International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): International normalized ratio (INR) =< 3 (to be done/tested only for subjects on warfarin) Patients receiving anticoagulation treatment are allowed to participate with international normalized ratio (INR) established within the therapeutic range International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 Obtained within 14 days prior to treatment start: International normalized ratio (INR) =< 1.5 Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5 International normalized ratio (INR) < 1.1 x institutional upper limit of normal International normalized ratio (INR) =< 1.2 X upper limit of normal (ULN) International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.2 International normalized ratio of < 1.5 International normalized ratio (INR)/PTT =< 2 times normal; timeline: within 3 weeks prior to enrollment Blood coagulation parameters: international normalized ration (INR) =< 1.5 International normalized ratio (INR) ? 1.5 × ULN (? 2.5 × ULN if on anticoagulants) International normalized ratio (INR) =< 1.5 Adequate coagulation tests: international normalized ratio ?1.5 Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5 International normalized ratio (INR) = 1.7 International normalized ratio (INR) =< 1.5 unless on direct thrombin inhibitor at time of study entry International normalized ratio (INR) =< 2 Coagulation: International normalized ratio (INR) ?1.2 within 28 days of starting study. International normalized ratio (INR) ?1.5; Adequate blood coagulation function defined by International Normalized Ratio (INR) ?1.5 (except for participants on warfarin therapy where INR must be ?3.0 prior to randomization) International normalized ratio (INR) =< 1.5 Obtained =< 2 weeks prior to registration: International normalized ratio (INR) =< 1.5 ULN International normalized ratio =< 1.5 International normalized ratio (INR) =< 1.5 International Normalized Ratio (INR) for coagulation above upper normal range International normalized ratio (INR) ? 2 × ULN International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 International Normalized Ratio (INR) < 1.5 (except if patient is on oral anticoagulation therapy). Must have an international normalized ratio (INR) < 1.5 International normalized ratio (INR) =< 1.5 International Normalized Ratio (INR) > 1.5 Normal coagulation defined as normal International Normalized Ratio (INR) or per institutional guidelines. International normalized ratio (INR) < 1.5. International normalized ratio (INR) =< 1.7 International normalized ratio (INR) < 2.0. International normalized ratio (INR) less than 1. 5 X ULN International normalized ratio (INR) < 1.5. International normalized ratio (INR) < 1.3 International normalized ratio (INR) < 1.3 International normalized ratio > 1.5 Patients who have an international normalized ratio (INR) or platelet count which are not correctable to < 1.8 and > 35,000 respectively Obtained with 21 days of registration: international normalized ratio =< 2.3 International normalized ratio (INR) =< 1.5 X institutional upper limit of normal (ULN) for patients not receiving therapeutic anticoagulation (unless dysfunction is secondary to lymphoma involvement) International normalized ratio (INR) from 0.8 to 1.2 Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) ?1.5 International normalized ratio (INR) =< 1.5 (except for patients who are on full-dose warfarin) International normalized ratio (INR) < 1.5 (For both cohorts A and B): International normalized ratio (INR) =< 2 International normalized ratio (INR) =< 1.5 obtained < 4 weeks prior to starting treatment International normalized ratio (INR) =< 1.5 International Normalized Ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 x ULN International normalized ratio (INR) =< 1.5 x ULN International normalized ratio (INR) =< 1.5 International normalized ration (INR) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed International normalized ratio (INR) =< 1.7 Obtained within 14 days prior to registration; international normalized ratio (INR) ? 2 Completed within 60 days of surgery: International normalized ratio INR ? 1.5 in patients not utilizing systemic anticoagulation as part of their medical regimen International normalized ratio (INR) =< 2.0 or correctable to 2.0 with vitamin K therapy International normalized ratio (INR) > 1.5 INR International normalized ratio (INR) =< 1.2 International normalized ratio (INR) < 1.5 x ULN International normalized ratio (INR) >= 1.7 Obtained =< 14 days prior to registration: International normalized ratio (INR) =< 2.0 International normalized ratio (INR) < 1.5 International normalized ratio (INR) < 1.5 International normalized ratio (INR) =< 2 Therapeutic anticoagulation with international normalized ratio (INR) modifying drug of or use of antiplatelet therapy (with the exception of low dose aspirin < 325mg/d) International normalized ratio (INR) =< 1.5 unless on warfarin in which case INR < 3.0 is acceptable International normalized ration (INR) =< 1.5 The patient must have adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and International normalized ratio (INR) =< 2 International normalized ratio (INR) =< 2.0 International normalized ratio (INR) =< 1.5 x institutional ULN International normalized ratio (INR) is =< 1.5 International normalized ratio (INR) =< 2 International normalized ratio (INR) =< 2 International normalized ratio (INR) from 0.8 to 1.2 Coagulopathy international normalized ratio (INR) > 1.5 Known, existing uncontrolled coagulopathy, international normalized ratio (INR) > 1.5 International normalized ratio (INR) =< 1.5 Known coagulopathy/thrombocytopenia (international normalized ratio [INR] > 1.5, platelets < 75) International normalized ratio (INR) < 2.0 International normalized ratio or INR must be =< 1.5 unless on therapeutic blood thinners International normalized ratio (INR) < 1.3 “International normalized ratio” or INR must be =< 1.5 International normalized ratio (INR) =< 1.8 International normalized ratio (INR) =< 2 International normalized ratio (INR) < 1.3 x ULN International normalized ratio (INR) value greater than 1.5 International normalized ratio (INR) =< 2 International normalized ratio (INR) < 2.0 International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 International normalized ratio (INR) < 2 International normalized ratio or INR must be =< 1.5 unless on therapeutic blood thinners International normalized ratio (INR) < 2; subjects on anticoagulant (such as coumadin) must have an international normalized ratio (INR) < 5 International normalized ratio (INR) < 2.0 International normalized ratio (INR) must be =< 2.3 International normalized ratio (INR) =< 1.7 International normalized ratio (INR) < 1.3 (or < 3 if on warfarin or other anticoagulants) during screening evaluation International normalized ratio (INR) > 2.0 International normalized ratio (INR) =< 2 International normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) International normalized ration (INR) < 1.5 International normalized ratio (INR) ? 2 (If coagulopathy is related to disease, this criterion does not apply) within 14 days prior to registration International normalized ratio (INR) =< 1.5 =< 14 days prior to registration International normalized ratio or INR must be ? 1.5 unless on therapeutic blood thinners ? 2 weeks International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.4 Within 14 days prior to registration: International normalized ratio (INR) < 2.0 Performed within 14 days prior to study: International normalized ratio (INR) < 2 if off of anticoagulation; patients on anticoagulation therapy with an INR > 2 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage International normalized ratio (INR) =< 1.5 ARM A: obtained =< 14 days prior to registration: \r\n* International normalized ratio (INR) =< 1.5 x ULN International normalized ratio (INR) =< 1.4 unless receiving therapeutic doses of coumadin International normalized ratio (INR) =< 2 International normalization ratio (INR) =< 2.0 mg/dL International normalized ratio (INR) =< 1.5 International normalized ratio (INR) < 1.3 (or < 3 if on warfarin or other anticoagulants) International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 Within 14 days of subject registration: International normalized ratio (INR) =< 1.5 International normalized ratio =< 1.3 (or =< 3 on anticoagulants) International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.2 International normalized ratio (INR) =< 1.5 X ULN (if not on anticoagulation) International normalized ratio (INR) < 1.5 (or < 3 if on warfarin or other anticoagulants) International normalized ratio (INR) =< 1.5 International normalized ratio or INR must be < 1.5 International normalized ratio (INR) =< 1.5 x ULN International normalized ratio (INR) =< 2 International normalized ratio (INR) =< 1.5 x institutional ULN International normalized ratio (INR) =< 2.0 Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (INR) laboratory values cannot be > 1.5 x upper limit of normal at study entry. International normalized ratio (INR) =< 1.5 Performed within 14 days of patient registration: International normalized ration (INR) =< 1.5 Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) ? 1.5. Coagulation: International Normalized Ratio (INR) ? 1.2 International normalized ratio (INR) =< 2, obtained =< 21 days prior to registration Coagulation: International Normalized Ratio (INR) ? 1.2 Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5. International normalized ratio (INR) =< 1.5 International normalized ratio (INR) > 2 International normalized ratio (INR) > 1.5 International normalized ratio (INR) within normal limits (UIHC) Adequate blood coagulation function, defined as international normalized ratio (INR) less than or equal to 2.3 International normalized ratio (INR) < 1.5 x institutional ULN International normalized ratio (INR) must be < 1.5 International normalized ratio (INR) =< 1.4 x ULN International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 2; factor 10A drawn if patient on anticoagulant Eliquis International normalized ratio (INR) > 2 in the absence of anticoagulation therapy International normalized ratio (INR) =< 1.5 x ULN International normalized ratio (INR) =< 1.5. International normalized ratio (INR) > 2 International normalized ratio (INR) =< 1.5 International normalized ratio > 1.7 International normalized ratio (INR) < 1.5 times ULN International normalized ratio (INR) < 2.0 International normalized ratio (INR) < 1.5 x ULN for institution unless patient is on planned therapy with anticoagulants (i.e., warfarin) with higher target planned obtained =< 14 days prior to registration; in those cases, INR up to 3.5 is acceptable International normalized ratio (INR) =< 1.5 international normalized ratio (INR) must be within normal limits of the local laboratory ranges. International normalized ratio (INR) =< 2 International normalized ratio (INR) < 2 International normalized ratio (INR) =< 2 International normalized ratio (INR) less than or equal to 2 Adequate blood clotting time with an international normalized ratio (INR) < 2 International normalized ratio (INR) =< 2.0 International normalized ratio (INR) > 2 International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial cryoablation procedure. International normalized ratio (INR) must be less than 1.5 in patients not on Coumadin therapy Patients receiving anticoagulation treatment are allowed to participate with international normalized ratio (INR) established within the therapeutic range International normalized ratio (INR) < 1.3 (or < 3 on anticoagulants) International normalized ratio (INR) must be =< 1.5 unless on therapeutic blood thinners International normalized ratio (INR) =< 2.0 (unless due to therapeutic warfarin use) International normalized ratio or INR must be =< 1.5 unless on therapeutic blood thinners International normalized ratio (INR) =< 1.5 International normalized ratio (INR) < 1.5 x ULN International normalized ratio (INR) =< 2.5 Obtained within 2 weeks from study entry: International normalized ratio (INR) =< 2 International normalized ratio (INR) >= 1.5 International normalized ratio (INR) =< 1.5 unless using warfarin for therapeutic anti-coagulation International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.4 International normalized ratio (INR) > 1.5; (in patients receiving anticoagulants [such as warfarin] INR must be between 2.0 and 3.0 in two consecutive measurements 1-4 days apart) Elevated international normalized ratio (INR) (> 1.7) International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 x ULN International normalized ratio (INR) =< 1.5 (anticoagulation is allowed if target INR =< 1.5 on a stable dose for > 2 weeks at time of study entry) International normalized ratio (INR) =< 2 International normalized ratio (INR) =< 1.7 (if not due to anticoagulants) International normalized ratio (INR) =< 1.4 x ULN at the time of registration Platelet count <50,000/mm3 or international normalized ratio >1.5. International Normalized Ratio of at least 1.7 Adequate hepatic function including: International normalized ratio (INR) =< 2 International normalized ratio (INR) =< 2 International normalized ratio (INR) ? 1.5 x ULN International normalized ratio (INR) ? 1.5 x ULN International normalized ratio (INR) < 1.5 “International normalized ratio” or INR must be =< 1.5 Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 International normalized ratio (INR) =< 1.5 For patients not receiving anticoagulation: international normalized ratio of a measure of prothrombin time (international normalized ratio [INR]) =< 1.3 International Normalized Ratio (INR) < 1.5 and aPTT within 1.1 x ULN International normalized ratio (INR) < 1.5 International normalized ratio (INR) >1.5x ULN International normalized ratio (INR) greater than 1.3 International Normalized Ratio (INR) ?1.7 Vitamin K antagonist therapy and an international normalized ratio >1.3 on the day of surgery. An abnormal INR (international normalized ratio of greater than 1.3), if repeatable and refractory to correction by routine methods International normalized ratio (INR) >= 1.5 Coagulation: International Normalized Ratio (INR) ? 1.2 International normalized ratio (INR) 1.5, platelets < 75 K) International normalized ratio (INR) < 1.5 × ULN International normalized ratio (INR) > 2.5 and/or International normalized ratio (INR) less than or equal to (?) 1.6 (unless receiving anticoagulation therapy) International normalized ratio (INR) =< 2 International normalized ratio (INR) < 1.3 (or ? 3.0 if on therapeutic anticoagulation) International normalized ratio (INR) < 1.3 (or < 3 on anticoagulants) International normalized ratio (INR) =< 1.5 x ULN; patients receiving anti-coagulation therapy are permitted as long as they have a stable INR =< 3.0 International normalized ratio (INR) =< 1.5 or International normalized ratio (INR) =< 1.2 X upper limit of normal (ULN) International normalized ratio (INR) =< 1.3 (or =< 3 on anticoagulants) International normalized ratio (INR) < 1.5 International normalized ratio (INR) =< 2.0 International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 International normalized ratio (INR) > 2 Within 30 days of surgery: International normalized ratio (INR) =< 1.5 Patients with history of severe liver disease, defined as and confirmed by international normalized ratio (INR) 1.5 or greater per institutional laboratory. International normalized ratio (INR) < 1.3 (or < 3 if on anticoagulant therapy). International normalized ratio (INR) =< 1.5 (corrected if needed) Currently on warfarin with an international normalized ratio (INR) > 1.4 or clopidogrel that cannot be discontinued 7 days prior to surgery International normalized ratio (INR) > 1.5 International normalized ratio (INR) =< 1.8 times institutional upper limit of normal Abnormal coagulation parameters (international normalized ratio [INR] > 1.5 not on Coumadin, or platelet count < 100,000) Coagulopathy (international normalized ratio [INR] > 2, platelets < 50,000) Obtained =< 30 days prior to randomization: International normalized ratio (INR) =< 1.6 (if not taking anticoagulant therapy) International normalized ratio (INR) =< 1.5 Patients with international normalized ratio (INR) > 1.5 International normalized ratio (INR) =< 2 Minocycline trial only: patients who are under treatment of warfarin with international normalized ratio (INR) > 1.5 INR (International Normalized Ratio) <1.5 within 6 weeks screening International normalized ratio (INR) =< 1.5 (within 30 days of surgery) International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 2 International normalized ratio (INR) =< 2 International normalized ratio (INR) =< 1.5 x ULN International normalized ratio (INR) =< 1.3 International normalized ratio (INR) < 1.5 \r\n* For patients on Coumadin general clinical guidelines for interventional radiology (IR) ablation will be followed Coagulopathy with international normalized ratio (INR) > 2.0 or Severe coagulopathy (international normalized ratio [INR] > 1.8) or Adequate blood coagulation as evidenced by an International Normalized Ratio (INR) ?1.5. Low-density lipoprotein (LDL) question for lung surgery do we need an international normalized ratio (INR) < 1.6 International normalized ratio (INR) < 1.3 (or < 3 if on warfarin or other anticoagulants) at the screening visit International Normalized Ratio (INR) < 1.5 (except if patient is on oral anticoagulation therapy). International Normalized Ratio (INR) >1.5 x ULN Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) ?1.5. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose), within 2 weeks of randomization International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (or on stable dose of therapeutic anticoagulation, such as low-molecular-weight heparin, warfarin or rivaroxaban) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) Partial thromboplastin time (PTT) / prothrombin time (PT) =< 1.5 x ULN or international normalized ratio (INR) < 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose. Obtained =< 21 days prior to registration: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN; NOTE: This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) International normalized ratio (INR) and partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose. STUDY TREATMENT: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 × ULN within 14 days prior to the first study treatment.\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose. International normal ratio (INR) < 1.3 or ? institutional ULN (or ? 3.0 if on therapeutic anticoagulation) International normalized ratio (INR) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) Activated partial thromboplastin time (aPPT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN.\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN if not on therapeutic anticoagulation; patients receiving therapeutic anticoagulation will be allowed if maintained on a stable dose within 14 days of study registration International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN; this applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose International normalized ratio (INR) and activated partial thromboplastin time (aPTT) > 1.5 x upper limit of normal (ULN) \r\n* This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose Within 14 days prior to cycle 1 day 1 of treatment: International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin Time (aPTT) =< 1.5 x ULN (Note: This applies only to subjects who are not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose) Within 14 days prior to the first study treatment (cycle 1, day 1): International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ? 1.5 X ULN; this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN; this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ? 1.5 × ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation [such as low-molecular-weight heparin or warfarin] should be on a stable dose.) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low?molecular weight heparin or warfarin) should be on a stable dose INR and aPTT ? 1.5 x ULN • This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose. Within 14 days of enrollment: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN if not on therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose International normalized ratio (INR) and activated partial thromboplastin time aPTT =< 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN; this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular weight heparin or warfarin) should be on a stable dose International normalized ratio (INR) and partial thromboplastin time (aPTT) ? 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose International normalized ratio (INR) > 1.5 and activated partial thromboplastin time (aPTT) > 1.5 x the ULN (except for subjects receiving anticoagulation therapy) in the absence of therapeutic intent to anticoagulate the subject; therapeutic anticoagulation is permitted International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low molecular weight heparin or warfarin) should be on a stable dose. Institutional normalized ratio (INR) =< 1.5 x ULN (this applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose) Activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose) International normalized ratio (INR) < 1.5, unless patient is on therapeutic anticoagulation where a therapeutic INR is acceptable; anticoagulation with low molecular weight heparin or warfarin, where medically indicated, is permitted* Coagulation: International Normalized Ratio (INR) < 1.5 times normal, activated Partial Thromboplastin Time (aPTT) < 1.5 times normal. Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible for the trial if INR and aPTT are within the acceptable therapeutic limits for the institution. Prothrombin time, international normalized ratio (INR), and/or activated partial thromboplastin time within =< 1.5 x ULN (for treatment phase) Any of the following abnormal laboratory values (unless due to underlying lymphoma): International normalized ratio (INR) or prothrombin time (PT) >1.5*upper limit of normal (ULN) in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) >1.5*ULN in the absence of a lupus anticoagulant Patients must have adequate coagulation function as evidenced by prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) within normal institutional limits Has adequate blood clotting function, defined as: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN. Prothrombin time (PT) such that the international normalized ratio (INR) is < 1.5 x ULN and activated partial thromboplastin time (aPTT) < 1.5 x ULN; prophylactic heparin or low molecular weight heparin (enoxaparin or alternative anticoagulants [other than warfarin]) are acceptable Obtained within 28 days prior to registration: International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 INCLUSION - PROCUREMENT: If pheresis required to collect blood\r\n* Prothrombin time (PT) and activated partial thromboplastin time (APTT) <1.5 × upper limit normal For patients with planned deep tumor injections: prothrombin time (PT), activated partial thromboplastin time (aPPT), and international normalized ratio (INR) within normal limits; Platelet count ?100,000/?L; hemoglobin ? 9 gm/dL. For participants not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to ( 1.5 times ULN, or\r\n* Activated partial thromboplastin time (aPTT) > 1.5 times ULN Adequate hemostatic function as determined by prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 x ULN (unless on therapeutic coagulation, in which case the adequate level of anticoagulation will be determined by the investigator) Prothrombin time (PT)/activated partial thromboplastin time (aPTT) within normal limits at time of surgery Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN Total bilirubin =< 1.5 X institutional limits; subjects with Gilbert's syndrome may have a bilirubin > 1.5 x upper limit of normal (ULN); activated partial thromboplastin time (aPTT), prothrombin time (PT) not to exceed 1.2 x ULN Within 14 days prior to registration: International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) as follows:\r\n* In the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x upper normal limit (ULN) or aPTT < 1.5 x ULN\r\n* In the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registration UROTHELIAL CARCINOMA EXPANSION COHORT: Prothrombin (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) within 1.25 X ULN institutional limits, except where a lupus anti-coagulant has been confirmed International normalized ratio (INR) =< 1.5 or prothrombin time (PT) =< 1.5 ULN, and a partial thromboplastin time (PTT/activated partial thromboplastin time [aPTT]) =< 1.5 x ULN International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN; patients on anticoagulation are expected to hold anticoagulation for at least 5 days prior to surgery Performed within 14 days (+3 working days) of treatment initiation: Coagulation international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.5 X ULN Normal coagulation parameters (elevated international normalized ratio (INR), prothrombin time or activated partial thromboplastin time (APTT) ?1.3 ULN range acceptable). Subjects must have adequate blood clotting function, defined as international normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN International Normalized Ratio (INR) > 1.5 ULN or activated partial thromboplastin time (aPTT) > 1.5 ULN. Subject is currently receiving or intending to receive anti-coagulants for therapeutic purposes. Prophylactic use of anticoagulants is allowed. Normal coagulation parameters (prothrombin time [PT], activated partial thromboplastin time [aPTT]) Prothrombin time (PT) (or international normalized ratio [INR]) and partial thromboplastin time (PTT) (or activated partial thromboplastin time [aPTT]) > 1.5 x ULN International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (for patients on anticoagulation they must be receiving a stable dose for at least 1 week prior to randomization) Has adequate blood clotting function, defined as: - International normalized ratio and activated partial thromboplastin time =<1.5 XULN Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (aPTT) above the normal range (low dose deep vein thrombosis (DVT) or line prophylaxis is allowed). Prothrombin time (PT)/international normalized ratio (INR)/ activated partial thromboplastin time (aPTT) =< 1.5 x ULN (to be performed within 7 days prior to start of study treatment) International normalized ratio =< 1.5 and activated prothrombin time =< 1.5 x ULN within 7 days prior to enrollment; the use of full-dose oral or parenteral anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least two weeks prior to the first study treatment Abnormal coagulation parameter (prothrombin time [PT] or activated partial thromboplastin time [aPTT] > 1.3x longer than standard reference) Patients must have adequate coagulation (international normalized ratio [INR] ? 1.5, activated partial thromboplastin time [aPTT] ?1.5 X the upper limit of normal [ULN]) Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) All screening labs should be performed within 14 days (+3 working days) of treatment initiation: international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.5 x ULN. International normalized ratio (INR) within 1.5 times ULN (or if receiving anticoagulant therapy an INR of =< 3.0 is allowed with concomitant increase in prothrombin time (PT) or an activated partial thromboplastin time (aPTT) =< 2.5 x control) Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.2 times upper limit of normal International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN Activated partial thromboplastin time (aPTT), prothrombin time (PT) =< 1.2 x upper limit of normal (ULN) Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< upper limit of normal (ULN) for age Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.3 x ULN Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) must be < 1.5 x the upper limit of the normal range (ULN); except if, in the opinion of the investigator, the aPTT is elevated because of a positive lupus anticoagulant Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.2 x upper limit of normal (ULN) International normalized ratio (INR) =< 1.5 and activated partial thromboplastin time (aPTT) within 1.1 x ULN; patients on warfarin therapy are not eligible due to the requirement for multiple biopsies Prothrombin time (PT) and activated partial thromboplastin time (APTT) =< 1.5 times upper limit of normal International normalized ratio (INR), activated partial thromboplastin (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening) Baseline laboratory data as defined as: Hemoglobin (Hb): >=8g/dL Absolute Neutrophil Count (ANC): >=1000/µL Platelet (PLT): >=25000/µL Glomerular Filtration Rate (GFR) or Creatinine Clearance: >=30ml/min Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): <3 x Upper Limit of Normal (ULN) Bilirubin - total: <1.5 x ULN Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) or International Normalized Ratio (INR): <=1.5 x ULN PT <=1.5 x ULN, INR <=1.5 Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN For patients not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) =< 1.5 x ULN, obtained within 14 days prior to initiation of study treatment Individuals not receiving anticoagulant medication must have an international normalized ratio (INR) ? 1.5 and activated partial thromboplastin (aPTT) ? 1.5 x upper limit of normal (ULN) Prothrombin time (PT) or prolongation of the activated thromboplastin time (aPTT) >1.5 ULN or active uncontrolled coagulopathy or bleeding disorder. Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN International normalized ratio (INR) and activated partial thromboplastin time (aPTT) > 1.5 x ULN, in subject who is not therapeutically anticoagulated. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN for the lab International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless on medication known to alter INR and/or aPTT International normalized ratio (INR) ? 1.5 and activated partial thromboplastin time (aPTT) ? 1.5 x the ULN. Prothrombin time (PT)/ international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limit of normal Within 14 days prior to registration: coagulation parameters (international normalized ratio [INR], activated partial thromboplastin time [aPTT]) =< 1.25 x institutional ULN Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x institutional upper limit of normal, within 14 days of study registration International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (APTT) as follows: in the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x ULN or aPTT < 1.5 x ULN; in the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registration (within 7 days prior to registration) Coagulation parameters (international normalized ratio [INR], activated partial thromboplastin time [aPTT]) =< 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN; if on active anticoagulants prior to study treatment, levels must be within standard therapeutic ranges per investigator Adequate coagulation parameters, defined as International Normalisation Ratio <1.5 x ULN or activated partial thromboplastin time <1.5 x ULN. Prothrombin time (PT)/international normalized ratio (INR) < 1.5 ULN and partial thromboplastin time (PTT) activated partial thromboplastin time (aPTT) < 1.5 X ULN; if value is higher due to hepatic involvement by CLL, patient is eligible At least 4 weeks (28 days) prior to registration: Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (unless on medication known to alter INR and aPTT) International normalized ratio (INR), activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) > 1.5 × ULN (unless on anticoagulation medication) Coagulopathy (as evidence by prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times upper limit of normal in patients not undergoing anticoagulation) Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) < 1.5 x ULN Absence of active treatment with systemic anticoagulation and a baseline prothrombin time (PT) and activated partial thromboplastin time (aPTT) that does not exceed 1.5 x ULN Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.2 x institution’s ULN International normalized ratio (INR) =< 1.5 and activated partial thromboplastin time (aPTT) within normal limits (WNL) Prothrombin time (PT) or international normalized ratio (INR), and activated partial thromboplastin time (APTT) =< 1.5 x upper limit of normal (ULN), unless the abnormality can be explained by the presence of lupus anticoagulant or if these values are in the therapeutic range for a patient on low molecular weight heparin Activated prothrombin time (APTT) =< 1.5 x ULN For patients undergoing biopsy procedures: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be within the normal range International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless on medication known to alter INR and aPTT Prothrombin time (PT)/international normalized ratio (INR) > 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) > 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder) Coagulation parameters (international normalized ratio [INR], activated partial thromboplastin time [aPTT]) within 1.25 x upper limit of normal institutional limits, except where a Lupus anti-coagulant has been confirmed International normalized ratio (INR), activated partial thromboplastin time (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening) Prothrombin time (PT) and activated partial thromboplastin time (aPTT) <1.5 times the upper limit of normal (ULN) Coagulopathy (as evidenced by prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times in control patients not undergoing anticoagulation) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* Unless the patient is on therapeutic anticoagulation Serum creatinine >ULN, or Prothrombin time (PT) or international normalized ratio (INR) >1.5 × ULN or activated partial thromboplastin time (aPTT) > 1.5 × ULN Activated partial thromboplastin time (aPTT) ? 1.25 ULN and international normalized ratio (INR) ? 1.3 (unless the subject is receiving therapeutic anticoagulants); Activated partial thromboplastin time (APTT) must not exceed 32.5 seconds (normal range 21.8-31.5 seconds); international normalized ratio (INR) must not exceed 1.30 (normal range 0.87-1.18) Patients with known bleeding diathesis, or PT (Prothrombin time) or aPTT (activated partial thromboplastin time) > 1.5x ULN or <0.5x LLN. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) <=1.5*ULN Has adequate blood clotting function, defined as: International normalized ratio and activated partial thromboplastin time <= 1.5 X ULN Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limit of normal (ULN) for age International normalized ratio (INR) and activated partial thromboplastin time (aPTT) 1.4 and activated partial thromboplastin time (aPTT) > 3 seconds above the upper limit of normal for age, within 1 week prior to enrollment. Screening laboratory values (serum chemistry, hematology, prothrombin time [PT](international normalized ratio [INR])/activated partial thromboplastin time [APTT], and creatine phosphokinase [CPK]) obtained up to 28 days prior to administration of first vaccine injection on day 0 within institutional normal range or judged to be not clinically significant by principal investigator (PI) and medical monitor Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) =< 1.5 x upper limit of normal International normalized ratio (INR) and activated thromboplastin time within normal institutional limits Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 x upper limit of normal (ULN), completed within 2 weeks prior to start of protocol therapy Subjects taking warfarin should be monitored regularly for changes in prothrombin time or international normalized ratio (INR) International normalized ratio of prothrombin time (INR) and prothrombin time (PT) must be =< 1.5 x ULN for the lab within 28 days before randomization; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history Prothrombin time (PT)-international normalized ratio (INR) =< 1.5 x institutional ULN (for participants on anticoagulation therapy, =< 1.5 x their baseline value) Prothrombin time (PT)-international normalized ratio (INR) =< 1.5 x institutional ULN (for participants on anticoagulation therapy, =< 1.5 x their baseline value) International normalized ratio (INR) or prothrombin time (PT) INR ?1.5 × institutional ULN or PT ?5 seconds above institutional ULN Prothrombin time (PT)/international normalized ratio and (PTT) in normal range ± 25% International normalized ratio/prothrombin time ? 1.5 x upper limit or normal Prothrombin time (PT) or international normalize rate (INR) within 1.5x upper limit of normal; Prothrombin time international normalized ratio (INR) =< 2 Prothrombin (PT) - international normalized ratio (INR) < 1.5 Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 X ULN, obtained =< 14 days prior to registration Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x institutional upper limit of normal (or an in-range INR, usually between 2 and 3 if a patient is on a stable dose of therapeutic warfarin) International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN Prothrombin time (PT) within 2 seconds of the upper limit of normal (institutional normal ratio [INR] =< 1.8) International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN PT (Prothrombin time) and/or international normalized ratio (INR) =< 1.5 x ULN International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin) (obtained within 28 days prior to first study treatment) Prothrombin time or international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) Obtained =< 14 days prior to registration: Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 X ULN Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 Prothrombin time/international normalized ratio (PT INR) < 1.4 Prothrombin time (PT) and international normalized ratio (INR) =< 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) =< 2.3 or PT =< 6 seconds above control (within 14 days prior to registration)\r\n* NOTE: Abnormal PT/INR may be considered, with documented principal investigator (PI) approval, if it is due to the use of anticoagulants; for such patients, a normal PT/INR must be available from before the start of anticoagulation treatment\r\n* NOTE: Performed at time of screening angiogram; can be outside 14 days if applicable Prothrombin time with international normalized ratio (INR) =< ULN for the laboratory International normalized ratio (INR) < IULN or prothrombin time (PT) < IULN International normalized ratio (INR) =< IULN or prothrombin time (PT) =< IULN Prothrombin time/international normalized ratio (PT/INR) < 1.4 for patients not on warfarin Prothrombin time (PT)/international normalization ratio (INR) < 1.5 x ULN Within 3 months of registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin) Prothrombin time or international normalized ratio (INR) =< 1.5 X upper limit of normal (ULN) Prothrombin time (PT)/international normalized ratio (INR) < 1.7 unless using warfarin for therapeutic anti-coagulation Prothrombin time (PT) and international normalized ratio (INR) < 1.2 x ULN Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN (except for patients on anticoagulation) Prothrombin time (PT) or international normalized ratio (INR) =< 1.2 x institutional upper limit of normal (IULN) International normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless the patient is receiving anticoagulant therapy Prothrombin time (PT)/international normalized ratio (INR) =< 1.2 x ULN Evidence of a bleeding diathesis, coagulopathy or prothrombin time (PT) international normalized ratio (INR) > 1.5 International normalized ratio (INR)/prothrombin time (PT) =< 1.5 obtained =< 14 days prior to registration Coagulation: Prothrombin Time (PT) > 4 seconds more than the ULN or International Normalized Ratio (INR) > 1.7 Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN within 14 days prior to randomization; for laboratories that do not report an ULN for the INR assay, use =< 1.5 as the value for the ULN; patients receiving therapeutic anti-coagulants are not eligible PT/international normalized ratio (INR) ?ULN; aPTT ?ULN. International normalization ratio (INR) or prothrombin time (PT) ? 1.5 x International normalized ratio =< 1.5 and activated prothrombin time =< 1.5 x ULN for patients not receiving anti?coagulation therapy Prothrombin time (PT)/international normalized ratio (INR) within normal limits (+/- 15%) or within therapeutic range if on warfarin Patients with prothrombin time (PT) and/or international normalized ratio (INR) higher than or equal to 1.5 time upper limit of normal, unless patients have lupus anticoagulant in which case they are eligible if cleared by hematology Obtained within 30 days prior to registration: International normalized ratio (INR) or prothrombin time (PT) =< 2 x ULN (Note: use of vitamin K antagonist is not allowed) Cohort 2 (MTD) only: prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) within institutional normal limits Prothrombin time (PT)/international normalized ratio (INR) < 1.25 x ULN (Cohort II [MTD] only) International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN International normalized ratio (INR) =< 1.5 x ULN or prothrombin time (PT) =< 1.5 x ULN seconds above control unless patient is currently receiving warfarin therapy for the treatment or prevention of venous thrombosis Prothrombin time (PT), international normalized ratio (INR) less than 1.5 times the institutional upper limit of normal Prothrombin time (PT), international normalized ratio (INR) =< 1.5 x institutional ULN unless patient is therapeutically anticoagulated; if on anticoagulants, PT/INR need to be within appropriate anticoagulation limits for the clinical indication; patients who are receiving anticoagulants may participate in the trial if their anticoagulation can be stopped safely for several days at the time of each biopsy Prothrombin time (PT)/international normalized ratio (INR) monitoring, < 1.5 x institutional upper limits of normal Prothrombin time (PT)/international normalized ratio (INR) must be =< 1.2 x the laboratory ULN Prothrombin time (PT) within 2 seconds of the upper limit of normal (international normalized ratio [INR] =< 1.8) Adequate coagulation defined as\r\n* International normalized ratio (INR)/prothrombin time (PT) =< 1.5 x upper limit of normal Prothrombin time (PT)/international normalized ratio (INR) =< 2.3 or PT =< 6 seconds above control; if subjects are being anticoagulated they can participate if proof of no coagulation abnormality existed prior to use of anticoagulants Prothrombin time (PT) =< 26 seconds or international normalized ratio (INR) =< 2.5 Prothrombin time (PT) or international normalized ratio (INR) =< 1.2 x institutional upper limit of normal (IULN) (if not receiving anticoagulation therapy) INR ? 2.3 or Prothrombin time (PT) ? 6 seconds above control; Prothrombin Time - International Normalized Ratio (PT-INR) International Normalized Ratio (INR) or Prothrombin Time (PT) ?1.5 X ULN Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 14 days prior to study registration Prothrombin time international normalized ratio (INR) =< 2; AND International normalized ratio 1.5 × ULN or prothrombin time 5 seconds above ULN. Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.3 x upper limit of normal (ULN) Adequate prothrombin time/international normalized ratio (PT/INR) < 1.4 for patients not on warfarin confirmed by testing within 21 days prior to study registration Patients must have normal coagulation studies (prothrombin time [PT]/international normalized ratio [INR] < 1.5 times ULN) within 14 days prior to the initiation of study treatment Prothrombin time (PT)/international normalized ratio (INR) < 1.5 times upper limit of normal within 14 days before enrollment Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 times upper limit of normal (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) Prothrombin time (PT)-international normalized ratio (INR) =< 2.3 or PT =< 6 seconds above control Prothrombin time (PT) or international normalized ratio (INR) =< 1.2 x upper limit of normal (ULN) Concurrent treatment with warfarin (Coumadin) is allowed, but close monitoring of the prothrombin time (PT)/international normalized ratio (INR) is recommended Maximum Child-Pugh score of 5 (NOTE: this requires prothrombin time [PT] or international normalized ratio [INR] measurement at baseline) Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for the management of venous thrombosis including pulmonary embolus) Patients on stable anticoagulation are eligible for enrollment; for patients on warfarin, prothrombin time (PT)/international normalized ratio (INR) should be monitored every 2 weeks during induction therapy, monthly thereafter, or more frequent as clinically indicated Prothrombin time (PT) or international normalized ratio (INR) =< 1.2 X upper limit of normal (ULN) Prothrombin time (PT) or international normalized ratio (INR) =< 1.2 x ULN Prothrombin time (PT) or international normalized ratio (INR) =< 1.5 X institutional upper limit of normal (ULN) unless patients are on therapeutic anticoagulation with warfarin EXPANSION COHORT ONLY: Prothrombin time (PT) or international normalized ratio (INR) =< 2 X institutional upper limit of normal (ULN) unless patients are on therapeutic anticoagulation with warfarin Prothrombin time or international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) unless receiving therapeutic anticoagulation Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 Prothrombin time (PT) or International Normalized Ratio (INR) ? 1.25 x ULN; for patients with hepatocellular carcinoma only, INR <1.7 or prothrombin time (PT) or < 4 seconds above ULN (i.e. Child-Pugh Score is no greater than 1 for the coagulation parameter); for patients with hepatocellular carcinoma only, serum albumin > 2.8 g/dL (i.e. Child-Pugh Score for albumin is no greater than 2). For the hematologic malignancy patients, the coagulation and albumin status cited above do not apply Patient has acceptable coagulation status; for patients not receiving anticoagulation: international normalized ratio of a measure of prothrombin time =< 1.3 International normalized ratio (INR) >2.3 or prothrombin time (PT) >6 seconds above control Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 TPI 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their PT, PTT and international normalized ratio (INR). Prothrombin time (PT) with international normalized ratio (INR) ?1.5 Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN Prothrombin time/international normalized ratio (PT INR) < 1.4 Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolism) Evidence of active bleeding, a bleeding diathesis or prothrombin time (PT) international normalized ratio (INR) > 1.5 Prothrombin time International Normalized Ratio (INR) > 1.5 Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 Prothrombin time (PT) and/or international normalized ratio (INR) ? 1.3 × the upper limit of normal (ULN) Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) International normalized ratio (INR) or prothrombin time (PT) within normal institutional limits Obtained within 28 days prior to registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin) Patients should have international normalized ratio (INR) =< 1.4 and prothrombin time (PT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsy Complete blood count (CBC), chemistry panel (CMP) and coagulation panel (prothrombin time [PT] & international normalized ratio [INR]) no greater than 4 weeks prior to registration Within 2 weeks prior to registration: Subject has prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 x the laboratory upper limit of normal (ULN) Prothrombin time (PT)/ international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN Patients must have the following tests within 28 days prior to registration to obtain baseline measurements:\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR)/fibrinogen (all patients)\r\n* Neurologic assessment Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x upper limit of normal (ULN); subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization International normalized ratio (INR) < 1.5; partial thromboplastin time (PTT) < 1.5 upper limit of normal (ULN); d-dimer < 250ng/mL Patients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ?1.5 times ULN) Prothrombin time (PT)/international normalized ratio (INR)* =< 1.3 x upper limit of normal (ULN)\r\n* Subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization; PT and partial thromboplastin time (PTT) > 1.5 x ULN are permitted in these subjects The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of cabozantinib Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN) Prothrombin time (PT) / partial thromboplastin time (PTT); PT such that international normalized ratio (INR) =< 1.5 x ULN (unless a patient is on therapeutic warfarin) or a PTT =< 1.5 x ULN International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PPT) =< 5 seconds above the upper limit of normal (ULN) The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment Prothrombin time (PT)/partial thromboplastin time (PTT) ? 1.2 × ULN (unless receiving anticoagulation therapy, if receiving anticoagulation therapy, eligibility will be based upon international normalized ratio [INR]). Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin and a partial thromboplastin time (PTT) =< upper limit of normal Adequate Coagulation defined as prothrombin time (PT) and partial thromboplastin time (PTT) <= 1.2 x upper limit of normal and an international normalized ratio (INR) <= 1.2. The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment Adequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of ?1.5 × ULN Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN International normalized ratio (INR) ? 1.5 and partial thromboplastin time (PTT) ? 1.5 x ULN. Prothrombin time (PT) may be used instead of INR if ? 1.5 x ULN. Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (for patients on warfarin, INR should be maintained within therapeutic limits (either 2-3 or 2.5-3.5 for heart valve patients) The patient has adequate coagulation: prothrombin time (PT) and an International Normalized Ratio (INR), and partial thromboplastin time (PTT) ? 1.5 times the upper limit of normal (ULN), PHASE I: Prothrombin time (PT) (or international normalized ratio [INR]) and partial thromboplastin time (PTT) =< 1.5 x ULN International normalized ratio (INR)/partial thromboplastin time (PTT) has to be =< 1.5 x ULN Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) > 1.5 times the upper limit of normal Subject has prothrombin time/International Normalized Ratio or partial thromboplastin time test results at screening ?1.5 x ULN. Prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULN Adequate coagulation function as defined by International Normalized Ratio ?1.5 or prothrombin time ?1.5 x ULN, and partial thromboplastin time ?1.5 x ULN Coagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN Prothrombin time (PT)/ international normalized ratio (INR), partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN) Prothrombin time (PT)/ international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 28 days before the first dose of study treatment. Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test =< 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN). Prothrombin time (PT)/institutional normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Within 7 days before the first dose of study treatment: Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test < 1.3 x the ULN within 7 days before the first dose of study treatment Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder). The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory upper limit of normal (ULN) within 7 days before the first dose of study treatment International normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN International normalized ratio (INR) and activated partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN) provided the patient is not on anticoagulation therapy International normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; unless patient is on therapeutic anticoagulation Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional upper limit of normal; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to alternate assignment Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Prothrombin time/international normalized ratio (PT/INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN) FULL STUDY INCLUSION CRITERIA: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (Common Terminology Criteria for Adverse Events [CTCAE] grade =< 1)\r\n* Note: patients on stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and partial thromboplastin time (PTT) / activated (a)PTT test results are compatible with the acceptable benefit-risk ratio at the investigator’s discretion Serum coagulation studies (international normalized ratio [INR]/partial thromboplastin time [PTT]) and platelet counts suitable for surgery per surgeon discretion Prothrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 ULN Prothrombin time (PT) or international normalized ratio (INR) or partial thromboplastin time ?1.5 x ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to study drug administration may have PT/INR measurements >1.5 x ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to randomization. Abnormal coagulation parameters (prothrombin time [PT] > 15 seconds, partial thromboplastin time [PTT] > 40 seconds, and/or international normalized ratio [INR] > 1.5) Prothrombin time (PT)/international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT) (activated PTT [aPTT]) < 1.5 x ULN For patients undergoing serial tumor biopsies, international normalized ratio (INR) and activated partial thromboplastin time (PTT) must be within 1.5 X the upper limit of normal International normalized ratio (INR) =< 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment Prothrombin time (PT) with an international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) of =< 1.5 times the ULN; for patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT < 1.2 times the ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 X ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment Blood coagulation parameters: prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin or anticoagulants for management of venous thrombosis including pulmonary thrombo-embolus) and a partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN The subject has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x institutional ULN The subject has prothrombin time (PT)/International Normalized Ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment Normal blood coagulation as evidenced by partial thromboplastin time (PTT) < 1.5 IULN and international normalized ratio (INR) < 1.5 Abnormal prothrombin time (PT) (international normalized ratio [Inr]) > 1.5 INR or partial thromboplastin time (PTT) > 42 seconds (sec) (may be corrected with flash frozen plasma [FFP], cryoprecipitate, vitamin K, etc) Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x institutional ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x institutional ULN Prothrombin time (PT)/international normalized ratio (INR); partial thromboplastin time (PTT) =< 1.3; =< 1.3 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN for age Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ? 1.5 x ULN (except for subjects receiving anticoagulation therapy) International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless on anticoagulation therapy, in which case PT or partial thromboplastin time (PTT) should be in the therapeutic range Within 14 days prior to first dose of study drug treatment: International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN The subject has prothrombin time (PT)/institutional normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment INR (prothrombin time ratio) or partial thromboplastin time (PTT) > 1.5 x ULN (Please note: patients with hematopoietic cell transplantation (Hct) < 30%, WBC < 2500/mm/^3 and platelets < 50,000/mm^3 immediately prior to leukapheresis. The procedure may be deferred.) Prothrombin time (PT)/international normalized ratio (INR) less than or equal to 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) less than or equal to 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) performed within 3 weeks prior to starting study therapy must be =< 1.5 x ULN Serum prothrombin time, international normalized ratio (INR) and partial thromboplastin times which fall within normal limits or levels outside the normal range determined not to be clinically significant by the PI The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN =< 7 days before the first dose of study treatment Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5 International normalized ratio (INR) or partial thromboplastin time (PTT)/prothrombin time (PT) =< 1.5 ULN, unless the patient is on stable therapeutic dose of warfarin International normalized ratio INR/ prothrombin time (PT)/ partial thromboplastin time (PTT) each < 1.5 x ULN Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x ULN (or an in range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.5 times the upper limit of normal Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULN Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, international normalized ratio (INR) or platelet count (as determined by institutional lab parameters) at the time of screening Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulation Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with PT/INR/PTT established within the therapeutic range prior to randomization; subjects will be eligible if it is determined by a hematologist that the cause is not associated with clinical bleeding (e.g., deficiency of factor XII), within 2 weeks of the first dose of study treatment Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional upper limit of normal (IULN) (subjects on Coumadin are included if their coagulation is within a normal therapeutic range) Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal within 10 days prior to registration unless the patient is receiving coumadin and has a stable INR that is in range for the desired level of anticoagulation Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.5 x ULN International normalized ratio ?1.5 × ULN and partial thromboplastin time ?5 seconds above ULN. Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN Only for patients who test positive for hepatitis B virus or hepatitis C virus: partial thromboplastin time (PTT)/international normalized ratio (INR) =< ULN (institutional) Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN) Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN. Prothrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) =< 1.5 upper limit of normal (ULN) Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN Coagulation parameters: international normalized ratio (INR) =< 2, prothrombin time (PT) and partial thromboplastin time (PTT) < 1.5 X institutional ULN Normal prothrombin time (PT)/international normalized ratio (INR) and partial prothrombin time (PTT) Subjects with coagulopathies, including thrombocytopenia with platelet count < 75,000, international normalized ratio (INR) > 1.5 and partial thromboplastin time > 50 sec Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 and a partial thromboplastin time (PTT) =< 1.2 time the upper limit of normal unless the patient is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parameters Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 x ULN The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 × the laboratory ULN within 7 days before the first dose of study treatment Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5 The following laboratory values obtained =< 14 days prior to randomization\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 X ULN if not anticoagulated; within local institutional guidelines per local physician if anticoagulated Prothrombin time/international normalized ratio (INR) and partial thromboplastin time within normal limits Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x ULN unless on anticoagulation medication with stable dosing for at least one month; in addition, patient must be able to stop taking medication for up to a week in order to have percutaneous biopsies of tumor tissue performed No patients will have coagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% deviation of the institutional ULN Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on warfarin therapy, levels should be within therapeutic range Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN) International normalized ratio (INR) > 1.6 and a partial thromboplastin time (PTT) > 40 seconds Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN International normalized ratio (INR) < 2, prothrombin time (PT) < 20 sec, and partial thromboplastin time (PTT) < 55 sec Adequate coagulation system defined as an international normalized ratio (INR) of less than 1.4 and a partial thromboplastin time (PTT) of less than 34 The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the institutional ULN =< 7 days before the first dose of study treatment, unless PT/PTT prolongation known to be secondary to conditions not associated with increased bleeding risk (as on antiphospholipid antibody syndrome) Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal (ULN) Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization\r\n* NOTE: this applies to patient in the normal and renal dysfunction cohorts (N, R3 and R4); elevated PT/INR is allowed for patients in the liver dysfunction cohorts Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (Note: subjects receiving anticoagulation treatment may enroll with INR established within the therapeutic range prior to day 1 [D1] of treatment) The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 × the laboratory ULN within 7 days before the first dose of study treatment The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 X the laboratory ULN Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis) and a partial thromboplastin time (PTT) < 1.2 x ULN Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 X the ULN unless a subject is receiving Coumadin and has stable INR which is in range for the desired level of anticoagulation International normalized ratio (INR)/partial thromboplastin time (PTT) within 1.5 x upper limit of normal (Common Terminology Criteria for Adverse Events [CTCAE] 4.0 grade 1 abnormality is acceptable) The patient has an adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) or prothrombin time (PT) =< 1.5 x ULN, and partial thromboplastin time (PTT or aPTT) =< 1.5 x ULN (those receiving anticoagulation therapy except low molecular weight heparin are excluded) within 30 days prior to registration active, uncorrected bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, or INR at the time of HIFU (use international lab normal ranges for parameters); International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PTT) within normal limits; (patients who are on therapeutic anticoagulation with warfarin should have documentation of INR =< 1.5 or PTT within normal limits prior to initiating that therapy) Patients must have baseline prothrombin time (PT)/international normalized ratio (INR) < 3 x institutional upper limit of normal and partial thromboplastin time (PTT) < 3 x ULN within 7 days of initiating the induction cycle; (for patients with coagulation abnormalities that are correctable, coagulation factor support per institutional standard of care for AML is allowed) Subjects must have adequate coagulation as assessed by: international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN (CTCAE Grade <=1), partial thromboplastin time (PTT) <=1.5 x ULN (CTCAE Grade <=1) International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN International normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN Normal partial thromboplastin time (PTT) and either international normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN) The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 the laboratory ULN within 7 days before the first dose of study treatment The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULN Patients must have an International Normalized Ratio (INR) < 1.5 and a partial thromboplastin time (PTT) no greater than upper limits of normal within 1 week prior to randomization International normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate TPI 287 may interfere with Coumadin dosing and patients who are taking this combination will require monitoring of their prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR) Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 upper limit of normal (ULN) The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.5 x the laboratory ULN within 7 days before the first dose of study treatment The subject has prothrombin time/international normalized ratio (PT/INR) or partial thromboplastin time (PTT) test results at screening >= 1.5 x the laboratory upper limit of normal Prothrombin time (PT)-international normalized ratio (INR)/partial thromboplastin time (PTT) < 1.5 x ULN except in patients receiving active anticoagulation International Normalized Ratio (INR) and activated partial thromboplastin time [PTT] ? 1.5×ULN, if not therapeutically anticoagulated. Coagulation parameters: International normalised ratio (INR) < 2 and partial prothrombin Time (PTT) = 2xULN Patients must have prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal Prothrombin time (PT)/International normalized ratio (INR) and partial thromboplastin time (PTT) <=1.3xULN Coagulation parameters: International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN International normalized ratio (INR) and partial thromboplastin time (PTT) = 1.3 x ULN Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.2 x the upper limit of normal (ULN) unless receiving anticoagulation therapy. If receiving anticoagulation therapy, eligibility will be based upon International Normalization Ratio (INR) The participant either has adequate coagulation function as defined by international normalized ratio (INR) ? 1.5 and partial thromboplastin time (PTT) no more than 5 seconds above the ULN, or is on a stable dose of anticoagulant Prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULN Prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.2 X upper limit of normal (ULN) Evidence of bleeding diathesis or coagulopathy (partial thromboplastin time [PTT] and/or either prothrombin time [PT] or international normalized ratio [INR] > 1.5 x upper limit of normal) (except for subjects receiving anti-coagulation therapy); concurrent use of Coumadin or warfarin will be acceptable and monitoring patients on warfarin or Coumadin will follow the standard of care as dictated by the prescribing physician (PT/PTT); if the prescribing physician is not a Moffitt medical doctor (MD), then the prescribing MD will be notified by the research staff of the subject participating in the study, and monitors for PT, PTT will be obtained from patient during the 3 month study visit for review International normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN International Normalized Ratio (INR) ?1.5 and a partial thromboplastin time (PTT) ?5 seconds above the ULN. An international normalized ratio (INR) > 1.6, or a partial thromboplastin time (PTT) > 40 seconds Subjects unable to undergo routine endoscopy with biopsy:\r\n* Women who are pregnant or breastfeeding\r\n* Prothrombin time < 50% of control; partial thromboplastin time (PTT) > 50 sec, or international normalized ratio (INR) > 2.0\r\n* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues Partial thromboplastin time (PTT) greater than 50 seconds (sec) or international normalized ratio (INR) greater than 2.0 Prior anticoagulant therapy use is allowed provided therapy is discontinued at least 7 days prior to the breast biopsy in order to reduce the risk of bleeding. For participants who have taken an anticoagulation within the past 7 days, international normalized ratio must be ? 1.5 x institutional upper limit of normal and prothrombin time and partial thromboplastin time ? ULN prior to the breast biopsy. Subjects with coagulopathies, including thrombocytopenia with platelet count < 75,000, international normalized ratio (INR) > 1.5 and partial thromboplastin time > 50 sec International Normalized Ratio (INR) and activated Partial Thromboplastin Time [PTT] within normal institutional limits Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 times institutional upper limit of normal Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 1.5 × ULN; unless the patient is on a therapeutic anticoagulant Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x institutional upper limit of normal (within 14 days of study registration) Patients with abnormal prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) or bleeding diathesis Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 X upper limit of normal (ULN) The patient has adequate coagulation: prothrombin time (PT), partial thromboplastin time (PTT), and an International Normalized Ratio within normal limits. Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio [INR]) are eligible Adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal; patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin Within 3 weeks prior to study registration: \r\nInternational normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN within 3 weeks prior to study registration; subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists ; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control Adequate coagulation function as defined by International Normalized Ratio (INR) =< 1.5 and partial thromboplastin time (PTT) =< 5 seconds above the ULN (unless receiving anticoagulation therapy); patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy International normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN; (subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care International normalized ratio (INR) =< 1.5; (anticoagulation with low molecular weight heparin is allowed if on a stable dose for > 2 weeks at time of enrollment) International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN prior to study entry. Therapeutic anticoagulation with warfarin is allowed if target INR =< 3 on a stable dose of warfarin or on a stable dose of low molecular weight (LMW) heparin for > 2 weeks (14 days) at the time of enrollment. International normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; (subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists) Anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of anticoagulant for > 2 weeks at time of randomization; for patients on therapeutic anti-coagulants, medication must be clinically held peri-procedure (bone marrow aspirate) per standard clinical management International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN within 14 days prior to study entry; therapeutic anticoagulation with warfarin is allowed if target INR =< 3 on a stable dose of warfarin or on a stable dose of low molecular weight (LMW) heparin for > 2 weeks (14 days) at the time of enrollment International normalization ratio (INR) < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy International normalization ratio (INR) < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy International normalized ratio (INR) > 2 and/or partial thromboplastin time (PTT) > 80\r\n* Patients who are on anticoagulation medication that may not be safely held for the procedure (>= 5 days for antiplatelet agents and warfarin; >= 24 hours for low-molecular weight heparin formulations) will be excluded REGORAFENIB INCLUSION CRITERIA: International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN (patients who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate, provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is predose as defined by the local standard of care) Prothrombin (PT) and activated partial thromboplastin time (aPTT) =< 1.2 x upper limit of normal (ULN) prior to biopsy; patients with prior history of thrombosis/embolism are allowed to be on anticoagulation, understanding that anticoagulation will be held in the perioperative period per the neurosurgical team’s recommendations; low molecular weight heparin (LMWH) is preferred; if a patient is on warfarin, the international normalized ratio (INR) is to be obtained and value should be below 2.0 prior to biopsy International normalized ratio (INR) > 2.5 and/or partial thromboplastin time (PTT) > 80 \r\n* Patients who are on anticoagulation medication that may not be safely held for the procedure (>= 5 days for antiplatelet agents and warfarin; >= 24 hours for low-molecular weight heparin formulations) will be excluded International normalized ratio (INR) =< 1.5; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at the first dose of study agent) Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the international normalized ratio (INR) should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable The subject has adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x ULN\r\n* Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy International normalized ratio (INR) =< 1.5; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of randomization) International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PTT) =< 1.5 x ULN for patients who are not being treated with therapeutic anticoagulation; therapeutic or prophylactic anticoagulation is allowed if a patient has been on a stable dose of low molecular weight (LMW) heparin for > 2 weeks at the time of randomization; subjects on therapeutic or prophylactic anticoagulation including warfarin will have PTT and INR as determined by the Investigator; prophylactic use of an anticoagulant to maintain patency of a vascular access device is also allowed) International normalized ratio (INR)/ partial thromboplastin time (PTT) < 1.5 x ULN; (subjects who are treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring [day 5 of cycle 1 and day 1 of each cycle] is mandatory) will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care) International normalized ratio of prothrombin time (INR) within 28 days before randomization must be =< ULN for the lab; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history International normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; (patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care) International normalized ratio (INR) < 1.2 times ULN; (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met) International normalized ratio (INR) =< 1.5, and a partial thromboplastin time (PTT) =< 5 seconds above the ULN (unless receiving anticoagulation therapy); patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy International normalized ratio of prothrombin time must be less than or equal to 1.5 times the ULN. Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history. SUB-PROTOCOL AIM A: Adequate coagulation function as defined by either of the following criteria:\r\n* International normalized ratio (INR) =< 1.5 x ULN\r\n* For subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the investigator’s opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy; the INR for these patients may exceed 1.5 x ULN if that is the goal of the anticoagulant therapy International normalized ratio (INR)/ Partial thromboplastin time (PTT) ? 1.5 x ULN. (Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care. Coagulation • INR less than or equal to 1.5 x ULN (or in range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin). International normalized ratio (INR) 2 weeks at time of randomization International normalized ratio (INR) =< 1.2 x ULN; partial thromboplastin time (PTT) =< 1.5 x ULN, within 14 days of registration; therapeutic anticoagulation with warfarin is allowed if target INR =< 3 on a stable dose of warfarin or on a stable dose of low molecular weight (LMW) heparin for > 2 weeks (14 days) at time of randomization International normalized ratio (INR) =< 2.0; anticoagulation is allowed if target INR =<, 2.0 on a stable dose of warfarin or if patient on a stable dose of low molecular weight (LMW) heparin for > 1 weeks at time of enrollment International normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN\r\n* Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of randomization) International normalize ratio (INR) and the partial thromboplastin time (PTT) < 1.5 x ULN. (Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists) Prothrombin time (PT-INR)/ partial thromboplastin time (PTT) ? 1.5 x ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement that is pre dose as defined by the local standard of care International normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN (subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care) International normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is defined by the local standard of care International normalized ratio of prothrombin time and activated partial thromboplastic time 2 weeks at time of registration Coagulation studies with prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) within normal limits (± 15%); if the patient is on Coumadin – we would switch the patient to low molecular weight (LMW) heparin product such as fondaparinaux (Arixtra) or enoxaprin (Lovenox); an anti-factor Xa test should be available demonstrating adequate anti-coagulation on the low molecular weight heparin (LMWH) (therapeutic range 0.4-0.8); however, if this is not possible then INR must be kept =< 3 International normalized ratio (INR) and partial thromboplastin (PTT) =< 3.0 x ULN (anticoagulation is allowed if target INR =< 3.0 x ULN on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of registration) NOTE: subjects may not have had a transfusion within 7 days of screening assessment; NOTE: patients who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until PT/INR is stable based on a measurement that is pre-dose as defined by the local standard of care International normalized ratio (INR) < 1.5 and a partial thromboplastin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly (INR must be therapeutic in the range of 2-3) International normalized ratio (INR) =< 1.5; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of study initiation) International normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable Prothrombin time (PT) (international normalized ratio [INR]) > 1.5, unless the patient is on full dose anticoagulants; if so, the following criteria must be met for enrollment:\r\n* The subject must have an in-range INR (usually between 2-3) on a stable of low molecular weight heparin; anticoagulation with warfarin is not allowed PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists]. Low-dose aspirin is permitted ( 2 weeks at the time of registration) International normalized ratio (INR) of prothrombin time (PT; PT-INR) and activated partial thromboplastin time (aPTT) =< 1.5: subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists per medical history; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care International normalized ratio (INR) < 1.5 x ULN unless patients are receiving anti-coagulation therapy; patients receiving anti-coagulation therapy with an agent such as warfarin or heparin are allowed to participate if INR =< 3.0 Adequate blood clotting as defined by international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ? 1.5 times ULN (patients on anticoagulation with an agent such as warfarin or heparin or rivoraxaban will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists). For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care