For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
Not currently receiving anticoagulation therapy
Need for anticoagulation
Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors
Current use of anticoagulation therapy
INR ? 1.6 (unless receiving anticoagulation therapy).
Subjects receiving anticoagulation therapy
concomitant use of therapeutic anticoagulation
Treatment with anticoagulation or antiplatelet agents, except for aspirin dosages of ?100 mg per day, within the last 2 weeks
For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment
Requirement for chronic anticoagulation
Transaminases ? 2 times above the upper limits of the institutional normal, - INR<2 (international normalized ratio) 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 and if the site to be injected is not located in the oropharynx or another area where achieving homeostasis would be complicated by local anatomy.
On anticoagulation and unable to discontinue temporarily
Requires therapeutic doses of anticoagulants unless anticoagulation can be safely discontinued before surgery per standard practice (e.g. first deep vein thrombosis [DVT] for which anticoagulation has been at least 3 months and repeat imaging demonstrates resolution of DVT) or an inferior vena cava (IVC) filter can be used in place of anticoagulation; subjects are permitted to resume anticoagulation following surgery per discretion of treating physician and/or site standard operating procedures (SOPs)
Require therapeutic use of anticoagulation medications
Patients on therapeutic or prophylactic anticoagulation will be excluded from enrollment on the protocol; however, patients can remain on the study if they develop a thrombosis that requires therapeutic anticoagulation during the course of protocol therapy
Subject is actively on anticoagulation therapy.
Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
Subjects receiving anticoagulation therapy
Patient has a bleeding disorder or a screening platelet count <100×109/L, or requires continuous anticoagulation or bridging anticoagulation during the procedure
Patients who require ongoing anticoagulation will be excluded. Only aspirin will be permitted. Pre and post-surgical prophylactic anti-coagulation treatment is permitted
Pulmonary embolism (PE) in the 3 months before enrollment; anticoagulation is permitted as long as stable dosage for more than 3 months
Patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation
FOR ALL PHASES (Ib AND II): Participants receiving anticoagulation therapy are not allowed
Requires use of therapeutic anticoagulation prior to registration\r\n* NOTE: thromboprophylaxis with any agent is permitted
Patients judged by their urologist or preoperative evaluation center (PEC) center to be unsafe to forgo pharmacologic prophylaxis or systemic anticoagulation postoperatively (whether or not they are on systematic anticoagulation for indications other than VTE)
Requires concomitant therapeutic anticoagulation (i.e., warfarin) for reasons other than venous catheter patency
Contraindication to biopsy or prostatectomy (for neoadjuvant cohort only):\r\n* Bleeding disorders\r\n* Artificial heart valve\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT) >= 1.5 x ULN in patients not taking anticoagulation; patients on anticoagulation (e.g. enoxaparin, oral anticoagulants) are eligible regardless of PT/PTT; prior to biopsy, anticoagulation will be held per standard practice
anticoagulation with inability to stop anticoagulants prior to surgery
Is on anticoagulation that cannot be discontinued in the perioperative stage
Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low dose DVT or line prophylaxis is allowed).
Patients on anticoagulation therapy which cannot be held for metastatic biopsies
Abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants (that cannot be safely held for biopsy) that would preclude tumor and skin biopsies\r\n* For fulvestrant: ongoing anticoagulation that would preclude an IM injection\r\n* For tamoxifen: documented hypercoagulable state not receiving anticoagulation
Unable or unwilling to take any prophylaxis; patients with history of or new/active deep vein thrombosis/embolism/thrombophilia are allowed to participate if they are on appropriate therapeutic anticoagulation during the treatment on the trial; these patients would not need the aspirin with the lenalidomide unless clinically indicated; therefore, patients must be able and willing to receive anticoagulation (prophylaxis versus therapeutic as clinically indicated)
Patients who require ongoing anticoagulation will be excluded; only aspirin will be permitted; pre and post-surgical prophylactic anti-coagulation treatment is permitted
Patients on therapeutic anticoagulation; Note: prophylactic anticoagulation (i.e. intraluminal heparin) for venous or arterial access devices is allowed
Need for ongoing therapeutic anticoagulation
Subject is receiving anticoagulation; washout period of 7 days
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Chronic anticoagulation, not including aspirin, but including heparins, warfarin, oral anticoagulation or other platelet function inhibitors
Patients receiving therapeutic non-Coumadin anticoagulation are eligible, provided they are on a stable dose (per investigator judgment) of anticoagulant
Patients on therapeutic anticoagulation
Patients requiring therapeutic anticoagulation and irreversible platelet inhibitors (e.g. clopidogrel, prasugrel, or ticagrelor). Low dose aspirin for cardiac prophylaxis is allowed.
Current use of anticoagulation; NOTE: use of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter is allowed
Patients with TE event occurring > 6 months prior to enrollment and receiving active anticoagulation
Patients requiring therapeutic anticoagulation
Patients on therapeutic anticoagulation Note: prophylactic anticoagulation (i.e. intraluminal heparin) for venous or arterial access devices is allowed
Patients must not be on any anticoagulation
Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
Therapeutic anticoagulation is not contraindicated, but for those patients on therapeutic anticoagulation, alteration in coagulation parameters is expected following initiation of dasatinib; for patients on therapeutic anticoagulation, coagulation parameters should be assessed weekly for the first cycle following initiation of dasatinib, weekly for the first cycle following a dose reduction, and weekly for a minimum of two weeks after stopping dasatinib
Anticoagulation with Lovenox (enoxaparin) is permitted, however, patients on anticoagulation with warfarin are not permitted on this study
Require therapeutic anticoagulation treatment, especially with Coumadin
Concomitant anticoagulation, at therapeutic doses, with anticoagulants.
Patients on oral anticoagulation therapy
In the absence of therapeutic intent to anticoagulate the patient: INR > 1.5 or PT > 1.5 xULN or aPTT > 1.5 xULN Therapeutic anticoagulation.
Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.
Prothrombin Time or INR ?1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation.
Concomitant medications: patients receiving anticoagulation should be on stable dose 2 weeks prior to registration
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Chronic anticoagulation, not including aspirin, but including heparins, warfarin, oral anticoagulation or other platelet function inhibitors, that can not, in the documented opinion of the investigator, safely be interrupted from at least 2 days prior to the initiation of the study regimen until after surgical resection of the tumor.
Concurrent treatment with anticoagulation medication, unless approved by Sponsor
Patients using oral or parenteral anticoagulation are not excluded provided they are on a stable dose of anticoagulant
Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment;
Patients must not be receiving therapeutic anticoagulation
Patients requiring anticoagulation or with uncontrolled bleeding are excluded
Subjects requiring therapeutic doses of anticoagulation or anti-platelet therapies (aspirin above 81 mg daily, Plavix or similar agents) AND platelet counts are below 50,000 on two different laboratory evaluations, separated by minimum of two weeks
Patients on active therapeutic anticoagulation
Anticoagulation is permitted but patients may only be on lovenox for this purpose.
Ongoing therapy with oral or parenteral anticoagulants; low-dose anticoagulation to maintain patency of lines is allowed
Stable dose Coumadin anticoagulation is allowed, providing that anticoagulation can be safely held to an international normalized ratio (INR) within normal range for the purpose of tumor biopsy; low molecular weight heparin (LMWH) is the preferred method of anticoagulation
Active bleeding tendency; NOTE: patients on therapeutic anticoagulation should be monitored carefully to maintain therapeutic level of anticoagulation to avoid increased risk of bleeding due to concurrent drug induced thrombocytopenia; it is suggested that patients who require anticoagulation therapy while on therapy use low molecular weight heparin (LMWH)
Concomitant anticoagulation with oral anticoagulants.
Prothrombin time or INR =< 1.5 x ULN unless receiving therapeutic anticoagulation
Patients on chronic anticoagulation such as Aspirin, Plavix, or Coumadin who cannot have anticoagulation held for procedures are not eligible
use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped;
If on anticoagulation, participant must be on stable therapeutic dose prior to enrollment
Coagulopathy or anticoagulation therapy that cannot be safely corrected or interrupted for tumor biopsy
Prothrombin time (PT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on anticoagulation therapy, levels should be within therapeutic range, or
Current use of therapeutic anticoagulation therapy
Had full-dose anticoagulation with heparin, enoxaparin, dalteparin, other LMWH, a/or other anticoagulants w/in 90 days before first dose of M402
Evidence of bleeding diathesis or coagulopathy; patients that are on anticoagulation therapy for deep vein thrombosis (DVT) will be allowed to enroll and continue on the treatment dose of enoxaparin or other anticoagulation such a warfarin
Patients must not be on any anticoagulation
Able to take required prophylactic anticoagulation.
History of bleeding diathesis, known factor X deficiency (level < 20%), or requirement for therapeutic anticoagulation with warfarin
Active therapeutic anticoagulation
Therapeutic anticoagulation
Patients on fibrinolysis, full-dose therapeutic anticoagulation, or high dose antiplatelet therapy
Continuous anticoagulation therapy; patients who were on anticoagulant therapy must complete a washout period of at least 10 days and have confirmed normal coagulation parameters before study inclusion
Patient receiving anticoagulation
Use of therapeutic anticoagulation within 5 days of surgery (not including venous thromboembolism prophylaxis)
Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
Documented venous thromboembolism while on therapeutic anticoagulation (“anticoagulation failure”)
Currently receiving anticoagulation treatment
Current oral steroid use or receiving daily therapeutic anticoagulation (e.g. Coumadin, Lovenox)
Documented venous thromboembolism while on therapeutic anticoagulation (“anticoagulation failure”)
Require chronic anticoagulation or anti-platelet therapy
Women on anticoagulation
Protein C deficiency (increased risk of skin necrosis do those on injectable anticoagulation)
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Require chronic anticoagulation or anti-platelet therapy
Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week
a condition requiring prolonged anticoagulation or anti-platelets
Subjects on anticoagulation (other than aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement)
Subjects on anticoagulation (other than aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement)
Patients who require anticoagulation for whom biopsy would be contraindicated.
Active therapeutic anticoagulation
Patient receiving therapeutic anticoagulation
Subjects requiring anticoagulation not eligible
Require therapeutic use of anticoagulation medications