Chronic therapy with non-steroidal anti-inflammatory agents or other anti-platelet agents.
Patients currently receiving aspirin, and/or ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs) are not eligible
Use of salicylates, non-steroidal anti-inflammatory drugs, or sulfonamide medications within one week of start of methotrexate
ibuprofen or to more than one non-steroidal anti-inflammatory drug.
Anticoagulation and anti-platelet therapies are not permitted (this includes Coumadin, low molecular weight heparins, factor Xa inhibitors, aspirin and non-steroidal anti-inflammatory drug [NSAIDS] or other medicines with similar effects)
Patients who are chronically receiving aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs are not eligible
Concomitant systemic treatment with chronic use (based on the investigator’s judgment) of corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs, and other platelet inhibitory agents
Current anticoagulant or antiplatelet aggregation therapy except for aspirin or non-steroidal anti-inflammatory drugs
Use of non-steroidal antiandrogens (e.g., flutamide, nilutamide, or bicalutamide) within 6 weeks of registration
Anti-androgens (steroidal or non-steroidal) such as cyproterone acetate, flutamide, nilutamide, bicalutamide, etc. other than assigned study drug unless given for =< 4 weeks.
Must be on stable doses of any drugs affecting hepatic drug metabolism or renal drug excretion (e.g. non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates, diphenylhydantoin, narcotic analgesics, probenecid). Such drugs should not be initiated less than 30 days prior to Baseline/C1D1 or at any time during study participation. Whenever possible, narcotic analgesic doses should be stable within 30 days prior to study entry and during the first cycle of therapy.
Concomitant chronic (daily or almost daily for >= 1 month prior) use of steroids or non-steroidal anti-inflammatory drugs (NSAIDS)
Inability to interrupt use of non-steroidal anti-inflammatory drugs (NSAIDS)
Patients at risk for gastrointestinal bleeding (example: peptic ulcer disease, prolonged daily non-steroidal anti-inflammatory use)
Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins)
Subjects who have a hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins
Has contraindication to administration of non-steroidal anti-inflammatory drugs (NSAIDS)
Significant immunosuppression from concurrent, recent (=< 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti-inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy.
Concurrent use of high dose aspirin (doses up to 81 mg oral dose daily allowed) and non-steroidal anti-inflammatory drugs (NSAIDS), except for where NSAIDs provide documented benefit over other analgesics, and then to be used with caution including concomitant use of proton pump inhibitors).
Prior use of non-steroidal anti-androgens (e.g., bicalutamide, flutamide, nilutamide) within 1 month before registration
Concomitant systemic treatment with chronic use of anti-histamine or non-steroidal anti-inflammatory drugs and other platelet inhibitory agents and patients on oral anticoagulant (e.g. warfarin)
Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs except in association with preparative regimen and NK cell infusion; any cyclooxygenase (COX)-2 inhibitors are permitted
Patients who are currently receiving aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs or anti-platelet agents are not eligible
Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs; any cyclooxygenase-2 (COX-2) inhibitors are permitted
Subjects should be willing and able to take folic acid and vitamin B12 supplementation and should interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long acting agents such as piroxicam) before entering the study
Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti-inflammatory drugs and aspirin permitted) or conditions such as common variable hypogamma-globulinemia or exposures such as large field radiotherapy
Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti- inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy
Use of anti-coagulant agents or history a significant bleeding diathesis. (If a superficial lymph node or subcutaneous mass is to be injected, patients on agents such as non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or clopidogrel are eligible and these agents do not have to be withheld. For procedures with moderate or significant risk of bleeding, long-acting agents such as aspirin or clopidogrel should be discussed with the Medical Monitor and may need to be discontinued before G100 therapy. For patients enrolled in Part 2 with the potential to receive pembrolizumab:
Patients are excluded if they have current or recent (within 10 days of enrollment) use of aspirin (> 325 mg/day) or chronic use of other non-steroidal anti-inflammatory drugs (NSAID)
Patients currently taking medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug)
Patients receiving any of the following medications are not eligible for study:\r\n* Anti-cancer therapy or investigational agents\r\n* Anti-coagulants (except for heparin to maintain the patency of central venous catheters)\r\n* Growth factors for white blood cell, red blood cell or platelet support\r\n* Aspirin (> 81 mg/day)\r\n* Non-steroidal anti-inflammatory drugs\r\n* Clopidogrel (Plavix), dipyridamole (Persantine), or any other drug that inhibits platelet functions\r\n* Anti-convulsants: patients on any anti-convulsant with the exception of VPA are eligible for study entry; it is STRONGLY RECCOMMENED that a neurology consult be obtained to enable discontinuation of all anticonvulsant other than VPA, whenever possible
Any drugs or supplements that interfere with blood clotting can raise the risk of bleeding during treatment with bevacizumab. These drugs include vitamin E, non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), and naproxen (Aleve, Naprosyn), warfarin (Coumadin), ticlopidine (Ticlid), and clopidogrel (Plavix).These agents should be used with caution.
Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
Subjects may not initiate a new form of cancer therapy, non-steroidal or steroid anti-inflammatory agents, or antibiotics during the study period or for 4 weeks prior to the start of study agents
Any uncontrolled systemic inflammatory disease or infection requiring antibiotics, non-steroidal, or steroidal anti-inflammatory agents on a daily basis
Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
Patients requiring > 325 mg per day or non-steroidal anti-inflammatory medications known to inhibit platelet function; patients taking cyclooxygenase-2 (COX2) inhibitors are allowed to enroll
Willingness to forego concurrent use of supplements containing omega-3 fatty acids, corticosteroids, non-steroidal anti-inflammatory drugs or other FAP directed drug therapy.
Use of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6 weeks.
Inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL <80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosing
Participants requiring daily use of non-steroidal anti-inflammatory drugs (NSAIDs), with the exception of =< 81 mg aspirin per day; during study participation, acetaminophen is preferred for treatment of pain; the use of NSAIDs, as needed for pain, is discouraged
Patients taking any of the following drugs are excluded: inducers or inhibitors of CYP2C9, warfarin, aspirin, corticosteroids, or non-steroidal anti-inflammatory drugs (NSAIDs)
Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
Subjects receiving heparin, warfarin, or other similar anticoagulants. Note: Subjects may be receiving lowdose aspirin and/or non-steroidal anti-inflammatory agents.
Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several days
Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial
Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs for > 2 weeks, and other platelet inhibitory agents, strong inhibitors/inducers of cytochrome P450-3A4 (CYP450-3A4)
Use of non-steroidal anti-inflammatory drugs and aspirin is allowed but must be tracked
Non-steroidal joint injection within the last 3 months
Requires treatment with non-steroidal anti-inflammatory agents that cannot be stopped for one week during study participation
Concomitant use of aspirin or non-steroidal anti-inflammatory drugs
Ongoing use of anticoagulant therapy other than aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) that cannot be stopped for surgical procedures
Contraindication to use of non-steroidal anti-inflammatory drug (NSAID), acetaminophen or IV opioids
No aspirin (ASA) or non-steroidal anti-inflammatory drugs (non-steroidal anti-inflammatory drugs [NSAIDS]) administration
Use of non-steroidal anti-inflammatory drugs and aspirin is allowed but must be tracked
Current or planned use of anticoagulants other than aspirin or non-steroidal anti-inflammatory agents
Patients who have taken non-steroidal anti-inflammatory drugs (NSAIDs) in the past two weeks
Use of any non-aspirin non-steroidal anti-inflammatory drug (NSAID) at any dose at least three times a week during the two months prior to randomization
Concomitant non-steroidal anti-inflammatory drug (NSAIDS) or other anticoagulant/antiplatelet therapy, including acetylsalicylic acid (Aspirin) (ASA) > 81mg/day
As iloprost inhibits platelet function, patients must not be taking anticoagulants, with the exception of aspirin or other non-steroidal anti-inflammatory medications
Participants must consent to refrain from using aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX)-inhibitors for the duration of the trial
Any acetaminophen, aspirin, non-steroidal anti-inflammatory drugs (NSAID), or statin use within 2 days of testing (known to affect mitochondrial function)
Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), non-steroidal anti-inflammatory drug (NSAID)s or NSAID-containing products
History of daily use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) in the week preceding study entry
Patient must not be taking non-steroidal anti-inflammatory drugs (NSAIDS), clopidogrel, dipyridamole, or aspirin therapy > 81 mg/day
Use of any aspirin-containing products or other non-steroidal anti-inflammatory drugs (NSAIDs) (>= 2 days per week on a regular basis)
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
Agree not to take a daily dosage of a non-steroidal anti-inflammatory drugs (NSAID) except 81 mg cardioprotective aspirin for the 6-week intervention period; (higher doses of an NSAID on an ‘as needed’ basis for acute pain management are permitted but should not exceed more than 1000 mg on any given day)
Anti-platelet agents: if currently receiving aspirin, ibuprofen or other non-steroidal anti-inflammatory or anti-platelet agents, not eligible