International normalized ratio (INR) =< 1.4 unless receiving therapeutic doses of coumadin 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) =< 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 International normalized ratio (INR) =< 1.5 x institutional ULN International normalized ratio (INR) < 1.3 x ULN International normalized ratio (INR) =< 1.4 Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of- therapeutic range international normalized ratio (INR) (> 3) within the 4 weeks prior to drug administration Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio [INR]) are eligible ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): International normalized ratio (INR) =< 3 (to be done/tested only for subjects on warfarin) Prothrombin time or international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) Hematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and partial thromboplastin time (PTT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsy 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) < 1.5 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 International normalized ratio (INR)/PTT =< 2 times normal; timeline: within 3 weeks prior to enrollment International normalized ratio (INR) =< 2 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 Hematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and partial thromboplastin time (PTT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsy Hematologic parameters for patients undergoing biopsy only: 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 International normalized ratio (INR) =< 1.5 Within 28 days prior to administration of study treatment: Coagulation parameters (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, or except patients on anticoagulation International normalized ratio (INR) =< 1.5 International normalized ratio (INR) =< 1.5 International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN International normalized ratio (INR) =< 1.5