirubin =< 2 x upper limit of normal; 2) AND aspartate aminotransferase (AST) =< 3 x upper limit of normal; AND 3) liver biopsy (pathology) demonstrates =< grade 2 fibrosis and no cirrhosis

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum lipase < 3 X institutional upper limit of normal

Transaminases < 3 times the upper limit of normal

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 × the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < 5 × the upper normal limit of institution's normal range are acceptable AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia; the combination of 5-FU and oxaliplatin is known to be safe to be administered in patients with such abnormal liver function tests

Non-fasting direct bilirubin =< 1.5 × the upper normal limit of institution's normal range; for subjects with liver metastases, non-fasting direct bilirubin > 1.5-3.0 x the upper normal limit of institution's normal range are acceptable AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia; the combination of 5-FU and oxaliplatin is known to be safe to be administered in patients with such abnormal liver function tests

Creatinine =< 1.5 x institutional upper limit of normal (ULN), CTCAE grade 1

Creatinine =< 3.0 x upper limit of normal (ULN)

Plasma creatine phosphokinase (CK) < 1.5 x upper limit of normal (ULN)

Within 14 days prior to registration: Creatinine =< 1.5 x upper limit of normal range

Creatinine =< 2.0 x upper limit of normal (ULN)

Lipase < 1.5 x upper limit of normal

Serum potassium >= lower limit of normal (LLN)

Creatinine: ~ 2 x upper limit or normal (ULN)

Creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine < 1.5 x upper limit of normal (ULN)

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine =< 2 times upper limit of normal

Meets criteria for poor-risk defined as 3 or more of the following: ECOG performance status 2, anemia (hemoglobin lower than reference range), elevated serum lactate dehydrogenase (LDH) > 1.5 x upper limit of normal (ULN), hypercalcemia (corrected serum calcium level > upper limit of normal), time from initial RCC diagnosis to registration on this trial < 1 year, and > 1 metastatic organ sites

Liver function tests (LFT's) =< 5 x upper limit of institutional normal (ULN)

AST(SGOT)/ALT(SGPT) ? 2.5 X institutional upper limit of normal

Creatinine =< 2 X institutional upper limit of normal

Serum creatinine within 1.5 x upper limit of normal (CTCAE 4.0 grade 1 abnormality is acceptable)

Creatinine phosphokinase (CPK) within 2.5 x upper limit of normal (CTCAE 4.0 grade 1 abnormality is acceptable)

Transaminases =< 5 x the upper limit of normal for age appropriate indices

Creatinine =< 2.5 x upper limit of normal (ULN)

Magnesium levels >= lower limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine =< 2 x upper limit of normal (ULN)

Serum potassium, magnesium and phosphorus >= lower limit of normal (LLN) and =< 1.2 x ULN

Creatinine =< 1.5 times upper limit of normal (ULN)

Serum creatinine =< 1.5 x institution upper limit of normal (ULN)

Magnesium level >= lower limit of normal

Creatinine =< 2 X upper limit of normal (ULN)

Creatinine =< 1.5 x upper limit of normal (ULN) for children and =< 2.0 x ULN for adults

EXPANSION COHORT ONLY: AST (SGOT)/ALT (SGPT) =< 2.5 X institutional upper limit of normal

Creatinine < 1.5 times upper limit of normal (ULN)

AST =< 2 x upper limit of normal

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine =< 1.5 x institutional upper limit of normal (ULN), obtained within 14 days prior to first treatment

Creatinine =< 3 x upper limit of normal (ULN)

Creatinine =< 1.5 times upper limit of normal (ULN)

Patients must have normal organ and marrow function as defined below: leukocytes >3,000/mcL; absolute neutrophil count >1,500/mcL; platelets >100,000/mcL; total bilirubin <1.5 X institutional upper limits of normal; AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal; Alkaline phosphatase (AP) <2.5 X institutional upper limit of normal; creatinine <1.5X institutional upper limit of normal OR creatinine clearance >50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

Asparate aminotransferase (AST) < 2 x the upper limit of normal

Creatinine =< 1.5 x upper limit of normal for the laboratory

Normal organ and marrow function as defined below: Absolute granulocyte count ? 1,500/mm3 Absolute lymphocyte count ? 500/mm3 Platelets ? 100,000/mm3 Total bilirubin ?2 mg/dL AST(SGOT)/ALT(SGPT) <2x institutional upper limit of normal Creatinine <1.5 mg/dL

Creatinine < 1.5 institutional upper limit of normal OR

Creatinine =< 2 x upper limit of normal for age

Blood urea nitrogen (BUN) < 1.5 times upper limit of laboratory normal

Serum creatinine < 1.5 times upper limit of laboratory normal

Renal Function: Patients must have serum creatinine ? 1.5 times upper limit of institutional normal for age and/or GFR ? 70 mL/min/1.73 m2.

Serum creatinine concentration < 3 X the institutional upper limit of normal (ULN)

Patients must have adequate bone marrow function (ANC = or > 1,500/mm^3 and platelet count of = or > 100,000/mm^3), adequate liver function (SGPT = or < 3 times upper limit of normal and alkaline phosphatase = or < 2 times upper limit of normal, bilirubin = or <1.5 mg/dl), adequate renal function (BUN and creatinine = or <1.5 times upper limit of normal) and normal serum amylase and lipase prior to starting therapy. Elevated cholesterol and triglycerides are not a contraindication to study enrollment, but should be managed as clinically appropriate by the treating physician.

Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values less than or equal to 2.5 times the upper limit of normal; patients with elevations of ALT or AST up to 10 times the upper limit of normal may be considered for participation if such elevations are thought to be due to liver involvement by malignancy; however, in these latter patients, if these values do not decrease to less than or equal to 2.5 times the upper limit of normal during induction chemotherapy, such patients will not be eligible for the transplant phase of the protocol, and will thus be taken off study

Creatinine < 2 times upper limit of normal

AST or ALT greater than 5 times upper limit of normal or greater than 250 U/l.

Active hepatitis or liver biopsy evidence of cirrhosis or periportal fibrosis; liver function tests: total bilirubin > 2 x the upper limit of normal and/or serum glutamic pyruvate transaminase (SGPT) and SGPT > 4 x the upper limit of normal

Serum creatinine =< 2 x upper limit of normal (ULN)

Creatinine less than or equal to 1.5 x upper limit of normal, CTCAE v 4.0 grade 1

Aspartate transaminase (AST) less than or equal to 2.5 x upper limit of normal, CTCAE v 4.0 grade 1

Serum aspartate aminotransferase and alanine amino-transferase of at least 5 times the upper limit of normal

Serum creatinine of at least 1.5 times the upper limit of normal

Adequate renal function [creatinine ? 1.5x ULN (upper limit of normal)] or GFR of ? 60mL/min.

ALT ? 5x ULN of normal for age.

AST(SGOT)/ALT(SGPT) <1.5 X institutional upper limit of normal

Creatinine =< 1.5 x upper limit of normal (ULN); either lab result or calculated clearance

Creatinine =< 1.6 x the upper limit of normal (ULN)

Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1

Transaminases > 3 times upper normal limit

Magnesium >= the lower limit of normal

Creatinine: =< 2.0 x upper limit of normal (ULN)

Serum creatinine =< 2 times the upper limit of normal

POST-TRANSPLANT ELIGIBILITY CRITERIA:\r\n* In complete remission (CR) (including incomplete blood count recovery [CRi] and marrow CR) on bone marrow biopsy for response assessment after HCT (typically day +30)\r\n* Patient is within 30-100 days after HCT\r\n* Absolute neutrophil count (ANC) >= 1000/uL, platelet count >= 20,000/uL\r\n* ECOG performance status 0-2\r\n* Adequate major organ function, as defined by AST and ALT =< 2 x upper limit of normal\r\n* Total serum bilirubin < 2 x upper limit of normal (unless due to hemolysis or Gilbert’s syndrome, then no upper limit)\r\n* Creatinine =< 2 x upper limit of normal unless there is known chronic kidney disease (CKD) (creatinine must be at baseline for subjects with CKD)\r\n* In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile

Serum creatinine > 2 x upper limit of normal, unless there is known CKD (creatinine must be at baseline for subjects with CKD)

AST or ALT > 2 x upper limit of normal

POST-TRANSPLANT EXCLUSION CRITERIA:\r\n* Active grade II-IV acute graft versus host disease (GVHD)\r\n* Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy\r\n* Serum creatinine > 2 x upper limit of normal unless there is known CKD (creatinine must be at baseline for subjects with CKD)\r\n* AST or ALT > 2 x upper limit of normal\r\n* Total bilirubin > 2 x upper limit of normal\r\n* History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent\r\n* Pregnancy\r\n* Concurrent use of any other investigational agents on a clinical trial\r\n* Known hypersensitivity to 5-azacytidine\r\n** Prior treatment with 5-azacytidine is allowed

Sodium >= 130 mg/dl and =< upper limit of normal

Potassium >= 3.0 mg/dl and =< upper limit of normal

Alkaline phosphatase < 2.5 times the upper limit of normal; in patients with liver metastasis, liver function tests should be < 5 times the upper limit of normal

Blood urea nitrogen (BUN) < 2.5 times the upper limit of normal

Creatinine < 2.5 times the upper limit of normal

Serum creatinine >= 2 x upper limit of normal

Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN)

AST/ALT ? 5 X upper limit of normal

Creatinine =< 1.5 x institutional upper limit of normal

Alkaline phosphatase < 2.5 x institutional upper limit of normal (in subjects with no liver metastasis and < 5.0 upper limit of normal [ULN] in subjects with liver metastasis)

Serum creatinine =< 1.5 the institutional upper limit of normal

Creatinine =< 1.5 X institutional upper limit of normal

Has adequate renal function as evidenced by serum creatinine ?2.5 × the upper limit of normal (ULN) for the reference lab;

Serum creatinine =< 1.5 x the upper limit of normal (ULN)

DONOR: ALT < 2 x upper limit of normal

Hepatic insufficiency (> 1.5 times the upper normal limit of transaminase levels)

NON-PROGRESSED DIPG (STRATUM 2): ALT(SGPT) =< 3 x institutional upper limit of normal

Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)

Serum creatinine less than 1.5 times the upper limits of normal

Creatine phosphokinase =< institutional upper limit of normal

Serum potassium >= lower limit of normal (LLN)

AST and ALT ?3 x upper limit of normal

Serum bilirubin levels =< 1.5 times the upper limit of the normal (ULN) range for the laboratory; higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis

Calcium: not above normal institutional limit

Creatinine =< 2.0 x upper limit of institutional normal for age

Serum creatinine >= 2 x upper limit of normal

Serum creatinine level > 1.5 x the upper limit of normal (ULN), chronic renal failure requiring hemodialysis or peritoneal dialysis.

Serum creatinine < 1.6 mg/dL. Serum bilirubin < 2X upper limit of normal.

SGPT < 2X upper limit of normal.

Electrolyte abnormality that has not responded to correction, including hypokalemia or hypocalcemia less than the lower limit of normal, or hyperkalemia or hypercalcemia greater than the upper limit of normal (ULN).

Serum creatinine (Cr) ? 1.5 x upper limit of normal (ULN).

Serum creatinine =< 1.5 x upper limit of normal or

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 X the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < 5 X the upper normal limit of institution's normal range AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia

Non-fasting bilirubin =< 1.5 X the upper normal limit of institution's normal range; non-fasting bilirubin 1.5 - 3.0 X the upper normal limit of institution's normal range are acceptable AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia

serum creatinine of ? 1.5x upper limit of normal (ULN) for the reference lab.

Patient's ALT must be < 5 x institutional upper limit of norm ULN.

Serum creatinine =< 1.5 x institution’s ULN (upper limit of normal), or

Creatinine < 1.5 x upper limit of normal (ULN)

Alkaline phosphatase =< 2.5 X upper limit of normal in the absence of liver or bone metastasis, or =< 5.0 x upper limit of normal range if bone or liver metastases

Creatinine < 1.5 x upper limit of normal (ULN)

Creatinine < 2 x upper limit of normal (ULN)

Serum creatinine =< 1.5 X institutional upper limit of normal

Inadequate renal function as indicated by serum creatinine >= 1.5 times the upper limit of normal

Serum creatinine >1.5 x ULN or calculated or directly measured CrCl < 50% lower limit of normal

LVEF above the institution's lower limit of normal

Alanine transaminase (ALT) ? 3 × institutional upper limit of normal (ULN) [? 5 × ULN in presence of liver metastases] within 14 days prior to randomization.

Adequate baseline organ function defined as: absolute neutrophil count >= 1.2 x 10^9/Liter (L); hemoglobin>=9 gram per deciliter (g/dL); platelets >= 75 x 10^9/L; prothrombin time /international normalized ratio and partial thromboplastin time =<1.3 x ULN; serum bilirubin=<1.5 times upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase =<2.5 times ULN; serum creatinine=<1.5 mg/dL or calculate creatinine clearance >= 50 milliliter per minute; Left ventricular ejection fraction>= lower limit of normal by echocardiography.

Serum creatinine < 1.5 × the upper limit of normal (ULN).

Creatinine =< 3 x institutional upper limit of normal

Creatinine =< 1.5 x institutional upper limit

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Creatinine (Cr) =< 1.5 x upper limit normal

Lipase < 1.5 x the upper limit of normal

Hepatic function: AST and ALT ? 2.5 × the upper normal limit of institution's normal range. For subjects with liver metastases, AST and ALT ? 5 × the upper normal limit of institution's normal range;

Serum chromogranin A level >5 x upper limit of normal and/or serum neuron specific enolase (NSE) >2x upper limit of normal

Serum alanine aminotransferase (ALT) =< 3.5 times the upper limit of normal within 14 days prior to randomization

Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3; Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine </= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) </= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of </= 5.0 x the upper limit of normal.

Creatinine < 1.5 X Upper Limit of the Normal (ULN)

Magnesium >= the lower limit of normal

Serum creatinine < 2 x institutional upper limit of normal OR

LDH < 1.50 X institutional upper limit of normal

ALT or AST ? twice the upper limit of normal (ULN), unless considered due to organ leukemic involvement;

Serum creatinine =< 1.5 x upper limit of normal (ULN)

AST, SGOT, ALT, SGPT ? 2.5 X upper limit of normal, < 5 upper limit if there are liver metastases

Serum potassium >= lower limit of normal (LLN)

SGPT (ALT) ? 135 U/L and SGOT (AST) ? 3X ULN. (for the purpose of this study, the upper limit of normal [ULN] for SGPT [ALT] is 45 U/L).

INR and aPTT < 1.2 times upper limit of normal for age.

Creatinine ? 3 times the upper limit of normal (ULN)

Lactate dehydrogenase (LDH) ? 2 times the upper limit of normal (ULN).

Serum creatinine < 1.5 upper limit of normal (ULN)

Creatinine =< 1.5 x upper limit of normal (ULN), within 14 days prior to initiation of study drug

Magnesium >= lower limit of normal (=< 48 hours prior to registration)

Calcium >= lower limit of normal (=< 48 hours prior to registration)

Creatinine needs to be less than or equal to 1.3 x upper limit of normal (ULN)

Serum potassium >= lower limit of normal (LLN)

AST and ALT </= 3x the upper limit of normal

PT and aPTT each < 1.5 times the upper limit of normal.

Creatinine =< 2.0 mg/dL (< 2 x upper limit of normal [ULN])

ALT < 2.5 X institutional upper limit of normal

AST < 2.5 X institutional upper limit of normal

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]

Serum creatinine =< 1.5 x upper limit of normal (ULN) for age

Patient has adequate hepatic function (serum bilirubin values <2.0 mg/dL and ALT and/or AST values <3 × the upper limit of normal ULN).

Creatinine =< 3.0 x upper limit of normal (ULN)

Magnesium >= the lower limit of normal

Creatinine =< 1.5 x institutional upper limit of normal (ULN), CTCAE grade 1

Adequate hepatic function, with serum ALT ? 3.5 times the upper limit of normal and serum direct bilirubin ? 2 mg/dL (34 µmol/L) within 21 days prior to randomization

Serum creatinine of =< 1.5 X the upper limit of normal

Adequate renal function, as indicated by creatinine =< 1.5 x upper limit of normal (ULN)

ALT and AST > 2.5 X upper limit of normal

Creatinine > 1.5 X upper limit of normal.

Creatinine =< 3 x upper limit of normal (ULN)

Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)

Magnesium ? lower limit of normal (LLN)

SGOT (AST) < 3x upper limit of normal.

Hepatic: serum bilirubin less than 2x upper limit of normal for age as per local laboratory) (with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome), alanine transaminase (ALT) and aspartate transaminase (AST) less than 4x upper limit of normal for age (as per local laboratory)

Renal: serum creatinine less than 2x upper limit of normal for age (as per local laboratory)

AST/ALT =< 2.5 x upper limit of normal (ULN)

Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN)

Serum creatinine =< 1.5 x upper limit of normal (ULN) OR

Serum bilirubin < 1.5 x upper limit of normal (ULN) (maximum level based on MD Anderson laboratory ranges is 1.95 mg/dL)

Creatinine =< 2.0 x upper limit of normal (ULN)

Magnesium >= the lower limit of normal

Creatinine =< 1.5 x upper limit of normal (ULN)

Creatine phosphokinase (CPK) =< the institutional upper limit of normal

LVEF that is ?50% (or ? institutional lower limit of normal);

Creatinine < 1.5 x institutional upper limit of normal (ULN)

Renal insufficiency, defined as creatinine level greater than the upper limit of normal for age

Grade 2 renal dysfunction: creatinine > 2-3 times the upper limit of normal

Performed within 10 days of treatment initiation: Creatinine =< 1.5 x upper limit normal (ULN) OR

AST/(SGOT)/ALT(SGPT) =< 3.0 x institutional upper limit of normal (ULN) (=< 5.0 x institutional ULN with documented liver metastases)

Serum creatinine =< upper limit of normal (ULN)

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)

Subjects who have a serum creatinine > 2 x upper limit of normal (ULN)

Creatinine < 1.5 times the upper limit of normal, or:

Serum creatinine =< 2.5 x upper limit of normal (ULN) (within 7 days)

Creatinine < 1.5 x upper limit of normal (ULN) OR

Alk phosphatase =< 3 times institutional upper limit of normal

Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal

Creatinine =< 1.5 x upper limit of normal (ULN)

Alanine aminotransaminase (ALT) < 5 x upper limit of normal (ULN)

AST < 3 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal)

Serum creatinine =< 2 times the upper limit of normal

Creatinine =< 2 x upper limit of normal (ULN)

Serum creatinine must be < 1.5 times the upper limit of the institutional normal range; test results must be no more than 3 months old

Creatinine =< 1.5 x the upper limit of normal (ULN)

Serum creatinine < 1.5 times the upper limit of normal

Minocycline trial only: patients with adequate renal function according to MD Anderson testing standards (screening cut off for serum creatinine < 2 times the upper limit of normal)

Minocycline trial only: screening results for alanine aminotransferase (ALT), if available, must be < 3 times the upper limit of normal

Serum creatinine < institutional upper limit of normal (ULN)

Abnormal renal function (serum creatinine level > 2X upper limit of normal [ULN]) as assessed by the central laboratory during screening.

Serum creatinine =< 2 x upper limit normal

Creatinine < 3.0 x upper limit of normal (ULN)

Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN)

Hypercalcemia (serum calcium in excess of laboratory upper limit of normal [ULN])

Creatinine ? 1.5 x upper limit of normal (ULN) of institution's range or Creatinine clearance ? 50%

Blood urea nitrogen < 2 x upper limit of normal (ULN)

Creatinine =< institutional upper limit of normal (ULN)

Aspartate aminotransferase < 3 times upper limit of normal value

Alanine aminotransferase < 3 times upper limit of normal value

SGOT (AST) or SGPT (ALT) < 5.0 x upper limit of normal

Normal renal function as determined by a serum creatinine < upper limit of normal

Serum creatinine within 1.5 x upper limit of institutional normal

AST and ALT <10x upper limit of normal

Creatinine =< 2.5 x institutional upper limit of normal (ULN) obtained =< 45 days prior to randomization

Hemoglobin greater than 90% of the lower limit of institutional normal

Blood urea nitrogen (BUN) =< 1.5 x institutional upper limit of normal

Creatinine =< 1.5 x institutional upper limit of normal

Serum creatinine > 2.5 x ULN (upper limit of normal)

Creatinine =< 1.5 x the institutional upper limit of normal (ULN), obtained within 14 days prior to treatment start

Creatinine =< institutional upper limit of normal OR

Within 30 days of eligibility confirmation: Creatinine not above the upper limit of normal institutional limits

Measured within 28 days prior to administration of study treatment: Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)

Creatinine =< twice upper limit institutional normal

AST, ALT ? 2.5 x upper limit of normal

AST/SGOT and ALT/SGPT ?2 x Upper Limit of Normal (ULN)

Serum creatinine ? 1.5 x upper limit of normal (ULN) for age

Transaminases =< 2.5 x institutional upper limit of normal (IULN)

Hypercalcemia (serum calcium in excess of laboratory upper limit normal [ULN])

Sodium, potassium, chloride, bicarbonate: all =< upper limit of institutional normal

Fasting triglycerides =< 1.5 x upper limit of normal (ULN)

Na within 2 x upper limit of normal (ULN)

Transaminases =< 2.5 x institutional upper limit of normal (IULN)

Creatinine =< 2.0 times the upper limit of normal

Magnesium, potassium and calcium < the lower limit of normal per institution normal lab values

Serum creatinine > 1.5 times upper reference range

Magnesium > the lower limit of normal per institution normal lab values

Potassium > the lower limit of normal per institution normal lab values

Calcium > the lower limit of normal per institution normal lab values

Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)

SUB-STUDY I: Serum creatinine > 2 time the upper limit of normal

SUB-STUDY I: Liver transaminases > 5 times the upper limit of normal

SUB-STUDY II: Serum creatinine > 2 time the upper limit of normal

SUB-STUDY II: Liver transaminases > 5 times the upper limit of normal

SUB-STUDY III: Serum creatinine > 3 times the upper limit of normal

SUB-STUDY III: Liver transaminases > 5 times the upper limit of normal

Serum creatinine > 2 times the upper limit of normal

Serum creatinine > 2 times the upper limit of normal

Creatinine > 2 x upper limit of normal

Creatinine =< 1.5 x the institutional upper limit of normal

Serum creatinine > 1.5 times upper limit of normal

Serum creatinine > 3 times the upper limit of normal

Liver transaminases > 5 times the upper limit of normal

Amylase less than 4.0 times below or above the upper or lower limit range

Albumin less than 4.0 times below or above the upper or lower limit range

Sodium less than 4.0 times below or above the upper or lower limit range

Potassium less than 4.0 times below or above the upper or lower limit range

Chloride less than 4.0 times below or above the upper or lower limit range

Bicarbonate (HCO3) less than 4.0 times below or above the upper or lower limit range

Calcium less than 4.0 times below or above the upper or lower limit range

Phosphorus less than 4.0 times below or above the upper or lower limit range

Creatinine less than 4.0 times below or above the upper or lower limit range

Glucose less than 4.0 times below or above the upper or lower limit range

Prothrombin time less than 4.0 times below or above the upper or lower limit range

Serum creatinine =< 1.5 times upper reference range

Serum ferritin < 2.0 X institutional upper limit of normal

Liver function tests (LFTS) =< 1.5 x upper limit of normal (ULN)

Serum ferritin < 2.0 X institutional upper limit of normal

Serum electrolytes less than 4.0 times below or above the upper or lower limit range

Prothrombin time less than 2.5 times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time must not exceed 6 times the upper limit of the normal range

Partial thromboplastin time less than 2.5 times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for partial thromboplastin time must not exceed 6 times the upper limit of the normal range

Creatinine less than 4.0 times below or above the upper or lower limit range

Magnesium, potassium and calcium > the lower limit of normal per institution normal lab values

Magnesium >= the lower limit of normal per institution normal lab values

Potassium >= the lower limit of normal per institution normal lab values

Calcium >= the lower limit of normal per institution normal lab values

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum creatinine =< 2 x upper limit of normal (ULN)

Serum lipase =< upper limit of normal (IULN)

Serum potassium and serum magnesium ? institutional lower limit of normal (LLN).

Subjects must have adequate renal function as defined by serum creatinine < 1.5 x upper limit of normal

Magnesium, potassium and calcium > the lower limit of normal per institution normal lab values

Absolute neutrophil count (ANC) >= 4.0 X upper limit of normal (ULN) or lower limit of normal (LLN)

Serum creatinine =< institutional upper limit of normal (IULN)

Creatinine >= 1.5 times upper limit of normal

Creatinine >= 1.5 times upper limit of normal

Serum creatinine > 2 times the upper limit of normal

Aspartate aminotransaminase (AST) =< 2.5 x upper limit of normal (ULN)

Significant history or current renal insufficiency (serum creatinine > 1.5 institutional upper limit of normal)

Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ? 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ? 2.5 x upper limit of normal, alkaline phosphatase ? 2.5 x upper limit of normal and total bilirubin ? 2.0 x upper limit of normal).

Serum creatinine > 1.5 x upper limit of normal (ULN)

Creatinine =< 1.5 times the institution upper limit of normal (ULN)

Creatinine > 1.5 times the institution upper limit of normal (ULN)

Cardiac troponin (cTn) levels above the upper limit of normal

Participants must have serum calcium (corrected for albumin level) =< 1 x institutional upper limit of normal (ULN)

PT and PTT ? 1.5 times the upper limit of normal

Patients should have adequate hepatic function with a total bilirubin within normal range and serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) < two times the upper limit of normal (ULN) for patients without liver metastasis and SGOT or SGPT < five times ULN for those with liver metastasis, and adequate renal function as defined by a serum creatinine within 1.5 times the upper limit of normal.

Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN) (=< 5 x ULN acceptable for pancreatic subjects with known liver metastasis only)

Serum creatinine =< 1.5 x upper limit of normal (ULN)

Serum potassium between the institution’s lower limit of normal and 5.5

Have a serum creatinine above 1.5 upper limit of normal (ULN) (collected within the past 4 weeks); ULN is per institutional definition

AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal

alanine aminotransferase <3x upper limit of normal for age (<135 U/mL)

bilirubin ? 1.5 mg/dL; alanine aminotransferase (ALT), aspartate transaminase (AST) ? 2.5 times the upper limit of normal if no liver involvement or ? 5 times the upper limit of normal with liver involvement.

Patients must have adequate hepatic and renal function as evidenced by bilirubin 2.0 times the upper limit of the normal range (ULN) or lower, alanine aminotransferase (ALT) and asparate aminotransferase (AST) 3 times the ULN or lower, serum creatinine 1.5 times the ULN or lower. Patients with nonclinically significant elevations of bilirubin up to 5.0 g/dL (85500 ?mol/L) due to known or suspected Gilbert's disease are eligible; this must be documented on the medical history page of the case report form (CRF).

AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal

AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal

Serum creatinine ? 1.5 x upper limit of normal (ULN).