Severe and/or symptomatic refractory concurrent infection other than EBV
Patients with septicemia or severe infection
Patients with septicemia or severe infection
Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy
Current severe, uncontrolled systemic disease other than cancer
Current severe, uncontrolled systemic disease
Severe valvular heart disease
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration)
Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
Severe comorbidities:
Severe comorbidities:
Severe medical comorbidities precluding endoscopy
Patients with known G6PD deficiency, severe psoriasis, porphyria, macular degeneration or severe diabetic retinopathy are ineligible because of the potential for greater HCQ toxicity
Severe hip disease precluding the use of dorsolithotomy position
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, septicemia, or methicillin resistant staphylococcus aureus infection
Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
Severe, uncontrolled systemic disease at screening;
Severe active co-morbidity as determined by the investigator or principal investigator
Patients with severe intolerance to glucocorticoids
Patients with severe allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin; severe reactions include anaphylaxis and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)
History of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for > 2 days; this exclusion relates to the long-term possibility of severe cutaneous or mucocutaneous reactions to rituximab that might occur at increased frequency in participants who have had severe skin disease or reactions in the past
Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal [GI] tract ulceration)
GROUP 6: Progressive gastrointestinal disease as defined by all of the following items:\r\n* Disease duration of scleroderma =< 2 years.\r\n* Documented severe malabsorption syndrome requiring nutritional support; severe malabsorption syndrome is > 10% weight loss and on total parenteral nutrition (TPN) or enteral feedings\r\n* High score on distention/ bloating scale (>= 1.60 out of 3.00) on gastrointestinal (GI) questionnaire
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, septicemia, or methicillin resistant Staphylococcus aureus infection
Severe or uncontrolled concurrent disease, infection or comorbidity.
Severe, active co-morbidity, defined as follows:
Current severe or uncontrolled systemic disease
Evidence of severe concurrent disease requiring treatment
Current severe, uncontrolled systemic disease
Severe, active co-morbidity, defined as follows:
Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery)
Severe/uncontrolled concurrent illness/infection
Patients in Part E or Part F: history of severe immune-mediated adverse reactions or severe hypersensitivity to pembrolizumab
Other concurrent severe and/or uncontrolled medical, psychiatric or social conditions that could compromise the safety or compliance of treatment as so judged by treating physician\r\n* Examples include but are not limited to:\r\n** History of severely impaired lung function defined as spirometry and diffusion capacity of carbon monoxide (DLCO) that is =< 50% of the normal predicted value and/or 02 saturation that is =< 88% at rest on room air\r\n** Uncontrolled diabetes mellitus consistent fasting blood glucose readings > 160 mg/dL or < 50 mg/dL); use of diabetic medications is permitted\r\n** Hyperlipidemia (total cholesterol > 300-400; triglycerides > 300); use of lipid lower lowering agents is permitted\r\n** Other: e.g. severe infection, severe malnutrition, ventricular arrhythmias, known active vasculitis of any cause, tumor invasion of any major blood vessel, severe chronic liver or renal disease, active upper GI tract ulceration
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia that require IV antibiotics within 2 weeks of starting study treatment
The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).
Severe, active co-morbidity
Concurrent severe or uncontrolled medical disease.
Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
Concurrent severe or uncontrolled medical disease.
Severe organ failures or diseases, including: clinically relevant coronary disease, myocardial infarction or any other relevant cardiovascular disorder within 12 months before study entry, severe psychiatric illness and severe infection.
Severe liver disease
Severe liver disease
Evidence of severe concurrent disease requiring treatment.
Active uncontrolled infection or severe infection disease (e.g., severe pneumonia, meningitis, septicemia, or methicillin resistant Staphylococcus aureus infection)
Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral/enteral medication.
Severe uncontrolled malabsorption condition or disease (i.e. grade II/III diarrhea, severe malnutrition, short gut syndrome)
History of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for > 2 days; this exclusion relates to the long-term possibility of severe cutaneous or mucocutaneous reactions to rituximab that might occur at increased frequency in participants who have had severe skin disease or reactions in the past
Concomitant severe or uncontrolled medical disease
Current severe, uncontrolled systemic disease
Severe or uncontrolled concurrent disease, infection or co-morbidity.
Patients with severe, active co-morbidity, defined as follows:
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
Severe, active co-morbidity
Severe, active co-morbidity, defined as follows:
Severe underlying chronic illness or disease
Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease
Other concurrent severe and/or uncontrolled medical disease, psychiatric illness, or social situation, which could compromise safety of treatment as so judged by the treating physician; Note: this includes but is not limited to: severely impaired lung function, uncontrolled diabetes (history of consistent blood glucose readings above 300 mg/dL or less than 50 mg/dL), severe\r\ninfection, severe malnutrition, ventricular arrhythmias, known active vasculitis of any cause, tumor invasion of any major blood vessel, chronic liver or renal disease, and active upper GI tract ulceration
The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease)
Severe, uncontrolled systemic disease
Other concurrent severe and/or uncontrolled medical disease, which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal [GI] tract ulceration, congestive heart failure, etc.)
Severe or uncontrolled medical issues
Current severe, uncontrolled systemic disease
Severe systemic diseases or active uncontrolled illnesses.
Severe active viral infection, especially hepatitis B; severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of randomization; contact the national co-investigator for further advice if necessary
Evidence of severe or uncontrolled systemic disease or HIV infection
Severe and uncontrolled disease, including:
Any other concurrent severe known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition including congestive heart failure grade III or IV according to the NYHA classification or with ejection fraction < 50%, etc.
Patients with severe and/or uncontrolled medial disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection [persistent fever and worsening clinical condition])
Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease
History of severe side effects toimmunotherapy
Severe illness requiring hospitalization
Severe, active co-morbidity: (e.g. cardiac disease; respiratory disease; chronic hepatitis; hemtological and bone marrow diseases; severe malabsoprtion; human immunodeficiency virus).
Severe psoriasis
Patients with severe hematologic, neurologic, or other uncontrolled disease
Severe, active co-morbidity (e.g. cardiac disease; respiratory disease; chronic hepatitis; hematological and bone marrow diseases; severe malabsorption)
Subjects with severe hemorrhage, or history of severe hemorrhage
Current severe, uncontrolled systemic disease
Open fractures with severe contamination.
Active uncontrolled infection or severe infectious disease, such as pneumonia, meningitis, septicemia, or methicillin-resistant Staphylococcus aureus infection.
Known severe ulcer disease
Current severe, uncontrolled systemic disease
Severe conduction disturbance
Active uncontrolled infection or severe infectious disease
Active uncontrolled infection or severe infectious disease
Severe or uncontrolled systemic infection
Severe conduction disturbances
Subjects with psoriasis or other severe skin disease (eg, autoimmune skin disease, active erythematous skin lesions, etc.)
Patients with severe medical or psychiatric diseases are INELIGIBLE (patients with stable chronic diseases such as high cholesterol or hypertension ARE eligible); examples of problems that would make patients INELIGIBLE include severe heart failure, or hypoxia due to severe lung disease
Concomitant severe or uncontrolled medical disease
Severe concurrent disease;
History of severe cardiac disease.
Concurrent severe uncontrolled illness not related to cancer
Current severe, uncontrolled systemic disease
Current severe, uncontrolled systemic disease
liver, pancreatic or severe renal disease unrelated to disease under study
Subject has severe granulocytopenia
Uncontrolled, severe infective processes
Current severe, uncontrolled systemic disease
Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver surgery
Patients with history of severe liver disease, defined as and confirmed by albumin less than 3.
Presence of severe cardiac disease
Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
Severe or symptomatic heart disease
Severe or untreated psychiatric disease
Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
Severe co-existing morbidities having a life expectancy of less than 30 days
Severe concurrent illness other than neoplasia
Severe depression as determined by the investigator
Within 48 hours of receiving either metronidazole for mild-moderate disease or vancomycin for severe uncomplicated disease
Severe cardiac disease
Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery)
Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver or pancreatic surgery
Patients with known severe esophagitis
Severe osteoporosis
History of severe food intolerance to broccoli
Recent or severe mental illness (uncontrolled severe depression or mood symptoms, active hallucinations, or hospitalization in the past month for a psychiatric condition); night and/or ‘swing’ shift work (which complicates EMA schedules);
Concurrent severe and/or uncontrolled medical condition (e.g., severe COPD).
severe cachexia
severe respiratory insufficiency or hypoxia
Severe acute illness
Participants who have any contraindication to iodinated contrast for routine computed tomography (CT) scans including: sickle cell disease, pheochromocystosis, multiple myeloma, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, or severe cardiomyopathy
Severe allergic disease
Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
Severe cardiac disease
Severe respiratory disease
Severe underlying chronic illness or disease (other than breast cancer)
Inability to participate in physical activity because of severe disability (e.g., severe arthritic conditions)
Active, uncontrolled infection or severe infectious disease.
Current severe, uncontrolled systemic disease
Severe, active co-morbidity, defined as follows:
Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
Visceral crisis or lymphangitic spread\r\n* NOTE: Visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease
EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Life-threatening visceral disease or other severe concurrent disease
EXCLUSION CRITERIA FOR THIRD-LINE THERAPY: Life-threatening visceral disease or other severe concurrent disease
Visceral crisis or impending visceral crisis at time of screening
Subjects with bulky visceral disease defined as > 4 cm
Symptomatic or rapid visceral progression
Patients with active visceral, central nervous system, or any bone metastases melanoma (stage IVM1b or IVM1c)
Life-threatening visceral disease or other severe concurrent disease
Evidence of visceral metastasis to the liver.
have impending visceral crisis that requires chemotherapy;
Patients who have any liver metastases or visceral metastasis of ? 3 cm, plus evidence of progression meeting irRC 1.0 within 1 month before the first OBP-301 administration.
Patients who have noncanonical DNA repair defects and extensive visceral disease or symptomatic bone disease requiring urgent tumor response
Identified as having visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis; visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
Requires urgent treatment with cytotoxic chemotherapy or other therapy is indicated (e.g., symptomatic visceral metastases)
Patients with parahepatic extension of disease with direct non-liver visceral involvement
No visceral crisis: Visceral crisis is moderate-to severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease
Development of visceral crisis since pre-registration.\r\n* NOTE: Visceral crisis is moderate-to-severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease.
Patients with definite liver metastasis > 1 cm or signs of visceral crisis or impending visceral crisis at the clinical discretion of the treating physician
Subjects with retroperitoneal and visceral sarcoma
Visceral crisis or rapidly progressive disease for which chemotherapy would be indicated
Symptomatic visceral KS (except for non-ulcerating disease restricted to the oral cavity)
Life-threatening visceral disease or other severe concurrent disease
Symptomatic liver or visceral organ metastasis
Life-threatening visceral disease or other severe concurrent disease
Evidence of liver metastases or visceral disease
Life-threatening visceral disease or other severe concurrent disease
Life-threatening, visceral metastases
Visceral metastases (e.g. lung, liver, brain, kidney, spleen)
Patients must be classified as having intermediate or poor-risk germ cell tumor, as follows:\r\n* Intermediate-risk (modified*)\r\n** Testis or retroperitoneal primary non-seminomatous germ cell tumors (NSGCT) with lymph node and/or lung metastasis but without non-pulmonary visceral metastasis AND any of the following pretreatment serum tumor marker (STM) values:\r\n*** Lactate dehydrogenase (LDH) from 3 to < 10 x upper limit of normal (ULN) (*this differs from the original International Germ Cell Cancer Collaborative Group [IGCCCG] criteria which includes patients with LDH from 1.5 to 10 x ULN)\r\n*** Serum human chorionic gonadotrophin (HCG) from 5,000 to < 50,000 MIU/mL\r\n*** Serum alpha-fetoprotein (AFP) from 1,000 to < 10,000 ng/mL\r\n** Seminoma histology regardless the primary site or serum tumor markers with any non-pulmonary visceral metastasis (liver, bone, brain, etc)\r\n* Poor-risk (any of the following):\r\n** Testis or retroperitoneal NSGCT primary with non-pulmonary visceral metastasis (liver, bone, brain, etc) regardless the STM values\r\n** Mediastinal NSGCT primary site of disease regardless the presence/absence of visceral metastasis or STM values\r\n** Testis or retroperitoneal NSGCT primary without non-pulmonary visceral metastasis but with poor-risk STM values:\r\n*** LDH >= 10 x ULN\r\n*** HCG >= 50,000 MIU/mL\r\n*** AFP >= 10,000 ng/mL
Visceral metastasis (excluding liver metastases) and/or lymphadenopathy
Presence of skeletal, and/or soft-tissue/visceral/nodal metastasis
have visceral crisis
No current evidence of visceral crisis or lymphangitic spread
No visceral crisis, lymphangitic spread or known brain metastases: visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease
Patients with immediately life-threatening visceral disease, for whom chemotherapy is the preferred treatment option.
Visceral (ie, liver or lung) metastases as only sites of metastases
Contraindications to angiography and selective visceral catheterization
Presence of unstable systemic disease (e.g., visceral crisis or rapid progression) in the judgment of the investigator
Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
Pending visceral crisis, in the opinion of the treating investigator
Visceral (eg, lung, liver) metastatic disease. Adenopathy is allowed;
Has rapid progression of visceral disease and, thus is a candidate for docetaxel; this determination will be at the discretion of the treating physician
A visceral metastasis greater than 8 cm
A visceral metastasis that due to its location cannot be safely treated with SABR
Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
History of visceral metastasis, or visceral metastases
History of visceral metastasis, or visceral metastases
COHORT B: Visceral metastatic disease
Patients experiencing a visceral crisis including severe organ dysfunction as assessed by > grade (Gr) 2 symptomatic toxicities, laboratory studies, and/or rapid progression of disease originating from visceral metastasis
Symptomatic liver or visceral organ metastasis
Contraindications to angiography and selective visceral arterial catheterization
Patients with rapidly progressive or extensive symptomatic visceral metastatic disease
Pending visceral crisis, in the opinion of the treating investigator
Life-threatening visceral disease or other severe concurrent disease
Life-threatening visceral disease or other severe concurrent disease
Patients who require or may be expected to require urgent treatment with docetaxel during the study (e.g., patients with visceral metastases).
Presence of >= 1 metastatic site (nodal, visceral) that is amenable to core biopsy
Contraindications to angiography or selective visceral catheterization
Life-threatening visceral disease or other severe concurrent disease
Patients with visceral disease are ineligible
Patients in whom urgent treatment with docetaxel is indicated, per clinician discretion; this includes, but is not limited to patients with symptomatic visceral metastatic disease
Patients with paraspinal extension of disease with visceral involvement
Presence or history of visceral melanoma metastasis
Eligible for taxane monotherapy, as per local investigator assessment (e.g., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control which may require combination chemotherapy)
Life-threatening, visceral metastases
Cohort A: Patients must have at least one measurable visceral lesion (per RECIST 1.1); a visceral lesion is any solid organ except for skin, lymph node, and musculoskeletal tissue; at least one of these visceral lesions must be measurable per RECIST 1.1
Cohort B: Patients must not have any visceral lesions
Patients with immediately life-threatening visceral disease for whom chemotherapy is preferred treatment option.
Patients with metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
AIM 3: Patients with either cutaneous, visceral or brain melanoma metastases
Visceral (e.g. lung, liver) metastases
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an active or uncontrolled infection are not eligible
Subjects who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible.
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Infection: Patients who have an uncontrolled infection are not eligible
Patients that have an active, uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled serious infection are NOT eligible for either Stratum
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Subjects who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible.
Patients with active, uncontrolled infection are not eligible for this study
Subjects who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients with any active, uncontrolled infection are NOT eligible for participation
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled or untreated infection are not eligible
Patients who have an uncontrolled infection are not eligible
Infection: patients with documented uncontrolled infection at the time of study entry are not eligible
Infection: Subjects with uncontrolled infection not eligible
Active uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are not excluded
Subject has an uncontrolled active infection requiring treatment and fever 38.3°C or higher 48 hours before the first dose of study drug. Controlled infections (i.e. 3 negative cultures completing antibiotics and/or stable fungal infection in therapy) are allowed provided the subject has a temperature of < 38.3°C within 48 hours of the first dose of study drug.
Uncontrolled intercurrent active infection; controlled infection on long term suppressive or maintenance therapy is permissible
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics
=< 14 days before first dose of protocol-indicated treatment:\r\n* Anti-cancer therapy with an approved or investigational agent (including chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or biological therapy).\r\n* Radiosurgery or radiotherapy. (Note: A tumor lesion situated in a previously irradiated area is considered a measurable/target lesion only if subsequent disease progression has been documented in the lesion.)\r\n* Initiation of a new erythropoietin, darbepoietin, and/or bisphosphonate therapy.\r\n* Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery.)\r\n* Serious or uncontrolled infection.\r\n* Infection requiring parenteral antibiotics. (Note: Patients with a non-serious infection under active treatment and controlled with oral antibiotics initiated at least 10 days prior to initiation of protocol-indicated treatment are not excluded – e.g. urinary tract infection controlled with oral antibiotics.)\r\n* Unexplained fever > 38.0 degree Celsius (C).
Uncontrolled active infection or uncontrolled invasive fungal infection (positive blood or tissue culture). An infection controlled with an approved or closely monitored antibiotic/antifungal treatment is allowed
Within 14 days before first dose of protocol-indicated treatment:\r\n* Active uncontrolled infection; patients with infection under active treatment and controlled with antibiotics initiated at least 14 days prior to initiation of protocol-indicated treatment are not excluded (e.g. urinary tract infection controlled with antibiotics)
Patients with active infection will not be eligible, but may become eligible once infection has resolved and at least 7 days have relapsed after antibiotics use was completed
Active, uncontrolled infection; patients with infection controlled with antibiotics are eligible
Uncontrolled infections; patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiologic, clinical and/or culture) that the infection is well controlled
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Serious active infection not controlled by antibiotics
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
Subject has an uncontrolled active infection requiring treatment and fever 38.3°C or higher 48 hours before the first dose of study drug. Controlled infections (i.e. 3 negative cultures completing antibiotics and/or stable fungal infection in therapy are allowed provided the subject has a temperature of <38.3°C within 48 hours of the first dose of study drug
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Any active infection not controlled by antibiotics
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).
Presence of active infection within 72 hours of treatment; patients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medications
Serious, active infections must be controlled; patients may be enrolled while still on antibiotics as long as clinical signs of active infection are absent
No uncontrolled infection; protocol principal investigator (PI) or designee will be final arbiter if there is uncertainty regarding whether a previous infection is controlled on appropriate (antibiotic) therapy
Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics
Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled
Serious, active infections must be controlled; patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved
Infection not controlled by antibiotics
Patients with multiple CMV, EBV or adenovirus infections are eligible given that each infection is persistent despite standard therapy as defined above; patients with multiple infections with one persistent infection and one controlled infection are eligible to enroll
Active infection not controlled with appropriate antimicrobial therapy
Infection not controlled by antibiotics
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Active infection not controlled with appropriate antimicrobial therapy
Active infection not controlled with appropriate antimicrobial therapy
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Infection: Patients who have an uncontrolled infection are not eligible until the infection is judged to be well controlled.
Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
Infection is a common feature of AML; patients with active infection are permitted to enroll provided that the infection is controlled; patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control
Known active infection requiring antibiotics within 7 days of initiation of study treatment, unless considered controlled in the opinion of the investigator
Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life threatening disease. If there is a history of prior malignancies or life threatening diseases, the patient must be disease free for at least 5 years.
Subjects must not have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology.
Other serious or life-threatening conditions deemed unacceptable by the principal investigator
History of life threatening or recurrent thrombosis/embolism; patients may participate if they are on anticoagulation during the treatment
Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
Uncontrolled active life-threatening infection.
Known intolerance to or life threatening side effects resulting from prior checkpoint inhibitor therapy
Active life-threatening infection
Patient has malignancy or life-threatening systemic disease or a history of advanced, serious, life-threatening malignancy/disease within the last 5 years, except very low-risk prostate cancer
Active life-threatening infection
Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeon
Active life-threatening infection
Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate
Has an uncontrolled, life-threatening active infection
No clinical evidence of life-threatening infection
Patients with untreated or uncontrolled life-threatening infection
Active life-threatening infection
Patients must not have untreated or uncontrolled life-threatening infection
No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy
Active life-threatening infection
Unstable or life-threatening arrhythmia
Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion.
Active life-threatening infection
Significant extrahepatic disease representing an imminent life-threatening outcome
Active life-threatening cancer requiring treatment other than ALL
MATCHED RELATED DONOR: No history of life-threatening opportunistic infection
HAPLOIDENTICAL RELATED DONOR: No history of life-threatening opportunistic infection
Active life-threatening infection
No life- or organ-threatening manifestations of MCD
Active life-threatening infection
Severe life, threatening infection
Severe life, threatening infection
Significant extrahepatic disease representing an imminent life-threatening outcome
HAPLOIDENTICAL RELATED DONOR: No history of life-threatening opportunistic infections
Active life-threatening infection
Significant extrahepatic disease representing an imminent life-threatening outcome
Significant extrahepatic disease representing an imminent life threatening outcome
Patients with an uncontrolled life-threatening infection
Patients with life-threatening condition or complication other than their basic condition
Known life-threatening systemic disease
Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less (eg, moribund or with shock unresponsive to fluid replacement)
Other life-threatening illness that is expected to impact life expectancy within 3 years
Unstable or life-threatening arrhythmia
Presence of any life-threatening co-morbidity
Presence of any life-threatening co-morbidity
Active life-threatening infection
Immediately life-threatening, severe complications of leukemia.
Patients must not have untreated or uncontrolled life-threatening infection
Participants must not have life-threatening co-morbidities
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
Active life-threatening infection
Any subject who has a life-threatening condition that requires high-dose immunosuppressant(s)
Other serious or life-threatening conditions deemed unacceptable by the principal investigator
Patients must not have untreated or uncontrolled life-threatening infection
History of life threatening or recurrent thrombosis/embolism; subjects may participate if they are adequately anticoagulated during the treatment
No untreated or uncontrolled life-threatening infection
Severe or life-threatening infection within 2 weeks of entry onto the study
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
Patients with an uncontrolled life-threatening infection
Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less.
Uncontrolled life-threatening infections
Any life-threatening condition that could affect protocol compliance.
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
Subject has an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
are eligible for any standard therapy known to be life prolonging or life saving
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
Evidence of life-threatening or fulminant CDAD.
Patients must have had no prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per low- or intermediate-risk neuroblastoma therapy (P9641, A3961, ANBL0531) prior to determination of MYCN amplification and histology
Known severe or life-threatening allergy or intolerance to ATG or cyclosporine/ tacrolimus
History of life threatening or recurrent thrombosis/embolism; patients may participate if they are on anticoagulation during the treatment
Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion
Subjects must be free of life-threatening illness (e.g., cancer) that would severely limit participation; those with chronic illnesses (e.g., asthma, diabetes) may participate with the permission of their physician
Have current or a history of ventricular or life-threatening arrhythmias or diagnosis
Current metabolic or life-threatening disease
Untreatable life-threatening arrhythmias
Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:
Acute life threatening infection
Patients must not be at short term risk for life threatening complications (such as airway compromise or bleeding from locoregional or metastatic disease,).
Patients with advanced/metastatic disease who have symptomatic visceral spread, and who have life threatening complications needing immediate therapy, such as massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver replacement with tumor.
Patients with advanced/metastatic, symptomatic, visceral spread, at risk of life-threatening complications in the short term by investigator assessment
Advanced/metastatic, symptomatic, visceral spread, with a risk of life-threatening complications in the short term.
Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
Subjects with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term including subjects with massive uncontrolled effusions, pulmonary lymphangitis, and over 50% of liver involvement in metastases.
Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)
Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life-threatening complications in the short term
Disease that is considered by the investigator to be rapidly progressing or life threatening such as extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumour (subjects who are intended for urgent chemotherapy)
Life-threatening metastatic visceral disease (defined as extensive hepatic involvement or symptomatic pulmonary lymphangitic spread).
No active, second potentially life-threatening cancer
Patients with significant autoimmune disease that is active or potentially life threatening if activated
Patients with a history of life-threatening autoimmune disease
Active life-threatening autoimmune disease
An active, second potentially life-threatening cancer
Patients with significant autoimmune disease that is active or potentially life threatening if activated
Patients with a history of life-threatening autoimmune disease
Serious and potentially life-threatening arrhythmia.