Within 10 days of treatment initiation: Prothrombin time (PT) and partial thromboplastin time (aPTT) =< 1.5 X institutional upper limit of normal (IULN) Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN Prothrombin time (PT)/partial thromboplastin time (PTT) =< 2 times normal; timeline: within 3 weeks prior to enrollment or If requires pheresis to collect blood, prothrombin time (PT) < 1.5 upper limit normal Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy PART I: Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x the upper limits of normal Normal prothrombin time (PT) Normal prothrombin time (less than or equal to 15.2 seconds) Prothrombin time (PT)/partial thromboplastin time (PTT) > 1.5 upper limit of normal (ULN) Prothrombin time (PT)/partial thromboplastin time (PTT) less than 1.5 times normal Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x ULN Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.5 times upper limit of normal Prothrombin time (PT) ?1.5 × ULN (Grade ?1). Prothrombin time (PT) > 16.5 seconds or Prothrombin time (PT) within normal limits (WNL)+/- 15 % unless on active anticoagulation obtained ? 14 days prior to randomization Prothrombin time (PT)/partial thromboplastin time (PTT) ? 1.5 times the ULN Prothrombin time (PT) no more than 2 seconds above the upper limits of normal (ULN) Within 7 days (+ 3 day window) of enrollment: Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x the institutional upper limit of normal (ULN), (this will not apply to subjects with confirmed Factor XII deficiency) Prothrombin time (PT) and partial thromboplastin time (PTT) must be =< 2 x the upper limit of the institution's normal range, at the time of enrollment Obtained =< 28 days prior to registration: Prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) unless patient is receiving anticoagulant therapy and PT or partial prothrombin time (PTT) is within therapeutic range of intended use of coagulants Prothrombin time (PT) < 1.5 Hepatic: Total bilirubin 1.5 x ULN; transaminases ? 2.5 x ULN (may be up to 5 x ULN if clearly due to liver metastases); prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x (ULN). A Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) within normal range Prothrombin time (PT) =< 1.5 x ULN Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x ULN Obtained within 14 days prior to registration; prothrombin time and partial thromboplastin time (PT / PTT) ? 50% increase from institutional ULN Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN) Prothrombin time (PT) < 1.5 Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT No baseline prothrombin time (PT)/partial thromboplastin time (PTT) abnormalities, coagulopathies, or who are on any blood thinners Prothrombin time =< 1.5 x upper limit of normal (ULN) obtained within 14 days of first treatment Prothrombin time (PT) =< 1.5 x ULN Prothrombin time (PT) =< 1.5 x institutional upper limit of normal (ULN) Prothrombin time (PT) < 14 sec; partial thromboplastin time (PTT) < 35 sec Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.5 x ULN Prothrombin time (PT) and partial thromboplastin time (PTT) < 50% of deviation from institutional upper limit of normal (IULN) Normal prothrombin time (PT) for age Prothrombin time (PT) no greater than 6 seconds longer than control. Prothrombin time (PT) < 1.3 x upper limit of normal (ULN) Prothrombin time (PT) with normal limits (WNL); if patient is on warfarin for prophylactic clot presentation for indwelling catheter, PT/partial thromboplastin time (PTT) may be +/- 15 % Evidence of bleeding diathesis or coagulopathy as documented by an elevated prothrombin time (PT), partial thromboplastin time (PTT) or bleeding time Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (secpatient may be eligible for trial if abnormality is deemed clinically insignificant and cleared for protocol therapy by Hematology Consult service) Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.4 times upper limit of normal range Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x normal outside the setting of stable chronic anticoagulation therapy Prothrombin time less than 1.5 × ULN for the institution Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4 x ULN HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4 x ULN Prothrombin time (PT) and/or partial thromboplastin time (PTT) =< 1.5 X ULN. Prothrombin time/partial thromboplastin time (PT/PTT) ? 1.5 x upper limit of normal (ULN) (unless receiving anticoagulation) Prothrombin time (PT) =< 1.5 x ULN Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.5 x of institutional upper limit of normal (ULN) (Note: If coagulopathy is related to disease, this criteria do not apply) within 14 days prior to registration Prothrombin time (PT)/partial thromboplastin time (PTT) < 1.5 x normal institutional standard Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ? 1.6x unless therapeutically warranted Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (11.6 - 15.2 / 25.3 - 37.3 sec) Prothrombin time (PT) > 12 seconds or partial thromboplastin time (PTT) > 31 seconds Prothrombin time (PT) within 2 seconds of the upper limit of normal (ULN) Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x ULN Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Prothrombin time (PT) =< 1.2 x ULN Prothrombin time (PT) and partial thromboplastin time (PTT) within 1.5 times the institutional upper limit of normal Normal coagulation [prothrombin time and partial thromboplastin time within normal limits (±15%)]. Prothrombin time (PT) or partial thromboplastin time (PTT) test >= 1.3 x laboratory upper limit of normal (ULN) within 7 days before the first dose of study treatment Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.5 X ULN after correction of nutritional deficiencies that may have contributed to prolonged PT/PTT. AMKL PATIENTS: Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN Coagulation: Prothrombin time (PT) <1.5 × ULN and partial thromboplastin time (PTT) <1.5 × ULN Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (+/-15%). Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULN Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional upper limit of normal (ULN) Prothrombin time (PT) =< 1.5 times the upper limit of normal Prothrombin time (PT) within normal limits (UIHC) Adequate coagulation defined as:\r\n* Prothrombin time (PT) =< 1.2 x upper limit of normal Prothrombin time (PT) < 1.2 x ULN Patients must NOT have a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) (greater than 1.2 times the institutional upper limit of normal) Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN Other: Prothrombin time (PT) and partial thromboplastin time (PTT) < ULN. Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x ULN Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Normal prothrombin time (PT)/partial thromboplastin time (PTT) prothrombin time (PT) and activated partial thromboplastin time (PTT) ? 1.6 x control unless therapeutically warranted Prothrombin time (PT) and partial thromboplastin time (PTT) must not be more than 1.5 x upper limit of normal (ULN) within 72 hours prior to enrollment; PT and PTT should be drawn by venipuncture, rather than from a central venous catheter when feasible Prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x normal outside the setting of stable chronic anticoagulation therapy Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limits of normal Prothrombin time (PT) and partial thromboplastin time =< 1.5 upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulation Subjects must have normal coagulation parameters as measured by prothrombin time (PT)/partial thromboplastin time (PTT) Prothrombin time (PT)/INR and partial thromboplastin time (PTT) =< grade 1 within two weeks before initial biopsy of visceral organs Prothrombin time (PT) =< 2 x normal outside the setting of stable chronic anticoagulation therapy Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.2 X upper limit normal (ULN) Prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x normal outside the setting of stable chronic anticoagulation therapy Prothrombin time (PT) and partial thromboplastin time (PTT) =< 120% of control, unless patient has the presence of a lupus anticoagulant Prothrombin time (PT), partial thromboplastin time (PTT) less than or equal to 1 to 1.5 x upper limit of normal, CTCAE v 4.0 grade 1 except for patients on therapeutic anticoagulation Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 X ULN Prothrombin time < 1.5 x ULN Normal prothrombin time Prothrombin time (PT) ? 1.5 x ULN TREATMENT: Prothrombin time (PT) within 2 seconds of the upper limit of normal (ULN) Coagulation status: prothrombin time (PT) ? 1.5 ULN or INR within normal limits; and partial thromboplastin time (PTT) ? 1.2 × ULN No evidence of coagulopathy as indicated by prothrombin time (PT) =< 1.5 X upper limit of normal Patients with known bleeding diathesis or prothrombin time (PT) or aPTT >1.5 x ULN or fibrinogen <0.5 x LLN PART I: Absolute neutrophil count (ANC), hemoglobin, platelet, total bilirubin, creatinine, transaminase (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]), prothrombin time (PT), partial thromboplastin time (PTT), urine uric acid, urine pH, urine oxalate must be within standard normal ranges Prothrombin time (PT)/partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN) Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (IULN) Prothrombin time (PT) =< 4 seconds above upper limit of normal (ULN) and partial thromboplastin time (PTT) =< 10 seconds above ULN Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution Prothrombin time (PT) or partial thromboplastin time (PTT) > 1.5 x the upper limit of normal, except if the patient is on therapeutic anticoagulation, in which case they should demonstrate stability of PT/PTT for at least two weeks Prothrombin time (PT) < 1.5 ULN Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN) Prothrombin time (PT) no more than 2 seconds above the upper limit of normal (ULN) Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN) Prothrombin time > 1.5 x control Have a bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and platelet count < 140,000 platelets per microliter of circulating blood1 Prothrombin time (PT) and partial thromboplastin time (PTT) > 1.5 x ULN Prothrombin time (PT) and partial thromboplastin (PTT) =< 1.5 x IULN Prothrombin time greater than 50% of control Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal Prothrombin time (PT)/partial thromboplastin time (PTT) within normal institutional limits Presence of coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] > 1.2 x upper limit of normal) Thrombin time (TT), prothrombin time (PT), or partial thromboplastin time (PTT) > 2 x upper limit of normal Patients not taking warfarin must have prothrombin time (PT)/partial thromboplastin time (PTT) levels =< 1.5 times the upper limit of normal provided by the reference laboratory performing the test Prothrombin time (PT)/partial thromboplastin time (PTT) within normal institutional limits PT/PTT/INR (prothrombin time/partial thromboplastin time) without clinically significant abnormalities after review by the study physicians Contraindication to biopsy:\r\n* Bleeding disorders\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT) >= 1.5 times the upper limit of normal\r\n* Artificial heart valve Patients with coagulopathies who are at increased risk for bleeding or on active anti-coagulation therapy (platelets less than 100,000 per mm^3 or prothrombin time [PT]/partial thromboplastin time [PTT] greater than 1.5 times the upper normal limit [UNL]); patients are eligible if the underlying cause is correctable Prothrombin time (PT)/partial thromboplastin time (PTT) =< the institution ULN Prothrombin time > 1.5 x control Coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] > 1.5 x upper limit of normal) Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.5 times upper limit of normal