Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patients who have >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period are not eligible
Patient has ? grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Grade 2 peripheral neuropathy or higher or grade 1 with pain on clinical examination during the screening period
Patient has >= grade 2 peripheral neuropathy or neuropathy with pain, regardless of grade that is seen on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Peripheral neuropathy >= grade 3 on clinical examination or grade 2 with pain during the screening period
Peripheral neuropathy ? grade 3 on clinical examination or grade 2 with pain during the screening period
Peripheral neuropathy > grade 2 or > grade 1 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Peripheral neuropathy Grade 1 with pain or Grade 2 or higher peripheral neuropathy of any cause on clinical examination during the Screening period.
Peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain during the screening period
Patient has greater than or equal than grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Patient has >= grade 2 peripheral neuropathy on clinical examination during the screening period
Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Patient has >= grade 2 neuropathy, sensory, with or without pain, motor, or autonomic, on clinical examination during the screening period
Grade >= 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has ? grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain during the screening period
Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period.
Patient has ? grade 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination during the screening period
Peripheral neuropathy >= grade 3 on clinical examination or grade 2 with pain during the screening period
Patient has >= grade 3 peripheral neuropathy, or >= grade 2 with pain on clinical examination during the screening period
Peripheral neuropathy >= grade 2 on clinical examination, within 21 days of initiation of protocol therapy
Peripheral neuropathy >= grade 2 on clinical examination, within 21 days of initiation of protocol therapy
Patient has >= grade 1 peripheral neuropathy with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Participant has >= grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy
Patient has > grade 2 peripheral neuropathy on clinical examination during the screening period
Participant has >= grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 2 peripheral neuropathy on clinical examination within 28 days of signing consent
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has grade 3 peripheral neuropathy or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 peripheral neuropathy with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening
Peripheral neuropathy >= grade 2 on clinical examination during the screening period
Patient with >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
No grade 2 or higher neuropathy
Patients with grade 2 or higher peripheral neuropathy will be excluded in the dose escalation phase of the protocol
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not have grade 3 or higher peripheral neuropathy
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not have grade 3 or higher peripheral neuropathy
Patients with peripheral neuropathy of grade 2 or higher
Grade 2 or higher peripheral neuropathy at screening
Grade 1 or higher CNS hemorrhage on baseline brain MRI, or history of grade 2 or higher CNS hemorrhage within 12 months
Uncontrolled Grade 3 or higher infection
Grade 2 or higher peripheral neuropathy or ataxia per NCI CTCAE
Active esophagitis grade B or higher
Patients with grade 2 or higher neuropathy
Patients must not have Grade 2 or higher peripheral neuropathy.
Grade 2 or higher pneumonitis
Grade 3 or higher peripheral neuropathy
No symptoms attributable to grade 2 or higher peripheral neuropathy
Patients with grade 2 or higher peripheral neuropathy are excluded
CTCAE grade 3 or higher peripheral neuropathy
Patients with persistent grade 3 or higher prior vincristine (VCR) (vincristine sulfate)-related neuropathy
Current grade 2 or higher peripheral neuropathy
Grade 2 or higher peripheral neuropathy.
More than one grade 2 or higher transaminase elevation
Patients with grade 2 or higher peripheral neuropathy
participants with Grade 2 or higher residual toxicities from prior therapy (including Grade 2 or higher peripheral neuropathy or any grade neuropathy with pain; excluding alopecia). This includes recovery from any major surgery. Note: Participants with planned surgical to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery.
Grade 2 or higher persisting prior treatment-related neuropathy
Grade 2 or higher peripheral neuropathy
Paclitaxel arm: grade 2 or higher neuropathy
Grade 2 or higher peripheral neuropathy.
Grade 2 or higher peripheral neuropathy per NCI CTCAE
Grade 2 or higher peripheral neuropathy
Patients must not have grade 2 or higher peripheral neuropathy
Active Grade 3 or higher infection.
Patients who have had grade 2 or higher peripheral neuropathy within 14 days prior to registration are not eligible (must have resolved to grade 1 or lower to register)
Peripheral neuropathy or neuropathic pain Grade 2 or higher
Neuropathy grade 2 or higher
Grade 2 or higher peripheral neuropathy (paclitaxel arm only)
Grade 2 or higher neuropathy (CTCAE V4.0)
Subjects with T3 or higher, and N3 disease
Current grade II or higher peripheral neuropathy.
Significant peripheral neuropathy defined as grade 2 or higher
Current grade II or higher peripheral neuropathy.
Peripheral neuropathy that is grade 2 or higher
Grade 3 or higher peripheral neuropathy
Grade 2 or higher peripheral neuropathy per NCI CTCAE
Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to Day 1
Grade 2 or higher neuropathy
Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to the first dose of study drug
Current grade 3 or higher neuropathy
Grade 2 or higher peripheral neuropathy
Grade 2 or higher peripheral neuropathy at the time of study entry
Grade 2 or higher oral mucositis
Grade 2 or higher peripheral neuropathy
Grade II or higher neuropathy
Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose of study drug
Platelets >= 100,000/mm^3, equivalent to CTCAE v 3.0 grade 0-1
Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)
Recovered to ? grade 1 NCI CTCAE version 4.0 from toxicity of prior chemotherapy or biologic therapy administered more than 4 weeks earlier.
Presence of ? CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? CTCAE grade 3) due to prior cancer therapy
Neuropathy, grade 2 or greater by NCI-CTCAE, v 4.0
Ongoing adverse effects from prior systemic treatment > NCI CTCAE Grade 1 (with the exception of Grade 2 alopecia)
Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade 2 or prolongation of the QTcF interval to >480 msec.
Presence of ? CTCAE grade 2 toxicity (except alopecia and ototoxicity, which are excluded if ? CTCAE grade 3) due to prior cancer therapy.
Ongoing infection > grade 2 NCI-CTCAE v4.0
Any Grade >1 (according to the NCI CTCAE 4.03) adverse reaction unresolved from previous treatments and not readily managed and controlled with supportive care.
Grade 2 to 4 peripheral neuropathy (NCI CTCAE v 4.03).
Any ongoing cardiac dysrhythmias of National Cancer Institute (NCI) CTCAE grade > 2, NCI CTCAE grade 4 atrial fibrillation, or corrected QC interval per Fridericia's formula (QTcF) interval > 470 msec, except for documented right bundle branch block, at screening
History or presence of clinically significant ventricular or atrial dysrhythmia >Grade 2 per NCI CTCAE v4.0
Significant recent bleeding history defined as NCI CTCAE grade ?2 within the last 3 months, unless precipitated by an inciting event (e.g., surgery, trauma, injury)
Any history of CTCAE grade ?2 cardiac dysrhythmias within the last 6 months. Patients with non-QTc CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the medical monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety.
Ongoing infection > grade 2 NCI-CTCAE v4.0
Ongoing infection > grade 2 NCI-CTCAE version (v) 4.0
Patients cannot have experienced a significant (CTCAE Grade 3 or 4 with or without neutropenia) infection within 2 weeks of their first dose of MT-3724.
Serum bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1)
Have Grade 3 or 4 peripheral neuropathy per NCI-CTCAE Version 4.0.
Subject has symptomatic cardiac disorders (CTCAE v. 4.03 Grade 3 and 4)
Afebrile (<38°C per CTCAE v4.03);
Patient has not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery is defined as ? NCI-CTCAE Grade 1, except for liver function test levels which must be <Grade 1.
Afebrile (<38°C per CTCAE v4.03);
(Bevacizumab-related exclusion) Any previous venous thromboembolism > NCI CTCAE grade 3
serum potassium NCI-CTCAE version 4.03 Grade <2;
serum calcium NCI-CTCAE version 4.03 Grade <2;
serum magnesium NCI-CTCAE version 4.03 Grade <2;
Evidence of peripheral neuropathy > grade 1 by NCI-CTCAE version 4.03;
Ongoing infection > grade 2 NCI-CTCAE v4.0
Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade >= 2 (CTCAE version [v]4.0)
Patients with hypertriglyceridemia defined as >1000 mg/dL (CTCAE Grade 4).
Otherwise, all toxicity at study entry < Grade 1 by NCI CTCAE v4.00 (Patients with ? Grade 2 neuropathy are eligible).
Grade 3-4 electrolyte abnormalities (CTCAE v 4.03) except sodium, which must be ?126 mmol/L.
Serum creatinine =< 1.5 X ULN (CTCAE grade 1 baseline)
Patients who have active clinically serious infection > CTCAE grade 2 are not eligible
Serum creatinine =< 1.5 x ULN (CTCAE grade 1 baseline)
Patients exhibiting baseline grade 3 or 4 by CTCAE criteria are excluded
Ongoing infection > Grade 2 NCI-CTCAE v 4.03
Creatinine less than 1.5 x ULN (CTCAE Grade 1)
Bilirubin less than 1.5 x ULN (CTCAE Grade 1)
Bilirubin less than or equal to 1.5 x ULN (CTCAE v4 grade 1)
Cardiac dysrhythmias of NCI CTCAE grade >= 2 within the last 28 days
Serious uncontrolled infection > grade 2 (CTCAE v4.0)
Serious uncontrolled infection > grade 2 (CTCAE v4.0)
At least one clinical symptom probably or definitely attributed to KSHV-MCD\r\n* Intermittent or persistent fever for at least 1 week (> 38 Celsius degree [C])\r\n* Fatigue (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or greater)\r\n* Gastrointestinal symptoms (includes nausea and anorexia) (CTCAE grade 1 or greater)\r\n* Respiratory symptoms (includes cough and airway hyperreactivity) (CTCAE grade 1 or greater)
Clinical relevant AEs or laboratory results related to previous anti-neoplastic therapy have not resolved to a NCI-CTCAE grade ?1.
Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
Subjects with neuropathy grade ?2 based on CTCAE v4.03 at the time of study entry
Presence of any CTCAE grade 2 or greater toxicity
Ongoing infection > grade 2 NCI-CTCAE v4.0
Recovery to baseline or ? Grade 1 CTCAE ver.4.0
Patients with ataxia >= CTCAE grade 2 are ineligible
Grade 3-4 electrolyte abnormalities (CTCAE, v. 4):
Triglycerides < CTCAE grade 2
Subjects who have an active clinically serious infection of CTCAE grade >= 2
Bilirubin less than or equal to 1.5 x ULN (CTEP CTCAE version 4.0, grade 1)
Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
Serum creatinine ? 1.5 X ULN (CTCAE Grade 1 baseline)
Ongoing clinical adverse events NCI CTCAE Grade >2 resulting from prior cancer therapies
All prior treatment- related toxicities must be CTCAE (Version 4.0) <=Grade 1 (except alopecia and peripheral neuropathy) at the time of treatment allocation [NCI-CTCAE, 2009].
Neuropathy >NCI-CTCAE Grade 1.
Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
All AEs resulting from prior chemotherapy, surgery, or radiotherapy, must have resolved to at least NCI-CTCAE (v. 4.03) Grade 1 (except for laboratory parameters outlined below).
Ongoing infection > grade 2 NCI-CTCAE v 4.0
Ongoing infection > Grade 2 NCI-CTCAE v4.03.
Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0
Presence of ? CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? CTCAE grade 3) due to prior therapy.
Presence of NCI CTCAE ? grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? NCI CTCAE grade 3) due to prior cancer therapy
Subjects with known Gilbert's syndrome who have serum bilirubin ? 3 x ULN (NCI CTCAE v4.03 Grade 2) may be enrolled.
Any reversible treatment-related toxicity that has not resolved to NCI CTCAE grade =< 1 except neuropathy
Ongoing infection > grade 2 NCI-CTCAE v4.0
? CTCAE Grade 3 anemia, OR
? CTCAE Grade 3 hematoma (bleed)
CTCAE v4.0 grade 3 or 4 anorexia or nausea related to metastatic disease.
Clinically significant bleeding NCI-CTCAE version 4.0 Grade 3 or higher within 30 days before randomization.
Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy
Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0
Bilirubin =< 1.5 x ULN, CTCAE grade 1
Serum albumin greater or equal to 3 g/dl (CTCAE 4.0 grade 1 abnormality is acceptable)
Serum electrolytes within normal limits (CTCAE 4.0 grade 1 abnormality is acceptable)
Resolved acute effects of any prior therapy to baseline severity or Grade ?1 NCI CTCAE.
Any toxicity from prior chemotherapy has resolved or Grade 1 (NCI-CTCAE, Version 4.0)
Ongoing infection > Grade 2 NCI-CTCAE v4.0.
Subject has an ongoing toxicity ? Grade 2 (NCI CTCAE Version 4.03) attributable to prior medication to treat solid tumor (except alopecia) at screening.
Has peripheral neuropathy ? Grade 2 (NCI-CTCAE)
Active, clinically serious infections of NCI CTCAE v4.0 Grade 2 or higher within 4 weeks prior to Cycle 1, Day 1
Subject has an ongoing toxicity greater than or equal to grade 3 (NCI CTCAE version 4.03) attributable to prior NSCLC treatment at the time of screening.
Bilirubin less than or equal to 1.5 x ULN (CTCAE v4.0 grade 1)
Ongoing infection > grade 2 NCI-CTCAE v4.0
Signs of peripheral neuropathy (PN) ? NCI CTCAE Grade 2.
Signs of peripheral neuropathy (PN) ? NCI CTCAE Grade 2.
Anxiety ? CTCAE grade 3
Patients with active clinically serious infections defined as >= grade 2 according to NCI CTCAE, version 4.0
Subjects with valvular heart disease CTCAE (version 4.0) grade 2
Any peripheral neuropathy ? NCI CTCAE Grade 2.
? CTCAE Grade 3 anxiety.
Symptomatic peripheral neuropathy grade ?2 NCI CTCAE v4.0.
Diarrhoea CTCAE v4.03 Grade ? 2
Evidence of uncontrolled bradycardia or other cardiac arrhythmia defined as ?Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension
History of bronchopulmonary hemorrhage NCI CTCAE >/= Grade 2 within 2 months prior to randomization
Evidence of CNS hemorrhage CTCAE ? grade 2 on baseline MRI.
NCI CTCAE (version 4.03) Grade 3 or higher toxicities due to prior therapy that have not shown improvement and are considered to interfere with current study medication
Active clinically serious infections defined as >= Grade 3 according to NCI CTCAE
CTCAE Grade 2 or 3 fatigue.
Any >=Grade 2 hypophosphatemia (per CTCAE v4.0) at the time of enrolment
Active clinically serious infection > NCI-CTCAE grade 2
? CTCAE grade 3 anxiety
Active clinically serious infection > CTCAE v 4.0 grade 2
Active clinically serious infections > Grade 2 (NCI-CTCAE Version 3.0)
follicular lymphoma (NCI CTCAE grade 1 or 2)
Ongoing infection > CTCAE grade 2
Baseline alopecia (defined CTCAE v4.0 grade > 0)
Ongoing infection > grade 2 NCI-CTCAE v4.0
AST > 2.5 x ULN (CTCAE grade 2)
Bilirubin > 1.5 x ULN (CTCAE grade 2)
Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
Current alopecia grade 2 or greater as per NCI-CTCAE v.4.0, or significant hair loss or hair breakage
Hepatic toxicity >= grade 2 (using CTCAE version 4 standard definitions)
Ongoing cardiac dysrhythmias of NCI CTCAE Grade ? 2, uncontrolled atrial fibrillation of any grade, or an average of triplicate QTc interval >470 msec.
Not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade <=1 or baseline.
Serum lipase ? 2 x ULN i.e. equivalent to ? Grade 2 NCI-CTCAE v.4.03
For Adjuvant Treatment: All AEs resulting from surgery must have resolved to NCI-CTCAE (v. 4.03) Grade ? 1
If applicable, patient with >= grade 2 peripheral neuropathy within 14 days before enrollment
Grade 3 peripheral neuropathy within 14 days before enrollment.
> Grade 1 peripheral neuropathy within 14 days before enrollment.
Patient with peripheral neuropathy Grade >2
Patient has >= grade 2 peripheral neuropathy within 14 days of trial enrollment
Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment and at D60-180 after AHCT; patients who had >= grade 2 peripheral neuropathy within 14 days before enrollment but resolves to grade 1 or lower peripheral neuropathy at D60-D180 after AHCT can be enrolled at this time
Patient has >= grade 2 peripheral neuropathy
Patient has >= grade 2 peripheral neuropathy
The patient has peripheral neuropathy >= grade 2
Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
Grade >= 2 peripheral neuropathy within 21 days before enrollment
Patient must not have >= grade 2 peripheral neuropathy within 14 days before enrollment
Patient has >= grade 2 peripheral neuropathy
Patient has >= grade 2 (CTCAE v 4.0) peripheral neuropathy within 14 days before enrollment
Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
Patient has > = Grade 2 peripheral neuropathy within 14 days before enrollment.
Subject has > grade 2 peripheral neuropathy within 14 days before enrollment
Grade >= 2 peripheral neuropathy within 14 days before enrollment
Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.
No grade 2 >= peripheral neuropathy within 14 days before enrollment
Patient has >= grade 2 peripheral neuropathy
If applicable, patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment
Patient has >= grade 2 peripheral neuropathy
If applicable, patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
Patient has >= grade 2 peripheral neuropathy within 14 days prior to treatment initiation
Patients with grade 3 ataxia or grade >1 extrapyramidal movement disorder are not eligible
Any grade I DCIS
Any grade II DCIS without comedonecrosis
Grade II DCIS with comedonecrosis
Patients with a history of Grade 3-4 capillary leak syndrome, or non-cardiac Grade edema are ineligible, e.g., related to SL-401 or other etiology
Note: Subjects with ? Grade 2 neuropathy or ? Grade 2 alopecia are an exception to this criterion and may qualify for the study.
Ongoing adverse event from previously administered systemic anti-cancer therapy unless has recovered to =< grade 1 or at baseline prior to C1D1\r\n* Subjects with any grade alopecia or =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
Must not have experienced any ? Grade 3 AE nor any neurologic or ocular AE of any grade while receiving prior checkpoint inhibitors.
Residual side effects to previous therapy > grade 1 prior to randomization (Alopecia any grade and/or neuropathy grade 2 without pain are permitted)
Grade 3b FL
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
Presence of any of the following conditions, which are risk factors for RVO: Uncontrolled glaucoma with intraocular pressure >21 millimetres of mercury (mm Hg); Serum cholesterol >/=Grade 2; Hypertriglyceridemia >/=Grade 2; Hyperglycemia (fasting) >/=Grade 2; Grade >/=2 uncontrolled hypertension (participants with a history of hypertension controlled with anti-hypertensive medication to Grade </=1 are eligible)
Hyperglycemia (fasting) ? Grade 2
Have experienced a Grade ?3 AE or a neurologic or ocular AE of any grade while receiving prior immunotherapy.
Histologically confirmed low grade (grade 1 or grade 2) noninvasive (Ta) urothelial carcinoma of the bladder with a new recurrence that meets the following criteria:\r\n* Total tumor burden =< 3 cm in size (multiple lesions permitted)\r\n* Low grade appearance (grade 1 or grade 2)\r\n* Noninvasive appearance (Ta)\r\n* No history of carcinoma in situ (CIS) within the last 3 years or lesions concerning for CIS\r\n* Negative urine cytology (atypical or suspicious for low grade neoplasm are considered negative) within 5 years\r\n* Eligible for surgery\r\n* Urothelial carcinoma of the bladder recurrence can be confirmed by either cystoscopic visual evaluation or histologic evaluation of a biopsy sample
History of high grade disease
LOW GRADE B-NHL PATIENTS ONLY
Symptomatic loco-regional disease that causes ongoing grade 3 or grade 4 urinary or rectal symptoms
Residual side effects to previous therapy > Grade 1 prior to initiation of therapy (Alopecia any grade and/or neuropathy Grade 1 without pain are permitted)
Ongoing Grade >1 proliferative or nonproliferative retinopathy.
Ongoing severe graft-versus-house disease (GVHD) with Grade ?2 serum bilirubin, Grade ?3 skin involvement, or Grade ?3 diarrhea at the start of study therapy.
All acute toxic effects of any prior antitumor therapy resolved to ?Grade 1 before the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted], or neurotoxicity [Grade 1 or 2 permitted], or selected laboratory parameters [Grade 1 or Grade 2 permitted with exceptions as noted below]).
Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4 weeks of screening. The Grade 1 subset includes patients who have either epistaxis, hematuria, oral petechiae, or bleeding at invasive or other wound sites.
Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0
High risk RCC: pT4, Any Grade N0, M0; pT, Any stage, Any Grade, N+, M0
History of grade >= 2 radiation proctitis
Peripheral neuropathy > grade 1, except for grade 2 without limitations on instrumental daily life activities;
Residual side effects to previous therapy > grade 1 prior to initiation of therapy (alopecia any grade and/or neuropathy grade 2 without pain are permitted)
Patients with carcinosarcoma, mucinous, low grade endometrioid, or low grade serous histology evident on pretreatment biopsy
Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis
Grade 3 or above neuropathy induced from prior treatment, that is not resolved to grade 2 or below despite best supportive care
Patients will be excluded if they currently have the following risk factors for retinal vein occlusion (RVO): (1) uncontrolled glaucoma with intra-ocular pressures >= 21 mmHg (2) serum cholesterol >= grade 2 (3) hypertriglyceridemia >= grade 2 (4) hyperglycemia (fasting) >= grade 2
Patients will be excluded from study participation if they currently are known to have any of the following risk factors for RVO: a. Glaucoma with intraocular pressure >= 21 mmHg b. Grade >= 2 serum cholesterol c. Grade >= 2 hypertriglyceridemia d. Grade >= 2 or symptomatic hyperglycemia (fasting) e. Grade >= 2 uncontrolled hypertension (patients with a history of hypertension controlled with anti-hypertensive medication to grade =< 1 are eligible
Patients who have residual toxicities > grade 2 attributed to taxane therapy, except for neuropathy, who are excluded if > grade 1
Subjects with low grade tumors (histologic grade 1/3)
PRIOR TO LYMPHODEPLETION: For grade 4 neutropenia, ? grade 3 febrile neutropenia, or grade 4 thrombocytopenia, hold bendamustine until toxicity resolve to ? grade 2
The risk factor for RVO are listed below; exclusion should be considered by clinical discretion if they have the following conditions:\r\n* Uncontrolled glaucoma with intra-ocular pressures > 21 mmHg\r\n* Serum cholesterol >= grade 2\r\n* Hypertriglyceridemia >= grade 2\r\n* Hyperglycemia >= grade 2
Evidence of > grade 1 central nervous system (CNS) hemorrhage or > grade 3 venous thromboembolism
FIGO grade 1 or 2 endometrioid cancer
Subjects who are receiving any concurrent investigational or conventional agent with known or suspected activity against multiple myeloma, or those whose adverse events due to agents administered more than 4 weeks earlier have not recovered to a severity of grade 0 or grade 1; subjects with chronic grade 2 toxicities may be eligible per discretion of the investigator and M. D. Anderson Cancer Center (MDACC) Investigational New Drug (IND) Office (eg, grade 2 chemotherapy-induced neuropathy)
COHORT I: Non-bevacizumab failure, i.e. either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen, such as:\r\n* >= grade 3 hypertension not controlled by medication, hypertensive crisis, or hypertensive encephalopathy\r\n* >= grade 3 proteinuria that does not resolve or nephrotic syndrome\r\n* Any grade gastrointestinal (GI) perforation\r\n* >= grade 3 infusion-related reaction\r\n* >= grade 3 wound healing complications\r\n* >= grade 3 hemorrhage or any grade central nervous system (CNS) hemorrhage or >= grade 2 hemoptysis\r\n* Any grade arterial thromboembolic event (e.g. myocardial infarction or cerebral infarction) or >= grade 3 venous thromboembolic event\r\n* Any grade posterior reversible encephalopathy syndrome (PRES)\r\n* >= grade 3 congestive heart failure\r\n* >= grade 2 non-GI abscesses and fistulae
AT THE TIME OF INFUSION: Recurrent or refractory HER2-positive GBM\r\n* Immunohistochemistry (IHC) or reverse transcriptase-polymerase chain reaction (RT-PCR) will be used to determine HER2 positivity; results will be compared to standard controls; HER2 expression in tumors on IHC should be ? grade 1 and ?1+ intensity score; wherein grades are defines as: grade 0: no staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100% of cell staining for HER2 and intensity scores are: negative; 1+; 2+ and 3+ using breast cancer standard arrays as a guide for intensity
at least 3 grade 3 CIRS-G comorbidities OR
No peripheral edema >= grade 2 at baseline
All irAEs while receiving prior immunotherapy must have resolved to ? grade 1 or Baseline prior to Screening for this study. Must not have experienced a ? grade 3 immune-related AE within the past 16 weeks or any grade 4 life- threatening irAE (regardless of duration) or neurologic or ocular AE of any grade while receiving prior immunotherapy (NOTE: Subjects with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy, but must have no history of adrenal crisis and be asymptomatic)
-  Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks first dose
Participants must be otherwise indicated for radiation therapy independent of this study:\r\n* For low-grade gliomas, typical indications would include at least one of:\r\n** Progressive or recurrent disease as defined by imaging\r\n** Persistence or progression of neurological symptoms (e.g., seizures), or\r\n** At risk of early progression as defined by either (a) age >= 40, (b) mindbomb homolog 1 (MIB-1) >= 3%, or (c) size > 6 cm and/or of limited resectability\r\n* For favorable grade III gliomas, typical indications would be at upfront diagnosis following maximal safe surgery or a recurrence of a lower grade tumor with metaplastic evolution to grade III disease
Pap test documenting atypical squamous cells of undetermined significance (ASCUS)/HPV+, atypical squamous cells high grade (ASC-H), low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL) within 4 months prior to screening Visit 1;
Patients with the following histologies: \r\n* Diffuse astrocytoma (grade 2)\r\n* Oligodendrogliomas (any grade)\r\n* Pleomorphic xanthoastrocytoma (PXA, any grade)
Patients must have a creatinine and AST =< grade 1
AST =< grade 1
Subjects who experienced grade 3 or 4 toxicity regardless of causality to the cell infusion must have had a reduction to a grade 1 or less or returned to baseline levels
< Grade 2 hypo/hyperkalemia
< Grade 3 hypo/hyperphosphatemia
< Grade 3 hypo/hypermagnesemia
Any grade T1 papillary disease OR
Known persistent (> 4 weeks) ? Grade 2 neutropenia, ? Grade 2 thrombocytopenia or > Grade 3 anemia from prior cancer therapy
Grade 3b FL
Must not have experienced a ? Grade 3 AE or neurologic or ocular AE of any grade while receiving prior immunotherapy
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of first dose
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
Sodium levels =< grade 1
Grade >1 retinopathy
EXPANSION COHORT ONLY: Resolution of any pre-existing toxicity from prior therapy to NCI CTCAE version 4.0 =< grade 1 except neuropathy (=< grade 2) and tinnitus (=< grade 2), and hearing loss (=< grade 4)
Patients must not have a history of grade >= 2 neurological toxicity with previous treatment, or persistent grade >= 2 peripheral neuropathy; drowsiness and lethargy were exempted from this criteria unless previously persistent for more than one week
Grade >1 retinopathy
Toxicity recovery should include the following:\r\n* Grade =< 2 neuropathy\r\n* Grade =< 2 diarrhea\r\n* Grade =< 2 mucositis
Known grade 3 or 4 neurotoxicity
Peripheral edema > grade 1
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 as below:\r\n* Grade 0: Up and about, no restriction\r\n* Grade 1: Ambulatory, no strenuous activity\r\n* Grade 2: Ambulatory, capable of self-care appropriate for age; up and about > 50% of time, but unable to carry out any physical activities or attend school\r\n* Grade 3: Limited self-care only; up and about < 50% of time\r\n* Grade 4: Disabled, no self-care; bedridden or confined to chair
Hypertriglyceridemia >= Grade 2
Hyperglycemia (fasting) >= Grade 2
Grade 3b FL
Histologically documented FL (Grade 1, 2 and 3A)
High grade (or grade 3) serous histology or known to have gBRCAmut
Persistent grade 2 fatigue at Baseline.
Peripheral edema ? grade 2 within 2 weeks prior to study day 1.
Grade >=2 hypercholesterolemia or hypertriglyceridemia
Baseline peripheral edema >= grade 3
Significant peripheral neuropathy (Grade 3, Grade 4, or Grade 2 with pain) within 14 days prior to first dose
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before study treatment
Grade 3b FL
Grade >=2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
Has not recovered (ie, to ? Grade 1 or to baseline) from chemotherapy induced AEs. Note: Patient with ? Grade 1 neuropathy or ? Grade 2 alopecia is an exception to this criterion and may qualify for the study. Persistent > Grade 2 toxicity from prior cancer therapy
Has not recovered (ie, to ? Grade 1 or to baseline) from chemotherapy induced AEs. Note: Patient with ? Grade 1 neuropathy or ? Grade 2 alopecia is an exception to this criterion and may qualify for the study. Persistent > Grade 2 toxicity from prior cancer therapy
Serum creatinine level greater than CTC grade 2.
No significant immune-related adverse event due to the nivolumab plus ipilimumab dose received in the neoadjuvant setting, as follows:\r\n* Any grade myocarditis, including an asymptomatic troponin elevation felt to be related to nivolumab plus ipilimumab\r\n* Any grade neurologic complication (e.g. meningitis, encephalitis, neuropathy); study chair should be contacted if there is any question whether an adverse event (AE) was neurologic in nature\r\n* Grade 2 or higher pneumonitis\r\n* Grade 2 colitis\r\n* Grade 2 or higher anemia (due to drug; unrelated anemia is not exclusionary)\r\n* Thyroid/adrenal AEs regardless of grade that have stabilized or are clinically asymptomatic are eligible\r\n* Fatigue, regardless of grade, is not a contraindication to randomization\r\n* Grade 4 AST or ALT elevation\r\n* Asymptomatic elevated amylase and lipase, regardless of grade, are not contraindications to randomization\r\n* Grade 4 rash; grade 3 rash is not a contraindication to randomization; any oropharyngeal lesions or bullous skin lesions that are suggestive of toxic epidermal necrolysis or Stevens-Johnson syndrome are contraindications to randomization regardless of the grade of rash\r\n** If not specified above, other Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher AEs deemed possibly related to the nivolumab plus ipilimumab are exclusions to randomization; AEs that were attributable to surgery or adjuvant RT would not be contraindications to randomization
Any tumor grade
At least a fifth grade education
Histologically confirmed BE with high grade dysplasia, invasive carcinoma of the esophagus, low grade dysplasia
Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified Radiation Therapy Oncology Group (RTOG) scale:\r\n* Grade 0 – None\r\n* Grade 1 – Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary)\r\n* Grade 2 – Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods)\r\n* Grade 3 – Complete dryness of mouth (no response on stimulation and difficult oral alimentation; intravenous (IV) fluids, pureed diet or tube feedings may be required)\r\n* Grade 4 – Fibrosis
Grade 3 disease
Patients on adjuvant ipilimumab are allowed to participate at least 30 days from drug discontinuation as long as they have at most grade 1 adverse events (or grade 2 if they have to received hormone replacement therapy for their otherwise grade 1 ipilimumab-induced autoimmune endocrinopathies)
Subjects with a history of low or high grade dysplasia
No significant esophagitis (LA grade < B, C and D).
Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior cycle 1, day 1
Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior to screening
Significant neuropathy (grades 3–4, or grade 2 with pain) within 21 days prior to registration
Significant neuropathy (grades 2 or grade 1 with pain) within 14 days prior to enrollment
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
Significant neuropathy (grades 3–4, or grade 2 with pain)
Must not have any significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrollment.
Significant neuropathy (grades 3 to 4 or grade 2 pain)
Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior to randomization
Patients who have experienced significant neuropathy (grades 3-4 or grade 2 with pain) within 14 days prior to registration are NOT eligible for participation
Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to enrollment
Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to enrollment
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to the first day of treatment
No significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to cycle 1 day 1
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to signing consent
Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to enrollment
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
Significant neuropathy (grades 3 to 4, or grade 2 pain)
Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to randomization
Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior to randomization
Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.
Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
Grade >= 2 neuropathy
Baseline neuropathy of > grade 2
SAFETY RUN-IN: Patients with baseline grade 2 neuropathy
>= grade 3 neuropathy at the time of enrollment
Neuropathy > grade 1
CTCAE Grade > 2 neuropathy
Neurosensory neuropathy > grade 2 at baseline.
Neuropathy ? Grade 2.
Patients with a history of grade >= 2 neuropathy
Patients with >= grade 2 neuropathy
Significant neuropathy > grade 2 at the time of first dose or within 14 days of enrollment
Neuropathy > grade 1
Patients with any baseline grade 2 neuropathy
Grade 3 baseline neuropathy
Neuropathy: patients must have =< grade 1 neuropathy at enrollment
Neuropathy =< grade 1 at the time of registration
Diabetic neuropathy (any grade)
Neuropathy grade >1
Neuropathy >= grade 1
Patient has baseline neuropathy of >= grade 2
Significant neuropathy (grade 3, grade 4) at the time of the first dose and/or within 14 days before enrollment
Neuropathy > Grade 1
Neuropathy (?grade 2 CTCAE)
Patients with >= grade 2 neuropathy
No grade >= 2 neuropathy
Ongoing grade >= 3 neuropathy
Baseline neuropathy > grade 1
Patient has baseline neuropathy of > grade 2
Neuropathy Grade > 3
Grade <= 2 neuropathy
Neurosensory neuropathy ? grade 2 at baseline.
Neuropathy CTCAE grade > 2
Patients with > grade 1 neuropathy
Subjects with >= grade 2 neuropathy
Evidence of ? Grade 2 neuropathy
Neuropathy > Grade 1.
Patients with symptomatic neuropathy
Patients with >= grade 2 neuropathy
Significant neuropathy (? Grade 3) within the 14 days prior to randomization
Subjects with >= grade 2 neuropathy
Neurosensory neuropathy ? grade 2 at baseline
Significant neuropathy >= grade 3 or grade 2 neuropathy with pain at baseline
Significant neuropathy >= grade 3 or grade 2 neuropathy with pain at baseline
> Grade 3 neuropathy
Grade >1 neuropathy
History of Grade ?2 neuropathy
Patient has baseline neuropathy of >= grade 2
Neuropathy > grade 2
Significant neuropathy >= grade 3 or grade 2 neuropathy with pain at baseline
? Grade-2 neuropathy
No current grade 2, 3, or 4 of neuropathy
Patients with any neuropathy > Grade 1
Clinical evidence of neuropathy
Significant neuropathy >= grade 3 at baseline
Patients with any neuropathy.
Patients with neuropathy > grade 1
Subject has Neuropathy ? Grade 2 at Screening.
With < or = grade 2 neuropathy
> grade 2 neuropathy
Patients with grade III-IV neuropathy
Grade 2 or above neuropathy
Presence of ? Grade 2 neuropathy.
Neuropathy Grade 3 or more
Grade >= 2 neuropathy
Neuropathy >= grade 2 (moderate neuropathy that limits instrumental activities of daily living)
Subject has ? CTCAE v4.03 Grade 2 neuropathy.
Neuropathy: no baseline neuropathy grade > 2
Known diabetic neuropathy
Greater than Grade 2 neuropathy or ? Grade 2 neuropathy with pain at baseline, regardless of whether or not the patient is currently receiving medication
Has neuropathy ? Grade 2.