Absolute neutrophil count (ANC) greater than or equal to 1500/mm3 (greater than or equal to 1.5 X 103/uL) Absolute neutrophil count greater than or equal to 1,500/mcl Absolute neutrophil count (ANC) greater than or equal to 750/mm^3 ANC must be greater than or equal to 1500/mm3, Within 30 days prior to enrollment: Absolute neutrophil count greater than or equal to 1,500/mcl Absolute neutrophil count (ANC) greater than or equal to 1500/mm3 (greater than or equal to 1.5 X 103/ul) Granulocytes greater than or equal to 1500/ul Absolute neutrophil count (ANC) greater than or equal to 1500/µL Third or greater relapse. Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10 to the ninth/Liter Subject in whom all visible vessels or suture holes greater than or equal to 2mm in diameter have been ligated; Serum creatinine equal or greater than 2.5 mg/deciliter PART I: Greater than or equal to 1 week since standard or investigational treatment for metastatic disease REP ELIGIBILITY: Absolute neutrophil count greater than or equal to 1000/mcL CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Absolute neutrophil count greater than or equal to 1000/mcL Absolute neutrophil count greater than or equal to 1.5 x 10^9 cells/L Absolute neutrophil count greater than or equal to 1500/mm^3 Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^9/L (for Cohorts 3A and 3B leucocyte count greater than or equal to 2 x 10^9/L; participants with bone marrow involvement should have ANC greater than or equal to 0.8 x 10^9/L and leucocyte count greater than or equal to 1 x 10^9/L). Absolute neutrophil count (ANC) greater than or equal to 1000/mm^3 absolute neutrophil count (ANC) must be greater than or equal to 1000/mm3; ANC greater than or equal to 500 (7 days after last dose of growth factor) Absolute neutrophil count greater than or equal to 1000/mm^3 (Turnstile II) Serum creatinine less than or equal to 1.5 in males, or 1.4 in female Absolute neutrophil count greater than or equal to 1000/mm^3 (Turnstile II) Inclusion Criteria:\n\n Participants must meet all of the following criteria to be included in the study:\n\n 1. Age greater than or equal to 18 years.\n\n 2. Histopathologic diagnosis of CTCL (mycosis fungoides [MF] or Sezary Syndrome [SS]),\n confirmed by skin biopsy, or lymph node, or blood assessment, of current disease.\n\n 3. CD25 assay-positive tumor, defined as detectable CD25 on greater than or equal to 20%\n of total lymphoid infiltrate in biopsied skin lesions by immunohistochemistry.\n\n 4. CTCL disease stage at study entry as follows, according to ISCL/EORTC (Olsen 2011).\n\n - Lead-In Phase: Stage IA - IV, except participants with CNS involvement.\n\n - Main Study: Stage IA - IVA2 including lymph node disease N2 and N3\n\n 5. History of prior therapies for CTCL as follows: must have had prior therapy, any\n number of prior therapies allowed.\n\n Topical treatments (except topical chemotherapy) and steroids are not considered as\n prior therapies.\n\n 6. A minimum washout period of 4 weeks after previous CTCL therapy is recommended before\n the first dose of E7777.\n\n Participants must have recovered from any adverse effects from any previous CTCL\n therapy to CTCAE Grade <2 before starting study drug. A shorter washout may be allowed\n if participant is experiencing progressive disease despite ongoing treatment\n\n 7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 in the Lead-In\n Phase and performance status of 0 or 1 in the Main Study.\n\n 8. Life expectancy greater than or equal to 3 months in the Lead-In Phase and greater\n than or equal to 12 months in the Main Study.\n\n 9. Adequate bone marrow reserves as evidenced by:\n\n - platelets greater than or equal to 100,000/mm3 (100 x 10^9/L)\n\n - clinically stable hemoglobin greater than or equal to 9 g/dL (90 g/L) and\n hematocrit greater than or equal to 27% without transfusion support\n\n 10. Normal hepatic function as evidenced by:\n\n - bilirubin and alkaline phosphatase less than or equal to 1 x the upper limit of\n normal (ULN).\n\n - aspartate aminotransferase (AST) less than or equal to 75 U/L and alanine\n aminotransferase (ALT) less than or equal to 100 U/L.\n\n - albumin greater than or equal to 3.0 g/dL (30 g/L).\n\n 11. Adequate renal function as evidenced by serum creatinine less than or equal to 1.8\n mg/dL (158 umol/L) OR calculated creatinine clearance greater than or equal to 50\n mL/min (per the Cockcroft-Gault formula) with less than 2+ protein OR 24- hour urine\n creatinine clearance greater than or equal to 50 mL/minute with 24- hour urine protein\n less than 1g.\n\n 12. Provide written informed consent prior to any study-specific screening procedures.\n\n 13. Females may not be lactating or pregnant at Screening or Baseline\n\n 14. All females will be considered to be of childbearing potential unless they are\n postmenopausal or have been sterilized surgically\n\n 15. Male participants must have had a successful vasectomy (confirmed azoospermia) or they\n and their female partner must meet the criteria above\n\n Exclusion Criteria\n\n Participants who meet any of the following criteria will be excluded from the study:\n\n 1. Prior denileukin diftitox therapy\n\n 2. Use of topical steroids within 14 days of Day 1 of initial therapy is not allowed\n\n 3. Active malignancy (except for CTCL, definitively treated basal or squamous cell\n carcinoma of the skin, and carcinoma in-situ of the cervix) within the past 24 months.\n\n 4. Serious intercurrent illness\n\n 5. Significant cardiac disease requiring ongoing treatment, including congestive heart\n failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled\n cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI)\n\n 6. Significant pulmonary symptoms or disease\n\n 7. History of uncontrolled seizure disorder or active central nervous system disease\n\n 8. Major surgery within 2 weeks of study enrollment\n\n 9. Significant or uncontrolled infections requiring specific anti-infective therapy\n\n 10. Known human immunodeficiency virus (HIV) infection; known active hepatitis B or\n hepatitis C infection\n\n 11. Females who are pregnant (positive urine test) or breastfeeding\n\n 12. Any history of a medical condition or a concomitant medical condition that, in the\n opinion of the investigator, would compromise the participant's ability to safely\n complete the study. Absolute neutrophil count (ANC) greater than or equal to 750/mm^3 Creatinine less than or equal to 2.0 unless related to the disease ANC must be greater than or equal to 1500/mm3 Greater than or equal to 6 weeks since the receipt of chemotherapy or radiation therapy Bilirubin greater than or equal to 2.0 x ULN Inclusion Criteria\n\n 1. Signed written informed consent must be obtained and documented according to\n International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the\n local regulatory requirements, and permission to use private health information in\n accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior\n to study-specific screening procedures\n\n 2. For solid tumors or lymphoma, a histologically or cytologically confirmed solid tumor\n that is metastatic, unresectable, or recurrent and for which standard curative or\n palliative therapies do not exist or are no longer effective.\n\n 3. ? 18 years of age\n\n 4. For solid tumors, measurable disease as defined by Response Evaluation Criteria in\n Solid Tumors (RECIST 1.1)\n\n 5. For lymphoma, measurable disease as defined by the International Workshop to\n Standardize Response Criteria for Non-Hodgkin's Lymphoma\n\n 6. For multiple myeloma, measurable disease as defined by the International Uniform\n Response Criteria for Multiple Myeloma\n\n 7. Karnofsky performance status greater than or equal to 70%\n\n 8. Male or female patients of child-producing potential must agree to use contraception\n or avoidance of pregnancy measures during the study and for 30 days after the last\n BBI608 dose\n\n 9. Females of childbearing potential must have a negative serum pregnancy test\n\n 10. Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 1.5\n × upper limit of normal(ULN)\n\n 11. Hemoglobin (Hgb) greater than or equal to 10 g/dl\n\n 12. Total bilirubin less than or equal to 1.5 × ULN\n\n 13. Creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than 60\n mL/min/1.73 m2 for patients with creatinine levels above institutional normal.\n Creatinine < 2.5 x ULN for multiple myeloma patients.\n\n 14. Absolute neutrophil count greater than or equal to 1.5 x 109/L\n\n 15. Platelets greater than or equal to 100 x 109/L\n\n 16. Life expectancy greater than or equal to 3 months\n\n Exclusion Criteria\n\n 1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents\n within four weeks of first dose with the exception for a single dose radiation up to\n 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days\n before beginning the administration of BBI608.\n\n 2. Surgery within 4 weeks prior to first dose\n\n 3. Any known untreated brain metastases. Treated subjects must be stable for 4 weeks\n after completion of that treatment, with image documentation required. Patients must\n have no clinical symptoms from brain metastases and must be either off steroids or on\n a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients\n with known leptomeningeal metastases are excluded, even if treated.\n\n 4. Pregnant or breastfeeding\n\n 5. Significant gastrointestinal disorder(s), in the opinion of the Principal\n Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small\n intestine resection)\n\n 6. Unable or unwilling to swallow BBI608 capsules daily\n\n 7. Uncontrolled intercurrent illness including, but not limited to ongoing or active\n infection, clinically significant non-healing or healing wounds, symptomatic\n congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant\n pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled\n infection or psychiatric illness/social situations that would limit compliance with\n study requirements Inclusion Criteria\n\n 1. Signed written informed consent must be obtained and documented according to\n International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the\n local regulatory requirements, and permission to use private health information in\n accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior\n to study-specific screening procedures\n\n 2. For solid tumors or lymphoma, a histologically or cytologically confirmed solid tumor\n that is metastatic, unresectable, or recurrent and for which standard curative or\n palliative therapies do not exist or are no longer effective.\n\n 3. ? 18 years of age\n\n 4. For solid tumors, measurable disease as defined by Response Evaluation Criteria in\n Solid Tumors (RECIST 1.1)\n\n 5. For lymphoma, measurable disease as defined by the International Workshop to\n Standardize Response Criteria for Non-Hodgkin's Lymphoma\n\n 6. For multiple myeloma, measurable disease as defined by the International Uniform\n Response Criteria for Multiple Myeloma\n\n 7. Karnofsky performance status greater than or equal to 70%\n\n 8. Male or female patients of child-producing potential must agree to use contraception\n or avoidance of pregnancy measures during the study and for 30 days after the last\n BBI608 dose\n\n 9. Females of childbearing potential must have a negative serum pregnancy test\n\n 10. Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 1.5\n × upper limit of normal(ULN)\n\n 11. Hemoglobin (Hgb) greater than or equal to 10 g/dl\n\n 12. Total bilirubin less than or equal to 1.5 × ULN\n\n 13. Creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than 60\n mL/min/1.73 m2 for patients with creatinine levels above institutional normal.\n Creatinine < 2.5 x ULN for multiple myeloma patients.\n\n 14. Absolute neutrophil count greater than or equal to 1.5 x 109/L\n\n 15. Platelets greater than or equal to 100 x 109/L\n\n 16. Life expectancy greater than or equal to 3 months\n\n Exclusion Criteria\n\n 1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents\n within four weeks of first dose with the exception for a single dose radiation up to\n 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days\n before beginning the administration of BBI608.\n\n 2. Surgery within 4 weeks prior to first dose\n\n 3. Any known untreated brain metastases. Treated subjects must be stable for 4 weeks\n after completion of that treatment, with image documentation required. Patients must\n have no clinical symptoms from brain metastases and must be either off steroids or on\n a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients\n with known leptomeningeal metastases are excluded, even if treated.\n\n 4. Pregnant or breastfeeding\n\n 5. Significant gastrointestinal disorder(s), in the opinion of the Principal\n Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small\n intestine resection)\n\n 6. Unable or unwilling to swallow BBI608 capsules daily\n\n 7. Uncontrolled intercurrent illness including, but not limited to ongoing or active\n infection, clinically significant non-healing or healing wounds, symptomatic\n congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant\n pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled\n infection or psychiatric illness/social situations that would limit compliance with\n study requirements Absolute neutrophil count greater than or equal to 1000/mcL Granulocytes greater than or equal to 1500/ul ANC greater than or equal to 1,500 K/uL Biochemical recurrence: defined as a cancer antigen (CA)-125 greater than or equal to two times the upper normal limit; patients whose CA125 is less than 100 U/mL must undergo a second confirmatory value within a period of not more than 4 weeks; patients with a level greater than or equal to 100 U/mL may be entered without confirmatory measurement Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; Absolute neutrophil count (ANC) greater than or equal to 750/mm3 (greater than or equal to 0.75 X 10^9/L) Absolute neutrophil count greater than or equal to 1.5 x 109/L Inclusion Criteria:\n\n 1.18 years of age or older 2. Able to provide written informed consent or have their legal\n representatives provide written informed consent 3. Documented histological or cytological\n evidence of adenocarcinoma of the prostate. Subjects whose pathology reports are no longer\n available may be enrolled if, in the opinion of the investigator, the subject has a\n clinical course consistent with prostatic adenocarcinoma 4. ECOG Performance Status of 0 or\n 1 5. Undergone orchiectomy, or have ongoing LHRH analogue therapy prior to C1D1. Subjects\n on LHRH analogues should remain on these agents for the duration of the study 6. Castrate\n levels of testosterone less than or equal to 50 ng/dl (or 1.7 nmol/L) and have progressive\n disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values\n greater than or equal to 1 week between each assessment. The PSA value at the Screening\n visit must be greater than or equal 2ng/mL with or without: Soft tissue disease progression\n defined by RECIST 1.1 at Screening or less than or equal to 28 days of C1D1. Measurable\n disease is not required for entry.\n\n Lymph nodes greater than or equal to 1.5cm (short axis) are considered measurable disease\n bone disease progression defined by greater than or equal 2 new lesions on bone scan at\n Screening, or less than or equal 28 days of C1D1 7. Have received abiraterone and/or\n enzalutamide. Subject must have received either abiraterone or enzalutamide for greater\n than or equal to 12 weeks. Other second generation CYP17 inhibitors/androgen receptor\n antagonists including but not limited to TAK-700 (orteronel), TOK-001 (galeterone) may have\n been taken in place of abiraterone and ARN-509 (apalutamide) may have been taken in place\n of enzalutamide.\n\n 8. Adequate hematopoietic function as evidenced by:\n\n - WBC greater than or equal to 3,000/?l\n\n - ANC greater than or equal to 1,500/?l\n\n - Platelet count greater than or equal to 100,000/?l\n\n - HGB greater than or equal to 10 g/dl and not transfusion dependent 9. Adequate liver\n function, including all the following:\n\n - Total serum bilirubin less than or equal to 2.0 x ULN unless the subject has\n documented Gilbert syndrome;\n\n - Aspartate and alanine aminotransferase (AST & ALT) less than or equal to 3.0 x ULN or\n less than or equal to 5.0 x ULN if subject has liver metastasis;\n\n - Alkaline phosphatase less than or equal to 3.0 x ULN or less than or equal to 5 x ULN\n in case of bone metastasis and/or hepatic metastasis 10. Subjects must have adequate\n renal function as evidenced by a serum creatinine of less than or equal to 2.0 mg/dl\n 11. Potassium (K+) greater than or equal to 3.5 mEq/l 12. Subject and his female\n partner who is of childbearing potential must use 2 acceptable methods of birth\n control (one of which must include a condom as a barrier method of contraception)\n starting at Screening and continuing throughout the study period and for 3 months\n after final study drug administration.\n\n - Two acceptable forms of birth control include:\n\n 1. Condom (barrier method of contraception), and\n\n 2. One of the following:\n\n 1. Oral, injected or implanted hormonal contraception\n\n 2. Placement of an intrauterine device (IUD) or intrauterine system (ISU)\n\n 3. Additional barrier methods of contraception: Occlusive cap (diaphragm or\n cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.\n\n 4. Vasectomy or surgical castration greater than or equal to 6 months prior to\n Screening.\n\n 13. Able to swallow study medication 14. Able to comply with study requirements\n\n Exclusion Criteria\n\n Each subject eligible to participate in this study must not have any of the following:\n\n 1. Received sipuleucel-T (Provenge ®) treatment within 28 days of C1D1\n\n 2. Received 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or\n dutasteride (AVODART®) within 28 days of C1D1\n\n 3. Received any investigational agent less than or equal to 28 days of C1D1\n\n 4. Received palliative radiotherapy less than or equal to 2 weeks of C1D1\n\n 5. Symptomatic CNS metastases\n\n 6. History of another invasive malignancy less than or equal to 3 years of C1D1\n\n 7. A QTcF interval of greater than 470 msec; if the Screening ECG QTcF interval is\n greater than 470 msec, it may be repeated, and if repeat less than or equal to 470\n msec, the subject may be enrolled\n\n 8. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular\n fibrillation, torsades de pointes, second degree or third degree atrioventricular\n heart block without a permanent pacemaker in place)\n\n 9. Started a bone modifying agent (e.g. bisphosphonates, denosumab) less than or equal to\n 28 days of C1D1 (note: ongoing bone modifying agents administered less than 28 days\n are allowed)\n\n 10. Any medical condition that could preclude subject participation in the study, pose an\n undue medical hazard, or which could interfere with study results\n\n 11. Class III or IV Congestive Heart Failure (CHF) as defined by the New York Heart\n Association (NYHA) functional classification system within the previous 6 months\n\n 12. A history of loss of consciousness or transient ischemic attack less than or equal to\n 12 months of C1D1\n\n 13. Known active HIV, Hepatitis B, or Hepatitis C infections\n\n 14. Known or suspected hypersensitivity to seviteronel, or any components of the\n formulation\n\n 15. Any other condition which in the opinion of the investigator would preclude\n participation in the study Absolute neutrophil count (ANC) greater than or equal to 1.5 X 10^9/L Patients must have an interval of greater than or equal to 60 days from the completion of radiation therapy to study entry Patients must have adequate: i. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl. ii. Renal function: Creatinine ? 1.5 x institutional upper limit normal (ULN). iii. Hepatic function: Bilirubin ? 1.5 x ULN. SGOT (AST) and SGPT (ALT) ? 3.0 x ULN and alkaline phosphatase ? 2.5 x ULN. iv. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL. DLCO less than or equal to 65% or FEV1 less than or equal to 65%; Baseline LVEF greater than or equal to (>/=) 55% At the time of study entry, blood counts performed within 4 weeks prior to study entry must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1000/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 9 g/dL CTCAE v4.0 greater than or equal to grade 2 vomiting related to metastatic disease. Greater than or equal to 10 mm of cervical stromal invasion Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L (greater than or equal to 1500/mm^3) Adequate organ function, defined as follows: 8.1. Electrocardiogram (ECG) without significant anomalies, performed in the 7 days preceding entry 8.2. Haemoglobin greater than or equal to 90 g/L 8.3. Total white blood cell count (WBC) greater than or equal to 3.0 x 10^9/L 8.4. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L 8.5. Platelet count greater than 100 x 10^9/L 8.6. Total bilirubin less than or equal to 1.5 fold the maximum normal value at the place of evaluation or 2.5 fold the maximum normal value in case of liver metastases 8.7. Glutamic-oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), and glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), less than or equal to 2.5 fold the maximum normal value at the place of evaluation (in case of liver metastasis, less than 5 fold the maximum normal value) 8.8. Creatinine less than or equal to 2 mg/dL (less than or equal to 176 µmol/L) A discrete hepatic artery feeding the tumor with diameter of the vessels equal to or greater than 1.5 mm. Evidence of myeloid engraftment defined by absolute neutrophil count greater than or equal to (>=) 0.5*109/liter (L) on 3 consecutive days. Absolute neutrophil count greater than or equal to 1000/mcl For Post-allo Part B: Transplant must have been performed with active AML (greater than 5% blasts) using a conventional conditioning regimen and have achieved CR or CRi post-alloSCT (with ANC greater than or equal to 1,000 and platelet greater than or equal to 50,000) Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3 Grade greater than equal to (>=) 3 hypertriglyceridemia Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients A minimum of any one of the following disease-related symptoms must be present: a. Unintentional weight loss greater than or equal to 10% within the previous six months; b. Fevers greater than 100.5°F (38.0°C) for greater than or equal to 2 Weeks without evidence of infection; Or c. Night sweats for more than 1 month without evidence of infection. History of hemoptysis greater than or equal to (>/=) grade 2 within 3 months of randomization Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3 or greater than or equal to 1.5 x 10^9/L. Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until 5 days after the erythrocyte transfusion. Serum bicarbonate greater than or equal to 20 mEq/L Low lean mass defined as either\r\n* Age- and sex- specific relative lean muscle mass standard deviation scores =< -1.0 OR\r\n* Body fat content greater than or equal to 25% in males or greater than or equal to 35% in females Greater or equal to 6 months from last chemotherapy treatment Greater than or equal to grade 2 dry mouth prior to chemoradiotherapy or greater than or equal to grade 2 mucositis Adequate serum folate (greater than or equal to 2 ng/mL) and vitamin B12 (greater than or equal to 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening. Patient has grade 2 or greater hypo-albuminemia, serum sodium greater than 150 meq/L, serum osmolality greater than 300 mOsm/kg or blood urea nitrate/serum creatinine ratio greater than 25, within 7 days of screening Mini Mental State Exam score greater than or equal to 19 Requiring greater than or equal to 180 mg of morphine per day African-American postmenopausal women with waist circumference greater than 35 inches (88 cm), 5-year invasive breast cancer risk is greater than 1.40% using the Contraceptive and Reproductive Experience (CARE) model, and have at least one of the following:\r\n* Elevated fasting glucose is greater than or equal to 100 mg/dL\r\n* Elevated blood pressure is greater than or equal to 130/85 mm/Hg Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2 Patients with an existing local or systemic infection as defined by evidence of fever (a body temperature greater than or equal to 38.0° Celsius (C) with two readings taken at least 10 minutes apart or one body temperature greater than or equal to 38.3°) and any of the following within 24 hours of enrollment: (a) pulse rate greater than or equal to 100 beats/min; (b) respiratory rate greater than or equal to 20/min; (c) white blood cell (WBC) count greater than or equal to 12,000/mm, less than or equal to 4,000/mm or differential count showing greater than 10% band forms; (d) systolic blood pressure less than or equal to 90 mm Hg T1 post contrast lesion size greater than or equal to 10 mm Life expectancy (in the opinion of the investigator) of greater than or equal to (>=) 12 weeks and LDH levels less than or equal to (<=) 2.5 ULN Absolute neutrophil count (ANC) greater than or equal to (>=) 1500 per cubic millimeter (/mm^3). The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (?L), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/?L. The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (?L), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/?L.