Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.
Adequate physical function as measured by all of the following:
In addition, patients with abnormal renal function may be included if the abnormal function is due to allograft dysfunction resulting from diagnosis of PTLD, or from reduction/cessation of immunosuppression aimed at treatment of PTLD
Any condition that could potentially alter immune function (AIDS, multiple sclerosis, diabetes, renal failure)
Has adequate hematopoietic, coagulation, renal and hepatic function. Subject must remain eligible for continued treatment with tazemetostat according to the eligibility and treatment criteria from the antecedent study.
Any condition that could potentially alter immune function (AIDS, multiple sclerosis, diabetes, renal failure)
Participants with unilateral pleural effusion will be eligible for inclusion if they fulfill the Global Initiative for Obstructive Lung Disease classification of - level for pulmonary function and New York Heart Association (NYHA) classification class for cardiac function
Liver function abnormality; patients who have liver function tests (LFTs) (including total bilirubin, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) >= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician; unless there is a clear precipitating factor (such as an azole, methotrexate, Bactrim or another drug); if the GI physician considers that HCT on the high-intensity arms of protocol is contraindicated for that patient the patient may be considered for treatment on the lower intensity arm of the protocol or excluded from the protocol; patients with Gilberts syndrome and no other known liver function abnormality and patients with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the high-intensity arms of the protocol
Adequate organ function: Patients should have adequate hepatic, renal, cardiac and pulmonary function to undergo reduced intensity HCT based upon local institutional guidelines, or at a minimum meet requirements noted in eligibility checklist Appendix A-VIII_. However, significant hepatic and pulmonary dysfunction, if secondary to underlying LCH disease activity, will not exclude patients from protocol enrollment and should be discussed with the National PI Coordinator and the Coordinating Principal Investigator.
Decreased renal function with a GFR of less than ml/.m/min.
PFT (pulmonary function test) with a FEV > . liters/second within weeks prior to study registration.
Adequate peripheral nervous system (PNS) function defined as:\r\n* PNS toxicity < grade
Baseline pulmonary function tests (PFTs) available or will be obtained prior to treatment start
Subject has adequate pulmonary function defined as:
Adequate organ function, including renal and hepatic function based on the last assessment performed within the Screening Period Patients enrolled in the Dose Finding Portion of the Study:
Evidence of significant cardiovascular disease including history of recent (< months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional premature ventricular contractions (PVC's), angina, positive low-level stress test, or cerebrovascular accident; all patients should have baseline pulmonary function tests; adequate pulmonary function should be documented (forced expiratory volume-one second [FEV] > liters or >= % of predicted for height and age) prior to initiating therapy
If elevated liver function tests develop at the time of initial presentation or develop during workup and are the result of mechanical obstruction of the biliary drainage by tumor compression or invasion, a biliary drain may be placed; if drainage allows the liver function tests to come within inclusion criteria, the patient may be enrolled
INR > . or other evidence of impaired hepatic synthesis function.
Adequate cardiopulmonary reserve defined as follows as assessed within months of study entry:\r\n* Predicted postoperative forced expiratory volume FEV > L\r\n* Normal left ventricular function (ejection fraction EF ? %) and right ventricular function\r\n* No pulmonary hypertension noted on preoperative transthoracic echocardiography
History of impaired adrenal gland function (eg, Addison's disease, Cushing's syndrome).
FEV < % (based on absolute percent predicted using United States of America [USA]-ITS-NIH equation) on pulmonary function testing
Cardiac function suitable for protocol-required hydration as determined by the investigator and/or cardiologist
Adequate pulmonary and cardiac function: no clinical evidence of cardiopulmonary disease, which, in the opinion of the investigator, precludes enrollment
Concomitant disease or malformation severely affecting the cardiovascular, pulmonary, liver or renal function
Patients must not have a history of any immune system disorder, or laboratory abnormality or any condition that could potentially alter immune function
Respiratory Function: Adequate respiratory function in the opinion of the Investigator with no clinically significant uncontrolled respiratory disease.
Immunological Function: Adequate immune system function in the opinion of the Investigator with no known immunodeficiency disease.
Renal and hepatic function values exceeding times the upper normal value
The patient has adequate pulmonary function
Cardiopulmonary function criteria:
Patients with abnormal hepatic function will be eligible and will be grouped according to criteria; patients with active hemolysis should be excluded; no distinction should be made between liver dysfunction due to metastases and liver dysfunction due to other causes; this data will be captured in the case report form (CRF); registration laboratory investigations will be used to assign a patient to a hepatic function group; hepatic function tests should be repeated within hours prior to starting initial therapy and may result in patients group assignment being altered if different to registration test results
Pulmonary function tests (PFT)s > % of predicted
Adequate hepatic and renal function (these must be WNL or verified by study chair to be related to conditions not interfering with normal health status)
Requirement of re-transplantation for primary non function
Subjects must have adequate hematopoietic function as evidenced by:
Hematology/biochemistry (as dictated by local hospital practice) should indicate fitness for randomization options and parameters should be in line with considerations specified in the summary of product characteristics; hematological parameters should not be supported by transfusion to enable entry into the trial; liver function and renal function tests must form part of the pre-treatment assessment for patients who may be randomized to receive paclitaxel, ifosfamide, and cisplatin (TIP) chemotherapy e.g. patients with impaired renal function may not be considered for arms B and C of InPACT-neoadjuvant but may be considered for arm A
Adequate blood clotting function
Chemistry panel obtained days prior to registration on study, with adequate organ function
Adequate cardiovascular function
Normal clinical assessment of pulmonary function
Inclusion Criteria:\n\n Patients with histologically or cytologically confirmed advanced solid malignancy or\n Lymphoma\n\n Relapsed or refractory disease after at least prior systemic treatment for the primary\n malignancy and not a candidate for other curative treatment.\n\n Adequate hematologic status\n\n Adequate coagulation function\n\n Adequate hepatic function\n\n Adequate renal function\n\n Exclusion Criteria:\n\n Known primary tumors of central nervous system disease\n\n Known active brain metastases\n\n Known cardiopulmonary disease
Known or suspected defect in the function of the urea cycle.
Renal function\r\n* >= ml/min/. m^ for subjects between -\r\n* >= ml/min/. m^ for subjects between -\r\n* >= ml/min/. m^ for subjects > years old\r\n** Renal function criteria based on our previous experience with Y-DOTATOC therapy and known changes in GFR with age
Impaired pulmonary function
Adequate neurologic function
Abnormal heart function
Any conditions that could potentially alter immune function (AIDS, multiple sclerosis, diabetes, renal failure)
Any conditions that could potentially alter immune function (AIDS, multiple sclerosis, diabetes, renal failure)
Adequate liver function (bilirubin less than or equal to . mg/dl, unless considered due to tumor), and renal function (creatinine less than or equal to . mg/dl, unless considered due to tumor)
Prior therapy with modulators of monocyte or TAM function.
History of impaired adrenal gland function
substantially impaired gastrointestinal function
Patients must be suitable candidates for treatment with standard regimens; this includes having adequate hematologic parameters, liver function and renal function based on labs that are deemed acceptable for treatment by the investigators
Adequate white blood cell counts (with low blast counts), liver function, and renal function
Minimum pre-treatment online neurocognitive function (tNCF) score >=
Patients with biliary obstruction for which a stent has been placed are eligible, provided the stent has been in place for at least days prior to the first dose of belinostat and the liver function has stabilized; two measurements at least days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis
normal immune function
Chemistry, liver function tests, renal function, total CPK and hematology lab results must be ? Grade at the time of screening;
For subjects with NORMAL OR MILDLY IMPAIRED RENAL FUNCTION (Control group); to be tested within days of starting the study treatment:
CARDIOPULMONARY FUNCTION CRITERIA
Abnormal heart function
Adequate pulmonary function
Basic metabolic and hepatic function panels
Myopathic or rheumatologic disease that impacts physical function
Subjects must have intact preoperative erectile function, sufficient for penetrative intercourse without medication nor assistive device, as defined by a Sexual Health Inventory for Men/International Index of Erectile Function (SHIM/IIEF)- score or higher, which is collected as part of routine care.
Inability to perform pulmonary function testing (PFT), as determined by the enrolling investigator or PFT lab
Impairments in physical function, as defined by a score < on the SPPB pre-screen
As per medical record, moderate erectile functioning pre-surgery (i.e., or greater on the International Index of Erectile Function [IIEF] Erectile Function Domain [EFD] score, or graded their erections as a or on the standard point Urology Erectile Function scale, or have a score of or greater on the - pre-surgery erectile function scale on the SMRP assessment or have a total score of or greater on items - on the Prostate Quality of Life Survey: Sexual Domain)
Neurological function class of -
Myopathic or rheumatologic disease that impacts physical function
Patients with normal hepatic function according to MD Anderson testing standards and no prior liver disease
Minocycline trial only: patients with adequate hepatic function according to MD Anderson testing standards
Renal function < % of normal for age and size as determined by the Schwartz formula
Corrected DLCO > % by pulmonary function test
Requirement for CD+ stem cell selection for a second infusion of stem cells following an allogeneic stem cell transplant from a related or unrelated adult donor for the following conditions:\r\n* Primary graft rejection\r\n* Secondary graft rejection\r\n* Poor graft function \r\n* Disease recurrence\r\nNote: pre-infusion conditioning with chemotherapy and/or immunotherapy to be determined by the primary BMT physician and the protocol principal investigator (PI) based on clinical condition of the patient\r\n* Specific Organ System Function Requirements from PBMT \r\n** Myeloablative\r\n*** Cardiac (shortening fraction of > % by echo or ejection fraction of > %)\r\n*** Renal (creatinine clearance or glomerular filtration rate [GFR] >= ml/min, or > ml/min.. m^)\r\n*** Pulmonary (DLCO > % by pulmonary function test [PFT])\r\n*** Liver (AST/ALT no greater than times the upper limit of normal)\r\n** Reduced Intensity\r\n*** Cardiac (shortening fraction of > % by echo or ejection fraction of > %)\r\n*** Renal (creatinine clearance or GFR >= ml/min, or > ml/min . m^)\r\n*** Pulmonary (DLCO > % by PFT)\r\n*** Liver (AST/ALT no greater than times the upper limit of normal)
Patients with biliary obstruction for which a stent has been placed are eligible, provided the shunt has been in place for at least days prior to the first dose of romidepsin and the liver function has stabilized; two measurements at least days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis
Color blindness (cannot complete DelisKaplan Executive Function System [D-KEFS] Stroop test)
Patients with impaired renal function (eGFR < )
Patients with an estimated GFR (eGFR) > ml/min reported within days, and who have not had intervening chemotherapy or other treatment or condition that might deteriorate renal function, may receive any gadolinium agent
No clinically relevant deviations in renal function (Serum Creatinine > Grade CTCAE v..). Maximal interval between confirmation and injection of F-FSPG is one week.
Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.
Myopathic or rheumatologic disease that impacts physical function (PCS study)
Impaired renal function defined as eGFR< mL/min/.m