Have no symptoms of cranial hypertension or convulsions within days before Cycle Day (anti-epileptic drugs and corticoids are allowed to control any preexisting symptoms)
Have metastatic breast cancer with severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
Patients with clinical symptoms or signs of gastrointestinal obstruction
Non-escalating steroid requirement at the time of consent and study drug initiation for the treatment of CNS symptoms
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\r\n* There will be no exclusion of patients with known visual impairment or symptoms, including by not limited to peripheral flashes (photopsia), blurred or double vision, floaters, color distortion and dimness, difficulties with light/dark accommodation, tunnel vision or other field defects, halos, apparent movement of stationary objects, and complex disturbances; patients will have a baseline ophthalmologic exam to serve as a point of comparison and further exams as needed should visual symptoms develop; no pretreatment eye exam findings or ocular symptoms have been associated with an increased risk of ocular toxicity seen with AT
Lower urinary tract symptoms defined by International Prostate symptom score (IPSS) >
Symptomatic loco-regional disease that causes ongoing grade or grade urinary or rectal symptoms
Uncontrolled asthma (defined as having or more of the following features of partially controlled asthma within days prior to starting study treatment: Daytime symptoms more than twice per week, any limitation of activities, any nocturnal symptoms/awaking, need for reliever/rescue inhaler more than twice per week, or known lung function [peak expiratory flow (PEF) or forced expiratory volume in second (FEV)] without administration of a bronchodilator that is < % predicted or personal best [if known]).
Patients with microscopic hematuria (defined as > red blood cells [RBCs] on urinalysis) or worsening urinary symptoms within days prior to the initiation of study treatment.
Clinical symptoms (e.g., dyspnea or cough) consistent with BOS of ? months duration
Symptoms of urogenital atrophy including dyspareunia or vaginal dryness
Signs or symptoms of life-threatening raised intracranial pressure: as defined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding - day delay in scheduling neurosurgery
Asymptomatic off steroids for at least days except patients: a) who have mild symptoms from intracranial disease that do not affect their performance status; or b) who are asymptomatic, but require steroids for control of symptoms on a maximum dose of dexamethasone mg/day orally (PO) or equivalent
Patients must have minimal or no disease related-symptoms (minimal symptoms will include those that do not affect activities of daily living or pain that does not require regularly scheduled narcotics)
No evidence of clinical progression, in the form of increased lesions on cross-sectional imaging, or new cancer-attributable symptoms or worsening of existing symptoms
Patients may receive steroids to control symptoms related to central nervous system (CNS) involvement, but the dose must be =< mg per hours of dexamethasone (or the equivalent). Patients symptoms should experience stability of neurological symptoms for at least days, or on tapering dose of steroids. Physiologic replacement doses for adrenal insufficiency is allowed on this protocol
No clinical symptoms of hypothyroidism
Uncontrolled asthma (defined as having or more of the following features of partially controlled asthma within days prior to starting study treatment: daytime symptoms more than twice per week, any limitation of activities, any nocturnal symptoms/awaking, need for reliever/rescue inhaler more than twice per week, or known lung function [peak expiratory flow (PEF) or forced expiratory volume in second (FEV)] without administration of a bronchodilator that is < % predicted or personal best [if known])
Subjects with controlled brain metastasis (no radiographic progression at least weeks following radiation and/or surgical treatment, off steroids for at least weeks, and have no new or progressing neurological signs or symptoms) will be allowed
Subjects with brain metastases are eligible if treated (whole brain radiotherapy, stereotaxic radiotherapy, surgery) and have no symptoms (except for signs and symptoms related to central nervous system therapy) for at least weeks before initiation of allocated treatment and are not taking any forbidden medications.
Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
Signs or symptoms of gastrointestinal obstruction
Current signs or symptoms of heart failure (HF) or ischemia
Biliary obstructive symptoms or signs
Symptoms/signs suggestive of influenza like illness (ILI)
Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia
Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
- Non-tolerable > Grade neuropathy or evidence of unstable neurological symptoms within weeks first dose
Must have indication for treatment (adapted from National Comprehensive Cancer Network [NCCN] guidelines)\r\n* Any of the following constitute an indication for treatment:\r\n** Significant symptoms due to any iBCL: Which may include pain/discomfort, limitation of function, fatigue/malaise/constitutional symptoms, B-symptoms (fever, weight loss, night sweats), pruritus\r\n** Threatened end-organ function due to any iBCL\r\n** Progressive cytopenia secondary to any iBCL\r\n** Steady progression of follicular lymphoma (FL) and marginal zone lymphoma (MZL)
Patients must not have experienced radiographic disease progression or clinical signs of symptoms of instability requiring urgent intervention.
Prophylactic anti-infective therapy, which is given without clinical symptoms is allowed.
Signs and symptoms of active dental disease
Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papaedema).
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Signs or symptoms of systemic systemic infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection
Symptoms of uncontrolled intracranial pressure
Patients should have a performance status (Karnofsky score) of > out of , i.e. can carry on normal activity with effort while showing some signs or symptoms of disease
Patients with minimal or no disease related-symptoms (minimal symptoms will include those that do not affect activities of daily living or pain that does not require regularly scheduled narcotics)
Newly diagnosed patients may need to be on steroids due to surgery or control of neurologic symptoms; patients on steroids postoperatively or for control of tumor-related edema are eligible, but attempts to keep patients on the lowest dose necessary to control symptoms should be made
Cohort A (asymptomatic): Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy within days prior to first treatment. Cohort B (symptomatic): Subjects with neurologic signs and symptoms related to metastatic brain lesions are eligible per Amendment . Subjects with neurologic signs and symptoms may be treated with a total daily dose of no more than mg of dexamethasone that is stable or tapering for days prior to first treatment. Subjects with neurologic signs and symptoms who are not being treated with steroids are eligible for Cohort B and should have no experience of seizure within days prior to first treatment.
Active symptoms of MF as demonstrated by a symptom score of at least points (on a to scale) on at least one of the symptoms or a score of or greater on at least of the symptoms
Patients with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including those used to control symptoms, within month of first dose
Associated with symptoms and/or findings; OR
Active signs or symptoms of CNS involvement by malignancy
Associated with symptoms and/or findings; OR
Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs:
Non-malignant neurological disease that would interfere with evaluation of symptoms or signs of brain metastases
Complete supportive and palliative care will continue to be provided to ameliorate signs and symptoms that were pre-existing or may arise while on study and which do not interfere with the objectives of the study
Presence of or more of the following PNH-related signs or symptoms within months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (hemoglobin < g/dL), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of pRBC transfusion due to PNH.
Tumor involvement of the following sites or any of these signs or symptoms likely to be associated with Tb cancer:
Signs or symptoms of systemic bacterial infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection).
Previous significant urinary obstructive symptoms
Significant obstructive symptoms (IPSS greater than )
Known significant or active coronary artery disease (CAD) or peripheral vascular disease (PVD) or cardiovascular disease (CVD) defined as abnormal stress test, symptoms, or requiring medication for the prevention of symptoms
Deteriorating neurological symptoms, or need for increasing doses of corticosteroids or new onset of seizures between the screening assessment and cycle day
Signs or symptoms of infection within weeks prior to cycle , day ; abnormal urinalysis does not constitute signs/symptoms of infection unless urine culture obtained at screening grows >= , colonies of bacteria; patients with an ileal conduit and a urinalysis and/or culture that are abnormal are eligible unless they have peripheral blood white blood cell (WBC) > ULN, fever, or other symptoms suggestive of a urinary tract infection
Acquired immunodeficiency syndrome (AIDS) related syndromes or symptoms that may pose an excessive risk for transplantation-related morbidity as determined by the Treatment Review Committee (see Appendix D).
Progressive metastatic disease defined by one of the following, occurring within months of study entry:\r\n* At least a % increase in radiologically or clinically measurable disease\r\n* Appearance of any new lesion\r\n* Symptomatic disease (including worsening hormonal symptoms or symptoms related to tumor burden)
Subjects who have significant urinary obstructive symptoms; American Urological Association (AUA) score must be =< (alpha blockers allowed)
Patient has known human immunodeficiency virus (HIV) or hepatitis B or C infection, as such patients may be at increased risk for toxicity due to concomitant treatment, and disease-related symptoms may preclude accurate assessment of the safety of PBI .
Subjects with signs or symptoms of other major diseases including, but not limited to: end organ failure, major chronic illnesses other than cancer, coagulation disorders, hemolytic conditions (eg, sickle cell disease ) or active infections that, in the opinion of the investigator, make it undesirable for the subject to participate in the study.
Symptoms or signs of active brain metastases;
Subjects with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including those used to control symptoms, within months of first dose. Subjects with glioma who are on a stable, steroid dosing regimen days prior to the screening MRI may be permitted to enroll with Medical Monitor approval.
Carcinoid with hormone related symptoms
No signs or symptoms of CNS metastases (mets) within the last days (from enrollment evaluation)
Patients with any signs/symptoms of interstitial pneumonia
Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
Hypersensitivity to cyclooxygenase- inhibitors, sulfonamides, NSAIDs, or salicylates; NSAID associated symptoms of gastritis.
Require radiation therapy for palliation of symptoms or to prevent local progression of disease and associated complications and/or symptoms from metastases
Chronic systemic corticosteroids (unless required for treating treatment emergent AEs or required for management of signs or symptoms due to brain metastases, upon discussion with Bristol-Myers Squibb [BMS] medical monitor)
The patient must currently have at least one of the following:\r\n* Uncontrolled symptoms, defined as any of the following:\r\n** Headaches associated with mass effect\r\n** Uncontrolled seizures despite different antiepileptic drug regimens (i.e., antiepileptic drugs tested either sequentially or in combination)\r\n** Focal neurological symptoms\r\n** Cognitive symptoms or deficits OR\r\n* Tumor progression by serial magnetic resonance imaging (MRIs), defined as any of the following:\r\n** New or progressive enhancement\r\n** New or progressive T or fluid attenuated inversion recovery (FLAIR) signal abnormality OR\r\n* Age >= years\r\n** NOTE: Patients aged less than whose only symptom of low-grade glioma is seizures that are well-controlled on antiepileptic drugs, and who have no evidence of radiographic progression, are ineligible
Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)
Subjects with signs and symptoms of chronic GVHD.
Active symptomatic MF as defined by the screening MPN-SAD patient-reported instrument requiring a severity score of at least on one symptom, or a severity score of ? on at least two of the symptoms (on a to scale).
Signs or symptoms of progressive or uncontrolled liver disease
Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study.
No known or suspected (associated neurological signs and symptoms) brain metastases (including leptomeningeal involvement)
No seizures, focal weakness of any extremity (by neurologic exam), or stroke symptoms in the past month
Subjects with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including to control symptoms, within months of first dose. Subjects with glioma who are on a stable, steroid-dosing regimen prior to screening MRI may be permitted to enroll with Medical Monitor approval
Participants with stable enhancement/edema are eligible if they require corticosteroids to control symptoms
An individual with an adrenal neoplasm less than cm in size with biochemically confirmed evidence of hypercortisolism ( out of : dexamethasone suppression test [DST] > mcg/dL, elevated urine free cortisol, and/or morning adrenocorticotropic hormone [ACTH] < . pmol/l) without overt clinical signs and symptoms
Medical history of Heart Failure (HF) with at least prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that required/requires treatment with a diuretic for improvement,
Vital signs criteria defined as or more of the following at Baseline:
Onset of influenza symptoms within days prior to study enrolment. Symptoms may include cough, dyspnea, sore throat, feverishness, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea and vomiting.
Clinical symptoms of influenza with positive influenza diagnostic test result or strong suspicion of influenza illness based on clinical symptoms and local surveillance information.
Subjects who have taken more than a total of days ( doses) of approved anti-influenza therapy in the period from onset of symptoms and prior to enrolment.
One or more of the following lymphoma-related symptoms:
Night sweats without signs of infection
presence of at least one of the following B-symptoms:
Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy)
Symptoms suggestive of influenza-like illness
Somatostatin analogs can be continued at their tolerated dose in patients with functional symptoms related to underlying disease such as in functional islet cell, insulinomas, glucagonomas etc
Patients with clinical symptoms consistent with active gastritis
Previous use of light therapy to alleviate fatigue or depressive symptoms
Active B symptoms
Experience ? concurrent symptoms (fatigue, sleep disruption, depressive symptoms, and/or cognitive dysfunction as measured by screening instruments)
Previous use of light therapy to alleviate fatigue or depressive symptoms
Clinical asthma (variable and recurrent symptoms of airflow obstruction and airway hyper-responsiveness)
Subjects who exhibit signs of an infection at screening will be rescheduled when symptoms have resolved
Experiencing or more of the following symptoms felt to be associated (per the patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety (worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing, memory loss), depression, existential/spiritual distress (hopelessness, lack of meaning in life, lack of peace), fatigue, pain, and sexual dysfunction; these symptoms may be new or worsened since cancer diagnosis; both symptoms from this list must have been present one week prior to eligibility assessment
Uncontrolled arrhythmias causing symptoms or hemodynamic compromise in the last week
Has gastrointestinal symptoms with severity score of =< out of visual analog scale for irritable bowel syndrome (VAS-IBS) in at least out of items measured
Currently receiving any type of formal counseling for depressive symptoms (allowing caregivers who receive outside counseling for depressive symptoms could contaminate treatment groups)
Persistent genitourinary symptoms causing discomfort for more than weeks prior to the visit with the physician
Tried at least prior pharmacological/non-pharmacological treatment for their genitourinary symptoms
Patients with symptoms and signs of clinically unacceptable deterioration of primary disease at time of screening
Report all three symptoms as present in the past week with worst severity rating >= (- scale) for at least two of the three symptoms
Subject reported symptoms of vaginal infection with significant vaginal discharge or odor
Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms
Patients will be free of signs and symptoms of infection at the time of entering the study and, most importantly, will be encouraged to have sufficient donors to administer prophylactic white cell transfusion twice a week for six weeks in order to assess their effectiveness
Women over the age of who are postmenopausal and wish to avoid hormonal therapy to treat menopausal symptoms
Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple discharge, eczema of the nipple
Individuals that have a personal or family history of CRC (previous adenomatous polyp), and/or, have a signs and symptoms colonoscopy order from their primary care physician
Subjects who, at screening, have abnormal vital signs and/or physical exam, including a temperature >= . C, systolic blood pressure =< or > mmHg, pulse =< or > beats per minute, new rash, signs of infection
Patients without cGVHD are defined as having no signs or symptoms of GVHD with chronic features diagnosed at any time prior to enrollment
Subjects with any evidence of respiratory infection including any signs or symptoms of either a lower respiratory infection (LRI) or upper respiratory infection (URI)
Persistent or worsening disease-related symptoms, including but not limited to fatigue, pruritus, night sweats, early satiety, and other symptoms as determined by a MPN-SAF TSS score of > points; AND
Signs and symptoms of localized catheter-related infection (tenderness and/or pain, erythema, swelling, purulent exudates within cm of entry site)
With signs and/or symptoms of central nervous system cancers (e.g., tumors, metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period
Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to taxane-based therapy
Respiratory failures marked by signs and symptoms of carbon dioxide (CO) retention or hypoxemia
Exhibiting HF symptoms (e.g. shortness of breath, edema)
Symptoms of dysphagia