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).