Receipt of any anticancer medication in the days prior to receiving the first dose of study medication
Able to understand and adhere to dietary and medication restrictions as recommended for the safe use of phenelzine
Patient with angina not well-controlled by medication;
Requirement for systemic immune suppressive medication
Anticoagulant medication of any kind; especially Ascal(and derivates), coumarines (Sintrom and Marcoumar), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)
New immunosuppressive medication or extracorporeal photochemotherapy (ECP) within days of starting treatment with abatacept
Participants must agree to discontinue all vitamin supplements while taking study medication and for thirty days past the last dose of study medication
Active pulmonary disease requiring medication to include multiple inhalers (> inhalers and one containing steroids)
Lithium medication
Known cardiac arrhythmias requiring medication.
History of hypertriglyceridemia or hypercholesterolemia and currently on medication(s)
Serum uric acid =< mg/dL (with or without medication control)
Prior medication:
Patient has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication.
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
No characteristics suggesting a potential higher risk of infection with intraprostatic injections:\r\n* Recurrent urinary tract infections or history of prostatitis within months prior to enrollment into the study\r\n* Urine analysis positive for nitrites and leucocyte esterase; such patients could be considered for the study after treatment and resolution of the infection\r\n* Active proctitis\r\n* History of prostatic abscess\r\n* Taking immunosuppressive medication including systemic corticosteroids\r\n* Active hematologic malignancy
Hypertension that is unstable or not controlled by medication.
Note: If a patient is on a strong CYPA inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
Study medication cannot be administered through gastric (G)-tube, unless additional information from the manufacturer becomes available in the future
Medication related exclusions
understand that the study medication may have teratogenic risk
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
For subjects with ATRT only, subject must have seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of days prior to the planned first dose of tazemetostat
Active pulmonary disease requiring medication to include multiple inhalers (> inhalers and one containing steroids)
Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
Patients who are on immunosuppressant medication
Patients on antipsychotic medication
Patients on antiplatelet/anticoagulant medication that cannot safely be discontinued - days prior to the procedure
Subjects with active herpes simplex or herpes zoster; subjects with a history of herpes zoster who have had an outbreak within the last year will also be excluded; subjects on prophylaxis for herpes who started taking medication at least days prior to study entry, should continue to take the prescribed medication for the duration of the study
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids, such as systemic cyclosporine and tacrilomus; consult principal investigator for questions, including necessary washout period for the specific drug
Currently on medication for diabetes or hypercholesterolemia
Received anti-viral treatment with activity against influenza (for example amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within weeks prior to randomization
Subjects of childbearing potential must consent to utilize a medically accepted means of contraception throughout the active dosing period with study medication and for a minimum of days following the administration of the last dose of study medication.
Are instructed to avoid pregnancy through days after the last dose of study medication.
Sodium >= LLN =< days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medication
Patient willing to complete a medication diary
Participants receiving the following medications or treatments within the weeks ( days) prior to consenting; these medication and treatments may not be re-started at any time throughout the study in order to be remain eligible:\r\n* Breast tumor resection surgery (reconstructive surgery permitted)\r\n* Chemotherapy\r\n* Radiation therapy\r\n* Allergy desensitization injections\r\n* Growth factors (Procrit, Aranesp, Neulasta)\r\n* Other agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)\r\n* Any investigational medication
Inability to inject medication or test for finger stick glucose
Patient must not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
agree to take a pregnancy test prior to starting study medication and throughout the study participation.
Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication are elgible for study after discussion and approval by the Medical Monitor.
Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator
Males must agree to take appropriate precautions to avoid fathering a child from screening until months after their last dose of study medication
Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
Co-medication that may interfere with study results, e.g., immuno-suppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the Investigator. Subjects should be on a stable dose of steroids for at least week prior to first dose of MRZ.)
Prior medication:
The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than % of the skin during the six months prior to study entry (iv) -fluorouracil or imiquimod; also, treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within days to starting study medication
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
Patients who have received antiandrogens such as flutamide (EULEXIN), bicalutamide (CASODEX), or nilutamide (NILANDRON) for > months must be off treatment for weeks and demonstrate a continued rise in PSA after withdrawal. Patients on antiandrogens for < months must be off medication for weeks. Patients on alpha reductase inhibitors such as finasteride (PROSCAR, PROPECIA), or dutasteride (AVODART) must stop medication at least months from study entry.
Patients receiving anti-herpes medication within week prior to initiating HF treatment.
Patients with malabsorption in the small intestine or other conditions that would preclude administration of oral medication
International Prostate Symptom Score (IPSS) < (and < if on medication for benign prostatic hypertrophy such as tamsulosin) at time of enrollment
Patients that have received the study medication (Xgeva/Prolia)
Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started taking medication at least days prior to study entry, and have no active signs of active infection, and whose last active infection was more than months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study.
Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
Patients receiving other investigational medication (including investigational immunotherapy for NSCLC) or having received such medication within days before entering the protocol
Hypertension must be well controlled on stable doses of medication for at least two weeks prior to enrollment
Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, ibuprofen, pentamidine)
A concurrent skin rash or skin condition requiring treatment with a prescription medication
Patient medication lists will be reviewed by a member of the study team for possible interactions with the nelfinavir; a patient may be deemed ineligible for the study if he/she is taking an essential medication that is known to interact with nelfinavir
Is taking systemic corticosteroids (more than consecutive days) or other immunomodulators or immune suppressive medication
Subjects who fail to comply with site requirements for cessation of medication that interfere or increase procedure risk.
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
Subjects on concurrent anticoagulant, or immunosuppressive medication
Subjects on anti-cancer medication whether biologic or pharmaceutical
Subjects on concurrent anticoagulant, or immunosuppressive medication
Subjects on anti-cancer medication whether biologic or pharmaceutical
Glycosylated hemoglobin is <=.% hyperglycemic participants permitted if glucose is well controlled by hypoglycemic medication).
Current users of potent inhibitors of tamoxifen metabolism must be able to discontinue their use and switch to an alternative medication for the duration of participation, under the advice of their physician; if the physician feels that an alternative medication is not appropriate for the subject and the current medication is medically necessary, the subject will not be eligible; the drugs are listed below; many of these are not in clinical use at the moment; bupropion, celecoxib, chlorpheniramine, chlorpromazine, cimetidine, citalopram, clemastine, clomipramine, clozapine, cocaine, delavirdine, desipramine, diphenhydramine, doxepin, duloxetine, escitalopram, fluoxetine, haloperidol, halofantrine, hydroxyzine, imipramine, isoniazid, ketoconazole, methadone, methimazole, mibefradil, miconazole, nicardipine, paroxetine, pergolide, perphenazine, pioglitazone, pyrimethamine, quinidine, quinine, ranitidine, ritonavir, ropinirole, sertraline, terbinafine, thioridazine, ticlopidine, tranylcypromine, trazodone, tripelennamine
Previous treatment with immunotherapy within weeks of starting study medication, chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER directed therapies) within weeks of starting study medication, or hormone therapy within weeks of starting study medication.
Treatment with psychotropic medication (psychostimulant, antidepressant, anxiolytic, antipsychotic) within the past two weeks, unless being prescribed specifically as an anti-emetic
Patient on stable analgesic regimen for > days without escalation during study period with rescue or immediate release medication every hours or longer
Treatment with any Food and Drug Administration (FDA) non-approved study medication within the past four weeks; off label treatment with FDA approved medication is allowed
As per self-report or review of the patients medical record, if the patient is taking anti-depressant medication, fewer than three months on the same dose of anti-depressant medication
Patients with epilepsy requiring permanent oral medication
Medication(s) known to affect body fluid balance
Inability to taste or smell due to medication or health condition
Patients with fasting serum triglycerides > and/or with hypertriglyceridemia requiring medication (but not patients with hypercholesterolemia: patients with hypercholesterolemia with or without medication are eligible).
Participants who are receiving any other investigational agents that might interact with study medication or influence the measurement of study outcomes
Participants who have recently started or changed doses of psychoactive medication which might affect psychological outcome measures in the judgment of the study PI; allowable time frames are medication-specific and will be determined by the study PI
Participants may not enroll in this study if they are receiving a study agent at the time of enrollment; a participant who chooses to enroll in a medication trial AFTER initial enrollment in our study will be allowed to stay in the study at the discretion of the study PI
PHASE II: If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study principal investigator (Pl)/co-PI or confirmed by reports in the medical record at MSKCC, by serf-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
Use of medication for treatment of another sleep disorder, such as restless leg syndrome or narcolepsy
Immune suppressive medication
Take medication for sleep (e.g., hypnotics and sedatives) every night; melatonin is permitted
Tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for >= weeks and ust not be expected to stop the medication during the study period
Willingness to discontinue smoking during the study two weeks prior to beginning the study and willingness to not smoke while taking study medication
Active pulmonary disease requiring medication to include multiple inhalers (> inhalers including one containing steroids)
Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigators opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids).
Be willing to forego other interventions in the treatment fields than the ones approved by the investigator that would interfere with the protocol or evaluation of the study medication
Co-medication that may interfere with study results; e.g., immune-suppressive agents other than corticosteroids
Able to read, understand, follow the study procedure and complete crofelemer, rescue medication, and bowel movement diaries
Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within days of study participation
Medication approval from their own physician
Unwillingness to prevent pregnancy during the medication phase and month afterwards (women only)
Participation in a study which involved medication within the last month
Use anti-diabetic medication (including insulin)
Participants with known inability to adequately absorb oral medication
Regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (i.e. regular use of non-steroidal anti-inflammatory medication, insulin therapy, steroid therapy, or antibiotics)
Active pulmonary disease requiring medication to include multiple inhalers
Participants must agree to discontinue all vitamin supplements while taking study medication and for thirty days past the last dose of study medication
Chronic medication use that cannot be safely stopped
Use of any other medication that could impact dietary intake, such as prednisone
Is receiving any medication prohibited in combination with study chemotherapies as described in the respective product labels, unless medication was stopped within days prior to randomization.