For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
Corticosteroid dose must be stable or decreasing for at least 5 days prior to the baseline MRI scan
Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
For patients with CNS tumors, any baseline neurologic deficit, including seizures, must be stable for at least one week prior to initiating study treatment
Corticosteroids: Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Patients with a history of venous thrombotic episodes such as deep venous thrombosis, pulmonary embolus occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy; similarly, patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy
Concomitant medications\r\n* Corticosteroids: Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid \r\n* Investigational drugs: Patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: Patients who are currently receiving other anti-cancer agents are not eligible
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Prior or concurrent therapy with SSA is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as systemic treatment
Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Subjects with CNS disease must have been on a stable dose of steroids for 2 weeks prior to their biopsy and must not have progressive hydrocephalus at enrollment.
Participants with active infection(s) for which they are receiving drug treatment unless the clinical status is judged to be stable and survival is estimated to be at least 6 weeks
Neurologic status\r\n* Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment\r\n* Patients with seizure disorders may be enrolled if seizures are well controlled on an anti-epileptic drug that is not a strong inducer or inhibitor of CYP3A4/5 are eligible
Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment
Stable (without evidence of progression by imaging [using same imaging modality for each assessment] for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline)
Stable brain metastasis allowed (> 2 weeks, clinically stable post treatment with surgery +/- radiation or radiation alone and off steroids)
Stable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatment
Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months
Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible
Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment
Stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
Stable dose of corticosteroids for at least 7 days
Stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
If patients are on corticosteroids, they must have been on a stable or decreasing dose >= 5 days prior to obtaining their baseline gadolinium (Gd)-magnetic resonance imaging (MRI) of brain; this MRI is to be obtained within 28 days of registration; NOTE: If patient needs escalation of steroids prior to therapy, or are on unstable doses of steroids they are not eligible
Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of the treatment and/or for at least 5 days before starting treatment
For subjects on corticosteroids for endocrine deficiencies or tumor-associated symptoms, must be on a stable (or decreasing) dose for at least 7 days before first dose of study treatment.
Radiographically-confirmed progression of, or recurrent, primary or secondary Grade IV glioma, and must be on a stable or decreasing dose of steroid for at least five days prior to the date of informed consent.
Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration
Patients who are on dexamethasone must be on a stable or decreasing dose for at least one week prior to registration
Subjects receiving corticosteroids must be on a stable or decreasing dose of corticosteroid for the prior 7 days
Stable brain metastases allowed (> 2 weeks, clinically-stable post treatment with surgery +/- radiation or radiation alone and off steroids)
Participants must have bi-dimensionally measurable disease with a minimum measurement of 1 cm per dimension on MRI performed within 14 days prior to registration; if receiving corticosteroids, participants must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline MRI
Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy (unless dose has been stable for 3 months prior to Baseline and will remain stable during the trial), immunosuppressive therapy, corticosteroids >20 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin) within 14 days prior to initiation of study drug.
Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic or untreated or not stable for >= 3 months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks
Patients taking a cholesterol lowering agent must be on a single medication and on a stable dose for at least 4 weeks
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
Stable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatment
Thyroid function tests must be consistent with stable thyroid function; patients on a stable dose of thyroid replacement therapy for a suggested minimum of 3 weeks before cycle 1, day 1 are eligible
Participants with known brain metastases or evidence of leptomeningeal involvement are eligible only if these lesions are treated and both clinically and radiographically stable for at least four weeks; patients are eligible if they are being treated with a stable dosage of steroids/anticonvulsants, requiring no dose increase for 4 weeks
Stable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatment
Uncontrolled cancer pain. Participants requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrollment.
Steroid regimen stable or decreasing for at least 7 days prior to inoculation
they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline),
Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible.
Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment.
Patients receiving systemic corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of systemic corticosteroid; Note: patients who are using topical or inhaled corticosteroids are eligible
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible
Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration
Corticosteroids: patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration
Pain symptoms should be stable (of tolerable Grade 2 or less).
For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment
Stable or decreasing steroid dose within 2 weeks of first dose of study drug if patient is taking steroids. No steroid use is also acceptable.
For patients with HGG and receiving glucocorticoid therapy, must be on stable or decreasing equivalent daily dose of glucocorticoids for 2 weeks (14 days) prior to dose assignment
Patients receiving unstable or increasing doses of corticosteroids; if patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms other than CNS related, dose must have been stabilized (or decreasing) for at least 5 days before first dose of INC280
Patients with neurological deficits should have deficits that are completely stable for a minimum of 1 week (7 days) prior to enrollment
INCLUSION CRITERIA FOR STRATUM C: Patients with neurological deficits should have deficits that are completely stable for a minimum of 1 week (7 days) prior to enrollment
Systemic corticosteroids are permissible in the following circumstances:\r\n* Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (=< 7 days) must have been discontinued at least 7 days prior to study treatment\r\n* Ongoing administration of a stable dose of corticosteroid therapy (previously received for >= 30 days) is permissible provided there is evidence of measurable disease and there will be no increase in steroid dose during the clinical trial
Corticosteroids: patients who are receiving dexamethasone or other corticosteroids must be on a stable or decreasing dose for at least 1 week prior to enrollment; it is recommended that patients be off all steroid therapy or receive the least dose that will control their neurologic symptoms
Patients with neurological deficits that are stable for a minimum of one week prior to registration
Any neurologic deficits must be stable for >= 1 week
Patients must be maintained on a stable corticosteroid regimen for 5 days prior each magnetic resonance (MR)-PET scan
Patients enrolling in the medical arm (Arms C and D) must be on a stable or decreasing dose of corticosteroids (or none) for at least 5 days prior to the baseline MRI;
Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment and/or for at least 5 days before starting treatment
If on corticosteroids for mass effect and/or edema related to the tumor, patient must be on a stable or decreasing dose for at least 2 weeks prior to study entry
Deep vein thrombosis or pulmonary embolism =< 4 weeks before first dose of protocol-indicated treatment, unless adequately treated and stable.\r\n* Patients receiving therapeutic non-coumarin anticoagulation are eligible, provided they are on a stable dose (per investigator judgment) of anticoagulant.
Central nervous system (CNS) metastasis, unless asymptomatic and stable with no change in CNS disease status for at least two (2) weeks prior to initiating protocol-indicated treatment.\r\n* Anticonvulsant and/or corticosteroid prophylaxis (=< 10 mg/day prednisone or equivalent daily) will be allowed if patient is on a stable or decreasing dose of such treatment for at least 14 days prior to initiating protocol-indicated treatment.
Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.
If patient has known brain metastases, must have stable neurologic status following local therapy for at least 4 weeks without the use of steroids or on stable or decreasing dose of ?10 mg daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs).
Receiving stable-­dose somatostatin analog (long-­acting release [LAR], depot) for > 3 months before enrollment
The subject is neurologically stable for at least 2 weeks prior to Screening.
STRATUM A: Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to study enrollment with no plans for escalation
STRATUM B: Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to study enrollment with no plans for escalation
STRATUM C: Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to study enrollment with no plans for escalation
Corticosteroid dose must be stable or decreasing for at least 3 days prior to the baseline MRI scan.
For cohort 4 only (glioblastoma), patients must either not be receiving steroids, or be on a stable dose of steroids for at least five days prior to registration
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment
Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)
Initiating bisphosphonate, or RANKL antibody therapy or adjusting the dose/regimen within 30 days prior to cycle 1 day 1 is prohibited; patients on a stable bisphosphonate regimen are eligible and may continue
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Phase I patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the baseline MRI
Corticosteroids: patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration
Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration
Active brain metastases (e.g., stable for < 2 weeks, symptomatic, no adequate previous treatment, requiring treatment with anti-convulsants); dexamethasone therapy will be allowed if administered as stable or decreasing dose for at least 3 weeks before randomization otherwise no steroids to exceed prednisone 10 mg/day prior to starting trial treatment; symptomatic or uncontrolled central nervous system (CNS) metastasis
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment.
Patients receiving bisphosphonate or denosumab therapy must have been on stable doses for at least 4 weeks prior to screening
Patients with “treated and stable” brain lesions of a duration of > 4 weeks may be enrolled
No active auto-immune disease and not on therapy for auto-immune disease. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible. Patients who have adrenal insufficiency and hypophysitis from prior immunotherapy if they are on stable medical replacement doses are eligible
Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to registration
Corticosteroid dose must be stable or decreasing for at least 3 days prior to the baseline CT or MRI scan
Central nervous system (CNS) metastasis, unless asymptomatic or previously treated and stable; and no evidence of CNS progression for at least 30 days prior to initiating protocol-indicated treatment; anticonvulsant and/or corticosteroid therapy will be allowed if patient is on a stable or decreasing dose of such treatment for at least 30 days prior to initiating protocol-indicated treatment
Stable disease (SD) for >=30 days, without steroid use (or stable steroid dose established for >=14 days before the first dose of TAK-931).
Participants receiving corticosteroids who have not been on a stable dose for at least 7 days prior to study drug administration.
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment; eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
Patients requiring steroids must be at a stable or decreasing dose for at least 1 week prior to enrollment
Be medically stable
Increasing corticosteroid dose in 7 days prior to administration of first dose of study drug. Symptomatic patients who have stable or decreasing corticosteroid use in the past 7 days may be included
Patients with treated supratentorial metastases are allowed if stable, the patient is off steroids or on a stable or decreasing dose of =< 10 mg daily prednisone (or equivalent) and no evidence of intracranial hemorrhage
Presence of brain metastases (unless they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to enrollment provided patient is neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to enrollment)
If applicable, stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
Must be on stable doses of any drugs affecting hepatic drug metabolism or renal drug excretion (e.g. non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates, diphenylhydantoin, narcotic analgesics, probenecid). Such drugs should not be initiated less than 30 days prior to Baseline/C1D1 or at any time during study participation. Whenever possible, narcotic analgesic doses should be stable within 30 days prior to study entry and during the first cycle of therapy.
Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration
Anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of anticoagulant for > 2 weeks at time of randomization; for patients on therapeutic anti-coagulants, medication must be clinically held peri-procedure (bone marrow aspirate) per standard clinical management
Active brain metastases (e.g. stable for < 4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before registration)
Stable or decreasing steroid dose (=< 4 mg/day) at time of post-external beam radiation therapy (XRT) adjuvant TMZ initiation; if patients are decreasing steroid use, once they are at 2 mg/day, they may be supplemented with hydrocortisone, at the discretion of the treating oncologist
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for >1 month , are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. Stability of brain metastases must be confirmed with imaging. Subject treated with gamma knife therapy can be enrolled 2 weeks post-procedure as long as there are no post-procedure complications/they are stable. This criterion does not apply to subjects with GBM cohort. In Part 1, subjects with GBM may enroll provided that they are on a stable to decreasing dose of corticosteroids for at least 14 days prior to the first dose of GSK3326595. In Part 2, subjects with GBM may enroll irrespective of steroid dose.
UROTHELIAL CARCINOMA EXPANSION COHORT: Bisphosphonates and denosumab are permitted if on a stable dose for >= 4 weeks
Another cancer that is not clinically stable
Currently on the following concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study drug(s); the use of the following medications should be discontinued prior to initiation of protocol therapy and should be avoided during protocol therapy if reasonable alternatives exist\r\n* Sorafenib\r\n* Irinotecan\r\n* Corticosteroids: Patients requiring corticosteroids that have not been on a stable or decreasing dose of corticosteroid for 7 days prior to enrollment are not eligible
Patients with a history of central nervous system metastasis are allowed provided they have been treated (i.e., surgery, radiation, and/or radiosurgery) at least 4 weeks prior to registration and have stable neurologic function, including no requirement for medication(s) to control symptoms for at least 2 weeks; patients with known leptomeningeal disease are not eligible; NOTE: Stable low dose dexamethasone allowed at discretion of protocol chair
If receiving corticosteroids, patients must be on a stable or decreasing dose of corticosteroids for ? 5 days prior to baseline MRI.
If patients are taking systemic therapy for cGVHD at the time of enrollment, they must be receiving stable or tapering doses within the previous 4 weeks; patients are not required to have completed a course of steroids prior to enrollment
If patient is on steroids, patient must be on a stable or decreasing dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day at the time of screening and consent; if on steroids at the time of screening, the dose will need to be tapered and discontinued at least 5 days prior to CMV T cell infusion
PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: A baseline brain MRI must be obtained no more than 14 days (+ 3 working days) prior to study enrollment; the patient must either be on no steroids or a stable dose of dexamethasone no greater than 2 mg a day for at least 5 days prior to entrance onto the study
PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: A baseline brain MRI obtained no more than 14 days (+ 3 working days) prior to study enrollment on a stable dose of steroids no greater than 2 mg a day of dexamethasone for at least 5 days, is required prior to entrance of a patient onto the study; patients must be registered on the study within 5 weeks of completion of concurrent chemoradiation
Stable and/or decreasing dose of corticosteroids for greater than or equal to 7 days.
Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
Subjects with clinically apparent arrhythmia, or arrhythmias that are not stable on medical management within 2 weeks of the screening/enrollment visit
Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
CAPMATINIB EXCLUSION CRITERIA: Patients on unstable or increasing doses of corticosteroids; if patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms other than CNS related, dose must have been stabilized or decreasing for at least 5 days before first dose of capmatinib
CERITINIB EXCLUSION CRITERIA: Known symptomatic brain metastases or on unstable/increasing doses of steroid\r\n* Patients with asymptomatic brain metastases may be enrolled at the discretion of the sponsor as long as the patient is stable or has received treatment by a focal approach for brain metastases (e.g., radiation at least 2 weeks prior to starting ceritinib, or fully healed from neurosurgery)\r\n* Patients requiring seizure prophylaxis must be taking non-enzyme-inducing anti-epileptic drugs (non-EIAED); if patients were previously on EIAEDs and these have been discontinued, they must be discontinued for at least 1 weeks prior to capmatinib administration; if patients require an antiepileptic medication, then a CYP3A4 non-EIAED can be used such as levetiracetam, valproic acid, gabapentin, topiramate or lacosamide\r\n* Moderate inducers of CYP3A, CYP3A4, or CYP3A4/5 such as dexamethasone or other glucocorticoids may be used at the discretion of the Investigator; patients requiring steroid must be at a stable or decreasing for at least 5 days prior to study drug administration
For subjects on corticosteroids, they must be on a stable dose for 7 days prior to anticipated start of study drug
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before the first dose of study treatment; eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
Subjects who are receiving corticosteroids must be on a stable or decreasing dose for at least 4 weeks before first dose of study treatment.
For subjects with ATRT only, subject must have seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 21 days prior to the planned first dose of tazemetostat
Stable neurologic deficits on a stable dose of corticosteroids (if applicable) for at least 1 week before study enrollment
At the time of study enrollment patients must have a life expectancy of greater than or equal to 2 months; neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment
If receiving eltrombopag or romiplostim, the dose must have been stable for ? 21 days prior to the first dose of PRTX-100
If on steroid-sparing adjunctive immunosuppression with cyclosporine, azathioprine, mycophenolate, or 6-mercaptopurine, the dose must have been stable for ? 30 days prior to the first dose of PRTX-100 and must be expected to remain stable through study Day 29, unless dose reduction is required due to toxicities. Treatment with other cytotoxic agents (e.g. cyclophosphamide, vincristine) are not allowed within three months prior to the first dose of PRTX- 100.
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible.
Steroids: patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior enrollment in the study
Neurologic deficits must have been relatively stable for a minimum of 1 week prior to study enrollment
Patients receiving erythropoietin (darbepoetin, epoetin alfa) must be on a stable dose and with stable transfusion requirement or hemoglobin level during the 8 weeks prior to study entry
Hgb < 10.0 g/dL (unless the hemoglobin value has been stable, the subject is cardiovascularly stable, asymptomatic and judged able to withstand the RFA procedure) Note: If clinically indicated, subjects may receive platelets or packed red blood cell (RBC) transfusions and be re-evaluated after condition is treated.
Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic or untreated or not stable for >= 4 weeks (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks
Patients with a history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors, such as schwannoma, acoustic neuroma, or ependymoma only if those lesions have been stable for the past 6 months
Patients must be on stable dose of steroids for at least 5 days prior to baseline imaging
Patients must be maintained on a stable or decreasing corticosteroid regimen from the time of their baseline scan until registration
Patients who receive treatment with antiepileptic medications must have a two week history of stable dose of antiepileptic without seizures prior to dosing
Patients with corticosteroid requirements to control cerebral edema must be maintained at a stable or decreasing dose for a minimum of two weeks without progression of clinical symptoms
Currently taking cytotoxic chemotherapy; however, patients receiving non-investigational hormone therapy, lapatinib, and/or trastuzumab are eligible provided these medicines are at a stable dose and were begun more than 30 days prior to the first IT injection
Fixed or decreasing dose of corticosteroids (or no corticosteroids) for at least 1 week prior to cycle 1 day 1
Patients must have stable topical medication regimen for 2 weeks prior to study initiation
Patients must either not be receiving steroids, or be on a stable dose of steroids for at least five days prior to registration
Patients with neurological deficits should be stable for a minimum of 1 week prior to enrollment
If patient is on corticosteroids, the dose must be stable or decreasing for at least 5 days prior to enrollment
The use of anti-convulsants is allowed, as long as the patient is on a stable dose with no seizure activity for at least 2 weeks prior to initiating trial therapy
Have brain metastases that are neurologically unstable or require an increasing dose of corticosteroids. Patients must be on a stable or decreasing dose of corticosteroids for 7 days prior to first dose of AP32788.
If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.
Patients with neurological deficits should have deficits that are stable or improving for a minimum of 1 week prior to registration
Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to registration
PART II; Subjects must have been enrolled in Part 1 of this study and have received 1 dose of HSV1716 and have completed at a minimum the day 28 follow-up; subjects must have been categorized at a minimum as having stable disease thought to be attributable to the virus; subjects who were minimally characterized as having stable disease are also eligible if their lesion re-occurs or re-grows; the same criteria will be applied to determine eligibility for a third dose, and again for a fourth dose
Inclusion Criteria:\n\n        Patients must meet all the following inclusion criteria to be eligible for enrollment into\n        the study:\n\n          1. Age ? 18 years;\n\n          2. Life expectancy > 12 weeks;\n\n          3. Present with histologically confirmed intracranial (supratentorial) unmethylated MGMT\n             promotor status GBM (WHO Grade lV astrocytoma) with a MGMT status that has been\n             confirmed by validated PCR or validated alternate genomic analysis;\n\n          4. Have undergone maximal surgical resection of their tumor and within 6 weeks of surgery\n             received initial treatment with XRT/TMZ which consisted of XRT by external beam to a\n             partial brain field in daily fractions of 2.0 Gray (Gy), to a planned total dose to\n             the tumor of 60.0 Gy, in conjunction with TMZ oral QD 75 mg/m2 in accordance with the\n             Stupp regimen;\n\n          5. Must have measurable disease, according to RANO criteria for inclusion in the\n             expansion cohort. Patients with non-measurable disease can be included in the\n             dose-escalation cohorts;\n\n          6. KPS ? 70;\n\n          7. Cranial magnetic resonance imaging (MRI) must have been performed within 7 days prior\n             to or on the day of the Randomization/Week 1 Visit;\n\n          8. Stable or decreasing corticosteroid dose within 7 days prior to the first dose;\n\n          9. Adequate bone marrow/hematological function within 7 days prior to Day 1;\n\n         10. Adequate liver and renal function within 14 days prior to Day 1;\n\n         11. International normalized ratio (INR) or prothrombin time (PT) (secs) and activated\n             partial thromboplastin time (aPTT) within 7 days prior to randomization:\n\n         12. Patients must be willing to forego other drug therapy against the tumor while enrolled\n             in the study.\n\n        Exclusion Criteria:\n\n          1. Previous radiotherapy to the brain or cytotoxic drug therapy (including Gliadel®\n             wafers) in addition to the required postoperative radiation plus TMZ, non-cytotoxic\n             drug therapy, or experimental drug therapy directed against the brain tumor prior to\n             this regimen, will be excluded. Patients may have received or be receiving\n             corticosteroids, analgesics, and other drugs to treat symptoms or prevent\n             complications but the dose must be stable at treatment start. NOTE: 5 aminolevulinic\n             acid-mediated photodynamic therapy administered prior to surgery to aid in optimal\n             surgical resection is not considered a chemotherapy agent;\n\n          2. Any prior or anticipated concomitant treatment involving a medical device (such as\n             Optune®) applying tumor treating fields (TTF);\n\n          3. QT interval time of ? 470 msec;\n\n          4. Undetermined/indeterminate MGMT status;\n\n          5. Diabetic patients; prediabetic patients treated with metformin;\n\n          6. Use of any CYP3A4 inducing or inhibiting agents;\n\n          7. Significant medical illnesses;\n\n          8. Women who are pregnant or who are lactating;\n\n          9. Diagnosed with infratentorial GBM, a tumor outside of brain or gliomatosis cerebri;\n\n         10. Evidence of recent hemorrhage on postoperative MRI of the brain;\n\n         11. Any previous malignancy; except for adequately controlled limited basal cell carcinoma\n             of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix, or one\n             which has been absent for ?3 years;
Corticosteroids: Participants receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to study drug administration (except when indicated for Central Nervous System [CNS] metastases, then participants must not have received corticosteroids for at least 28 days)
If patient is receiving steroids, must be on stable or decreasing steroid dose within 5 days prior to treatment initiation with SGT-53.
Must be maintained on a stable or decreasing corticosteroid regimen (no increase for 7 days) prior to the start of treatment
Patients with untreated brain metastases are excluded; however, patients with metastatic central nervous system (CNS) tumors may participate in this trial, if the patient is > 4 weeks from therapy completion (including [incl.] radiation and/or surgery), is clinically stable at the time of study entry and has been on a stable dose of low dose steroids (=< 2 mg decadron per day) for at least 2 weeks
Have at least stable disease, as determined by the investigator.
Symptomatic metastatic brain or meningeal tumors unless the patient is >6 months from definitive therapy, has no evidence of tumor growth on an imaging study and is clinically stable with respect to the tumor at the start of study treatment. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
Patients receiving therapeutic non-Coumadin anticoagulation are eligible, provided they are on a stable dose (per investigator judgment) of anticoagulant
Any documented history of autoimmune disease with exception of Type 1 diabetes on stable insulin regimen, hypothyroidism on stable dose of replacement thyroid medication, vitiligo, or asthma not requiring systemic steroids.
Patients with treated stable CNS metastases that are asymptomatic (including leptomeningeal carcinomatosis) are allowed, if there is no evidence of progression for at least 4 weeks after CNS-directed treatment as ascertained by clinical examination and brain imaging. Patients requiring steroids must be at a stable or decreasing dose (?10 mg/day dexamethasone or equivalent) for at least 2 weeks prior to the start of treatment. The use of seizure prophylaxis is allowed.
Stable dose of corticosteroids for CNS metastasis for > 7 days
The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted.
RENAL COHORT: Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before the first dose of study treatment; eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment; eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
Stable or decreasing dose of steroids for at least 5 days at the time of baseline brain MRI.
Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
Patients requiring escalation of the corticosteroid dose will be excluded, but patients receiving a stable or decreasing dose for at least one week will be eligible
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Neurologic status\r\n* Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment\r\n* Patients with seizure disorders may be enrolled if seizures are well controlled
Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the baseline MRI
Clinically stable CNS tumor at the time of screening untreated or without evidence of progressions for at least 4 weeks after treatment as determined by clinical examination and brain imaging (MRI or CT) during screening period and stable low dose of steroids for 2 weeks prior to initiating study treatment
Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the baseline MRI
The subject requires dexamethasone =< 4 mg daily on a stable dose
Patients with a history of central nervous system (CNS) metastases must have documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids
Concurrent somatostatin analogues are allowed provided that the dose has been stable (+/- 10 mg) for at least 8 weeks
Leptomeningeal or brain metastases or metastases causing spinal cord compression that are symptomatic or untreated or not stable for >= 3 months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks
Stable topical steroid therapy with dexamethasone, clobetasol, or budesonide oral solutions (5 min, four times a day) for seven days prior to study enrollment
Baseline MRI within 17 days of Day 1 & on steroid dosage that has been stable or decreasing for at least 5 days
Patients must have stable disease at the time of enrollment
Patients who were receiving corticosteroids have to receive a stable or decreasing dose for at least 14 days before study entry
If corticosteroids are required for controlling cerebral edema, patients must be on a stable dose of at least 1 week prior to enrollment
History of symptomatic metastatic brain or meningeal tumors unless the subject is > 3 months from definitive therapy and has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry; subjects with brain metastases must not be undergoing acute corticosteroid therapy or steroid taper; chronic steroid therapy is acceptable provided that the dose is stable for one month prior to screening
Patients must be neurologically stable and with stable dose steroids and anticonvulsants for at least 1 week prior to obtaining the baseline MRI of the brain, and/or at least 1 week prior to beginning study treatment
Documentation of steroid doses 10-14 days prior to study registration and stable or decreasing steroid dose over the week prior to registration
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible
Patients who are receiving dexamethasone must be on a stable dose for at least 1 week prior to study entry
Patients must have no clinical evidence of active brain metastasis; patients with a history of brain metastases must have had them treated greater than 4 weeks previously with the central nervous system (CNS) lesions confirmed to be stable or regressing on imaging since the time of the last CNS treatment; patients will be evaluated with a head CT or MRI within 4 weeks of enrollment; patients must have no residual neurologic symptoms while taking either no steroids or a stable dose of steroids for the 2 weeks prior to enrollment; patients are allowed to be on a stable dose of anti-seizure meds
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible
Concomitant medications restrictions:\r\n* Growth factor(s): Must not have received within 7 days of entry onto this study\r\n* Steroids: Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 7 days\r\n* Study Specific: Patients must not be currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), clopidrogel, dipyridamole or aspirin therapy > 81 mg/day
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 days are not eligible
For subjects with CNS involvement: Subjects must have deficits that are stable for a minimum of 14 days prior to enrollment, or seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 7 days prior to enrollment NOTE: Subjects with leptomeningeal disease or brian tumors with positive cerebral spinal fluid cytology are eligible for this study. Subjects may receive glucocorticoids (at stable or tapering dose) to control CNS symptoms prior to enrollment; however, subjects should receive a stable or tapering dose for at least 7 days prior to enrollment.
Cohort A (asymptomatic): Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy within 10 days prior to first treatment. Cohort B (symptomatic): Subjects with neurologic signs and symptoms related to metastatic brain lesions are eligible per Amendment 02. Subjects with neurologic signs and symptoms may be treated with a total daily dose of no more than 4 mg of dexamethasone that is stable or tapering for 10 days prior to first treatment. Subjects with neurologic signs and symptoms who are not being treated with steroids are eligible for Cohort B and should have no experience of seizure within 10 days prior to first treatment.
Participants receiving bisphosphonate or denosumab therapy must have been on a stable dose for at least 4 weeks
Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids.
Stable systemic disease
Participant must have received ruxolitinib therapy for at least 24 weeks and be currently on a stable dose of >= 10 mg BID of ruxolitinib for >= 8 weeks prior to the 1st dose of navitoclax, ECOG of 0,1, or 2.
Stable or decreasing dose of corticosteroids within 5 days prior to study 5. enrollment.
Concurrent use of iron-chelating agents, (except for subjects on a stable or decreasing dose for at least 8 weeks (56 days) prior to randomization), corticosteroid (except for subjects on a stable or decreasing dose for ? 1 week prior to randomization for medical conditions other than MDS)
Subject received bisphosphonates or denosumab within 2 weeks prior to day 1 unless administered at stable dose or to treat diagnosed osteoporosis
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. NOTE: Subjects previously treated for these conditions that have had stable central nervous system disease (verified with consecutive imaging studies) for >1 month, are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. Stability of brain metastases must be confirmed with imaging. Subject treated with gamma knife the can be enrolled 2 weeks post-procedure as long as there are no post-procedure complications/stable. In addition, subjects treated or currently taking enzyme-inducing anticonvulsant are allowed on study.
If taking hormonal therapy, use should be stable (no changes within 4 weeks prior to the cryoablation procedure)
Patient must be on a stable dose of octreotide (Sandostatin) long-acting release (LAR) or lanreotide for 3 months prior to study enrollment
Subjects with a history of seizures must be on a stable dose of anti-epileptic drugs (AEDs) and without seizures for 14 days prior to enrollment in patients enrolled prior to Amendment 2. Subjects enrolled after Amendment 2 is approved with a history of seizures must be on a stable dose of anti-epileptic drugs (AEDs) for 7 days prior to enrollment.
Co-medication that may interfere with study results, e.g., immuno-suppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the Investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to first dose of MRZ.)
Concomitant medications: patients receiving anticoagulation should be on stable dose 2 weeks prior to registration
Other ongoing anti-myeloma therapy. Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids for symptom management and comorbid conditions. Doses of corticosteroid should be stable for at least 7 days prior to patient registration.
Stable dose of glucocorticoids pre-therapy. If patients are receiving glucocorticoids, the dose should not increase during the 96 hours prior to initiation of therapy.
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Participants requiring anti-diabetic medications must be on a stable dose and regimen for >=4 weeks
Neurologically stable defined as receiving no, stable, or tapering doses of corticosteroids for >= 5 days prior to drug dosing; treatment with corticosteroids during the study is allowed, and can be adjusted by the investigator during the study; changes in steroid dose are incorporated into the Revised Assessment in Neuro-Oncology (RANO) imaging criteria
Patients using oral or parenteral anticoagulation are not excluded provided they are on a stable dose of anticoagulant
Patients taking ruxolitinib at the time of enrollment must have been taking ruxolitinib for a minimum of 3 months, and must have been on a stable dose of ruxolitinib for a minimum of 4 weeks immediately prior to enrollment
Tumor-related pain increased above baseline for 2 weeks and not controlled by a stable dose of opiates
Uncontrolled endocrine disorder. Patients who are on endocrine replacement therapy must be on a stable dose.
If receiving corticosteroids, patients must be on a stable or decreasing dose of corticosteroids for ? 5 days prior to baseline MRI.
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. NOTE: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for >1 months, are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. Stability of brain metastases must be confirmed with imaging. Subject treated with gamma knife therapy can be enrolled 2 weeks post-procedure as long as there are no post-procedure complications/stable. In addition, subjects treated or currently taking enzyme-inducing anticonvulsant (EIAC) are allowed on study.
Stable supplement usage for > 2 weeks prior to starting and agrees not to change while on this study
No active brain metastases (e.g. stable for < 4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before treatment); no leptomeningeal disease
Stable or decreasing dose of corticosteroids prior to treatment with a goal of 4 mg or less of dexamethasone
Patients must be on a stable or decreasing dose of corticosteroids for 5 days prior to enrollment; patient may be taking therapeutic doses of steroids during the initial dose escalations and prior to defining an RP2D; this should be recorded in the database; once the RP2D has been established, enrollment may be limited based on steroid use;*physiologic replacement doses will be defined on this protocol as no more than 0.75 mg/m^2/day of dexamethasone or equivalent of steroids; doses higher than this will be considered therapeutic
Stable prescription of analgesic regimen during the 2 weeks prior to randomization.
Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of randomization and is clinically stable with respect to the tumor at the time of randomization; note: patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
Stable dose of corticosteroids for 4 weeks prior to enrollment; exception permitted with overall principal investigator (PI) approval
Patient has uncontrolled or severe intercurrent medical condition (including uncontrolled brain metastases). Patients with stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants are allowed provided there is no dose change within 4 weeks before the first dose of PBI 05204, and no anticipated dose change during study participation.
Stable dose of glucocorticoids for 4 weeks prior to enrollment
Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and have been stable for at least three months prior to registration; eligible subjects should be neurologically asymptomatic; there is no magnetic resonance imaging (MRI) evidence of progression for a minimum of 4 weeks after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Diabetics on insulin or antihyperglycemics must be on a stable dose (i.e., no titrations within the last 2 weeks) at the time of study entry
Diabetics on a stable dose of insulin or antihyperglycemic regimen are allowed if they have had no prior seizures and no history of loss of consciousness due to hypoglycemia
Patients with “treated and stable” brain lesions of a duration of >= 2 months may be enrolled
Patients must be on a stable or decreasing dose of corticosteroids for a minimum of 5 days before the baseline MRI/CT; if the corticosteroid dose is increased between the date of imaging and the initiation of study treatment, a new baseline MRI/CT is required; definition of stable steroids includes patients on no steroids
Subjects must be neurologically stable for at least 14 days prior to first dose of study drug;
Subjects with radiographically stable Central nervous system (CNS) metastases, defined as radiographically stable on the previous 2 brain imaging scans, asymptomatic, and off systemic steroids and anticonvulsants for at least 1 month are eligible; treatment with prophylactic anticonvulsants is permitted unless listed under Prohibited Medications
Note: Subjects with radiographically stable CNS metastases are defined as radiographically stable on the previous 2 brain imaging studies, asymptomatic, and off systemic steroids and anticonvulsants for at least 1 month; treatment with prophylactic anticonvulsants is permitted unless listed under prohibited medications
Diabetics on insulin or antihyperglycemics must be on a stable dose (i.e., no titrations within the last 2 weeks) at the time of study entry
Receiving baseline systemic glucocorticoid therapy (at stable dose) for cGVHD at study entry.
Patients currently receiving bone loss prevention treatment (e.g. bisphosphonates, denosumab, etc.) must be on a stable dose for at least 4 weeks prior to starting study treatment
If receiving myelofibrosis therapy, must be on a stable dose of the same regimen for at least 2 weeks prior to screen date and through the screening period
Subjects with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including those used to control symptoms, within 2 months of first dose. Subjects with glioma who are on a stable, steroid dosing regimen 5 days prior to the screening MRI may be permitted to enroll with Medical Monitor approval.
Patients on steroids for symptom management must be on a stable dose for 7 days prior to start of treatment
For those patients in which steroids are clinically indicated, there must be a stable or decreasing dose of steroid medication for >= one week prior to the start of infusion
Patients must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within 2 weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of olaparib dosing.
Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
Presence of brain metastases (except for subjects in the WHO Grade 1 or 2 or 3 or 4 glioma histology cohorts) that are symptomatic or untreated or not stable for >=3 months (must be documented by imaging) or requiring corticosteroids. Subjects on a stable dose of corticosteroids >14 days and have not required treatment with enzyme-inducing anticonvulsants for >30 days prior to enrollment can be enrolled with approval of the Medical Monitor
Stable dose of non-corticosteroid immunosuppressants for the 2 weeks prior to first dose of AMG 592.
Patients with “treated and stable” brain lesions of a duration of >= 2 months may be enrolled
Corticosteroids: If used to modify immune adverse events related to prior therapy, ?14 days must have elapsed since last dose of corticosteroid. Participants receiving corticosteroids, who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment, are not eligible
Patients receiving bisphosphonate therapy or denosumab must have been on a stable dose for at least 4 weeks prior to enrollment
Participants may have had up to two previous cytotoxic therapeutic regimens provided these were discontinued >= 4 weeks before enrollment; the use of antineoplastic agents for non-cancer therapy (i.e. colitis, rheumatoid arthritis) may be allowed provided the patient has been on a stable dose without toxicities greater than grade 1
Brain metastases that are symptomatic or untreated or not stable for >= 3 months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off enzyme-inducing anticonvulsants for > 4 weeks
Patients must have been on a stable dose of corticosteroids >= 5 days prior to obtaining their baseline gadolinium (Gd)-MRI of brain
Patients must be on a stable or decreased dose of steroids for at least 5 days prior to baseline imaging
Patients with NF (neurofibromatosis) are eligible, and may have other stable central nervous system (CNS) tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size for the preceding 6 months
Patients taking a cholesterol-lowering agent must be on a single medication and on a stable dose for at least 4 weeks
Any neurologic deficits must be stable for >= 1 week
Neurologic deficits that are rapidly progressing: all neurologic signs and symptoms must have been stable for a week prior to first dose
Symptomatic metastatic brain or meningeal tumors unless the patient is > 3 months from definitive therapy, has a negative imaging study within 4 weeks of irinotecan initiation, and is clinically stable with respect to the tumor at the time of study entry; also, the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to day 1 [D1] of treatment under this study)
Concurrent somatostatin analogues are allowed provided that the patient \r\n* Has been on a stable dose (+/- 10mg) for 8 weeks and \r\n* Has documented disease progression on that dose
Concurrent use of sargramostim (GM-CSF); filgrastim (G-CSF) could be used for the short-term management of neutropenic infection; stable doses of erythropoietin stimulating agents that were started > 8 weeks from first ruxolitinib dose or corticosteroids that were being administered prior to screening are allowed
Patients with uncontrolled brain metastases; patients who are on a stable dose of corticosteroids for more than 1 month or off corticosteroids for 2 weeks prior to study enrollment can be enrolled; enzyme-inducing anti-epileptic drugs are not permitted
Clinically stable and off corticosteroids for at least 4 weeks prior to study enrollment
Except for steroid refractory or intolerant cases, participants must be receiving baseline systemic glucocorticoid therapy for cGVHD at study entry; the dose of steroids must be stable for 14 days prior to starting study drug
Patients must be on a stable or decreasing dexamethasone dosage for at least 1 week prior to baseline MRI
Neurological deficits must be stable on a fixed or decreasing dose of dexamethasone for >= 7 days before study enrollment
Steroids: patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to baseline MRI
Stable dose of glucocorticoids pre-therapy; if patients are receiving dexamethasone, the dose of dexamethasone should not increase during the 96 hours prior to initiation of therapy
Concurrent somatostatin analogues are allowed provided that patients 1) have been on stable doses x 8 weeks and 2) have documented disease progression on that dose
Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to the first infusion with ipilimumab
No increase in corticosteroid dose in the week prior to baseline brain imaging
Subjects with brain metastases are eligible providing they are neurologically stable (if systemic steroids are required, subjects should be stable on the lowest clinically effective dose, as steroids as they may interfere with the activity of ipilimumab if administered at the time of the first ipilimumab dose)
Patients should be asymptomatic for jaundice and ascites prior to day 1; pain symptoms should be stable
Patients who have been treated for at least two weeks with stable doses of corticosteroids to address conditions unrelated to their malignancy will be allowed to continue this treatment during enrollment on the current trial
Part B: For Part B dose-expansion: once a MTD has been established in part A, additional dose escalation will occur with subsequent dose escalation of carfilzomib; during the dose escalation of part B, patient (pt) must have at least 1 line of prior therapy and no limitations on prior therapy; patients who had prior clinical benefit/response to ARRY-520 or carfilzomib with a stable disease (SD) or better may be eligible for dose expansion of part B; dose expansion of part B will be patients who are carfilzomib sensitive
If patient is on dexamethasone, must be on stable or decreasing dose of dexamethasone for >= 7 days; if patient is on different glucocorticoid e.g., prednisone, must be converted to dexamethasone prior to enrollment
Brain metastases permitted in Arms C and D if:\r\n* CNS-directed treatment has been given\r\n** >= 4 weeks interval between whole brain radiation therapy and initiation of protocol-based therapy\r\n** >= 2 weeks interval between stereotactic radiosurgery or gamma knife (or equivalent) and initiation of protocol-based therapy\r\n* CNS disease has been clinically and radiographically stable for at least 4 weeks\r\n* In Arm C, if patient on glucocorticoids, must be on stable (4 weeks) dose of no more than 2 mg/day of dexamethasone or equivalent\r\n* In Arms B and D, no steroids are allowed
Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of FOLFIRI initiation, and is clinically stable with respect to the tumor at the time of study entry; also, the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
Hypertension must be well controlled on stable doses of medication for at least two weeks prior to enrollment
Is neurologically stable without the need for steroids for ?7 days before first dose of study treatment.
Use of aspirin (>325 mg/day) within 10 days prior to the first dose of study treatment. The use of prophylactic therapeutic anti-coagulants are allowed provided that INR or aPTT are within therapeutic limits (according to the medical standard of the enrollment institution) and patient has been on a stable dose of anticoagulants for at least two weeks prior to the first dose of study treatment.
For patients receiving bone-loss prevention treatment (e.g., bisphosphonates or denosumab), the patient must be on stable dose ?4 weeks prior to start of study drug.
Patients will be allowed to participate following single prior CNS treatment with stereotactic radiotherapy whole brain irradiation and stable without steroid requirement for ?2 months or following ?2 prior CNS treatments with stereotactic radiotherapy whole brain irradiation and stable without steroid requirement for ?4 months.
Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization
? 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
Stable brain metastases either treated or being treated with a stable dose of steroids/ anticonvulsants, with no dose change within 28 days prior to the first dose of study drug, will be allowed.
Any neurologic deficits must be stable for >= 1 week
Neurologic deficits that are rapidly progressing; all neurologic signs and symptoms must have been stable for a week prior to first dose
If on anticoagulation, participant must be on stable therapeutic dose prior to enrollment
Has brain metastasis, unless has completed definitive therapy, is not on steroids, has a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and does not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Active brain metastases (e.g. stable for < 4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomization)
Pain symptoms should be stable and should not require modifications in analgesic management prior to Cycle 1 Day 1.
Subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.
? 2 weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities
Three or more weeks have elapsed from the completion of previous treatment regimen and subjects must have recovered or be at a new stable baseline from any related toxicities.
? 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
Bisphosphonates and denosumab are permitted, if on a stable dose for >= 4 weeks
Baseline MRI must be performed after subject signs informed consent form (ICF), within 17 days of Day 1, & on steroid dosage that has been stable or decreasing for at least 5 days
Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration; this is to be documented at baseline
Patients with central nervous system (CNS) tumors who are receiving dexamethasone must have been on a stable or decreasing dose of dexamethasone for the 7 days prior to enrollment
Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
Patients must have stable use of hormonal therapy for two weeks prior to cryoablation procedure)
Stable steroid dose in past 4 weeks
Patients must have no residual neurologic symptoms while taking no steroids, a stable or decreasing dose of steroids, or a stable dose of anti-seizure medication for the 2 weeks prior to enrollment.
Hepatitis B (HBV)-positive serology and is receiving interferon therapy or has liver function test results outside the parameters of study inclusion criteria. Other antiviral therapies are permitted if at a stable dose for at least 4 weeks.
Prior cytotoxic therapy for at least 4 weeks before treatment on study; treatment within this 4 week window with corticosteroids is permitted as long as the dose is stable or decreasing; radiotherapy within this 4 week window is permitted as long as it is completed prior to initiating therapy and as long as there is assessable disease for response outside of the radiation field
Patients who are not on a stable or decreasing steroid dose for the previous week prior to the first dose of study enrollment
Patients receiving hormonal therapy (i.e. any dose of megestrol acetate [Megace], Proscar [finasteride], any herbal product known to decrease PSA levels [e.g., Saw Palmetto and PC-SPES]) other than LHRH agonist/antagonist or a stable dose of corticosteroid from a prior chemotherapy regimen must discontinue the agent for at least 28 days prior to enrollment
If receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids and no more than 8 mg dexamethasone (or equivalent) for at least 5 days prior to date of enrollment.
Neurologically stable
Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 days
Participants with untreated central nervous system metastases, or history of previously treated disease. Participants must have stable hematological parameters, satisfying eligibility, platelet count must be stable for >=2 weeks prior to study drug administration
If a patient had been taking steroids, at least 2 weeks must have passed since the last dose; patients stable on physiologic replacement doses of steroids or other forms of hormone replacement therapy are eligible
Patients can be on steroids as long as the dose has been stable for >= 7 days
Individuals must have been on a stable dose of ruxolitinib for at least 4 weeks prior to study entry
Individuals on a stable ruxolitinib dose of 5 mg once daily
Subjects with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including to control symptoms, within 2 months of first dose. Subjects with glioma who are on a stable, steroid-dosing regimen prior to screening MRI may be permitted to enroll with Medical Monitor approval
Initiation of bisphosphonate therapy < 4 weeks prior to first dose of KPT-330; patients receiving bisphosphonate or denosumab therapy must be on stable doses for at least 4 weeks prior to first dose of KPT-330
Participants with stable enhancement/edema are eligible if they require corticosteroids to control symptoms
Known metastatic brain or meningeal tumors, unless the subject is >3 months from definitive therapy and clinically stable (supportive therapy with steroids or anticonvulsant medications is allowed) with respect to the tumor at the time of the first dose of study drug
Patients who are on a somatostatin analogue for control of hormonal syndromes must be on a stable dose (no change in mg dose of long acting octreotide or lanreotide, changes in dosing interval of +/- 1 week is allowed) for 2 months prior to date of study entry
At least 4 weeks post-craniotomy (7 days for stereotactic biopsy), within 14 days prior to the start of SL-701, and on a corticosteroid dosage that has been stable or decreasing for at least 5 days.
Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery and the disease has been confirmed stable (i.e., no increase in lesion size, and stable or decreased doses of corticosteroids) for at least 6 weeks with two consecutive scans prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3). (Enzyme inducing anticonvulsants are not allowed while subjects are on study treatment. Prior whole-brain radiation as adjuvant treatment is allowed.)
Stable or decreasing dose of corticosteroids for at least 7 days prior to randomization.
Patients must be on a stable dose of specific targeted therapy (erlotinib or crizotinib) for >= 28 days prior to initiation of ipilimumab/nivolumab
Neurological symptoms related to brain metastasis that are not controlled with a stable or decreasing dose of oral steroids for at least 7 days prior to starting GSK2118436
Patients with central nervous system (CNS) metastases will be allowed on this study. Patients may have received surgical and/or radiation treatment. The metastases must be neurologically stable, on or off corticosteroids. Patients can have low level, asymptomatic brain lesions that do not require surgical/radiation intervention acutely. Patients with symptomatic lesions with impending neurologic compromise should be appropriately treated with high dose steroids/radiation and may be re-evaluated for this study when neurologically stable.
Symptomatic metastatic brain or meningeal tumors unless the patient is > 3 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
Patients with known endocrine disorders including, but not limited to, Cushing's, or Addison's disease; stable diabetes mellitus and hypothyroidism, which have been managed with the same medications at stable doses for the last 6 months are permitted
Patients with histologically confirmed diagnosis of MB, who have experienced relapse or progression after standard-of-care therapy including radiotherapy. Patients currently receiving steroids must have been on a stable (or decreasing) dose for at least 5 days before initiating study therapy.
Patients receiving unstable or increasing doses of corticosteroids. If patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms, dose must have been stabilized (or decreasing) for at least 5 days before first dose of study treatment.
Subject receiving bisphosphonate or denosumab therapy must have been on stable doses for at least 4 weeks prior to Day 1
Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the start of treatment
Patients must be on a steroid dose that has been stable or decreasing for at least 5 days; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required
For patients on corticosteroids, they must have been on a fixed dose for 1 week prior to entry if clinically recommended
If patient has history of brain metastases, brain lesions should have been treated with surgery and/or radiation and be stable on repeat imaging and patients should be neurologically stable on a stable or tapering dose of corticosteroids
if receiving corticosteroids, dose is stable or decreasing for past 7 days
Subjects with brain metastases are excluded, unless a. All known lesions must be previously treated with surgery or stereotactic radiosurgery, and- b. Brain lesion(s), if still present, must be confirmed stable (i.e. no increase in lesion size) for ?90 days prior to first dose on study (must be documented with two consecutive MRI or CT scans using contrast), and c. Asymptomatic with no corticosteroids requirement for ? 30 days prior to first dose on study, and d. No enzyme-inducing anticonvulsants for ? 30 days prior to first dose on study.
INCLUSION CRITERIA:\n\n          -  Age: >/= 18\n\n          -  Diagnosis:\n\n               -  Histologically confirmed recurrent, locally advanced unresectable or metastatic\n                  adenocarcinoma of the pancreas who have progressed after front line chemotherapy,\n                  OR\n\n               -  Histologically confirmed metastatic colorectal adenocarcinoma who have progressed\n                  after at least 2 standard chemotherapy regimens.\n\n          -  Tumor sections must stain >/= 20% positive for NPC-1C antibody/antigen target\n\n          -  Measurable disease (by RECIST)\n\n          -  Karnofsky performance status of >/= 50%\n\n          -  Laboratory Function (within 21 days of receiving first dose of study drug):\n\n               -  Hemoglobin > 8.5 g/dL, or on stable doses (hematocrit stable within 1 gram and\n                  dose stable for one month) of erythropoietin or similar medication.\n\n               -  Absolute neutrophil count (ANC) >/= 1,500/mm3\n\n               -  Platelets >/= 50,000/mm3\n\n               -  Total bilirubin </= 2.0 mg/dL\n\n               -  ALT and AST </= 2.5 times the ULN, or, if the patient has liver metastases, </= 5\n                  times the ULN\n\n               -  Creatinine </= ULN\n\n          -  Voluntary written informed consent before performance of any study-related procedure\n             that is not part of normal medical care.\n\n          -  Expected to be able to remain on a study protocol for at least 8 weeks.\n\n          -  Is post-menopausal, surgically sterilized, or willing to use acceptable methods of\n             birth control for the duration of the study. Male subject agrees to use an acceptable\n             barrier method for contraception during the study.\n\n        EXCLUSION CRITERIA:\n\n          -  Has history of disseminated or uncontrolled brain metastases or central nervous system\n             disease.\n\n          -  Ascites with abdominal distention.\n\n          -  Mechanical, non-reversible reason for not being able to eat, or have a likelihood of\n             developing malignant bowel obstruction during the course of the induction phase of\n             treatment; subjects with uncomplicated J-tubes will not be excluded.\n\n          -  Any major surgery within four weeks of enrollment.\n\n          -  Uncontrolled concomitant illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac\n             arrhythmia.\n\n          -  Has another serious medical illness, including a second malignancy, or psychiatric\n             illness that could, in the Investigator's opinion, potentially interfere with the\n             completion of treatment according to this protocol.\n\n          -  Pregnant or breast-feeding.\n\n          -  Any chemotherapeutic agents or corticosteroids within 2 weeks of study entry or\n             biologic treatment within 4 weeks of study entry.\n\n          -  Use of any high risk medications that prolong the QT/QTc interval.\n\n          -  History of allergic reaction to Erbitux greater than grade 1.\n\n          -  Uncontrolled diabetes.\n\n          -  Prior history of a documented hemolytic event.\n\n          -  Receiving warfarin.
Their neurological function is stable for at least 30 days and either off steroid therapy or on a stable steroid regimen.
Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants). Dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation)
Neurologic deficits: Patients with central nervous system (CNS) tumors must have stable neurological deficits for a minimum of 1 week prior to study entry
Steroids: Dose should be stable or decreasing for at least one week prior to starting therapy; corticosteroid therapy is permissible only for the treatment of increased intracranial pressure in patients with malignancies in the CNS or for spinal cord compression; corticosteroid should be used at the lowest dose to control symptoms and discontinued if possible
Patients who have taken 5-alpha-reductase inhibitors (finasteride or dutasteride), saw palmetto, or PC-SPES within the last 6 weeks are ineligible for this study; patients taking other herbal supplements, vitamins, or other alternative medications are eligible for this study, as long as they were started > 2 months prior to study entry, have remained on a stable regimen, and will remain on a stable regimen for the duration of participation on this study
Stable dose of corticosteroid >= 14 days prior to registration
Must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI
Patients must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics
For patients with CNS tumors (primary or metastatic), any baseline neurologic deficits (including seizure) must be stable for at least one week prior to study enrollment
Patient must be maintained on a stable or decreasing dose of corticosteroid for at least 5 days before the baseline scan.
If patient is taking systemic therapy for cGVHD at the time of enrollment, they must be on a stable or tapering doses in the preceding 4 weeks
Concomitant medication as follows:\r\n* Subjects treated with gabapentin or other anticonvulsant for neuropathic pain will be required to taper the medication and discontinue for at least 2 weeks prior to study initiation\r\n* Patients on antidepressant treatment for pain or depression (tricyclic antidepressants [TCAs], selective serotonin reuptake inhibitor [SSRI], serotonin–norepinephrine reuptake inhibitors [SNRIs] etc.) will be allowed to continue their medications provided they have been on a stable dose for at least 4 weeks before study initiation; no dose regimen changes of antidepressants will be allowed during the study period\r\n* Patients on around-the clock opioid treatment (including tramadol) will be allowed to continue their medication provided they have been on a stable dose for at least 4 weeks before study initiation; the maximum allowed dose of opioid will be equivalent to 60 mg oral morphine sulfate; patients with higher doses will be required to taper down their opioid dose to maximum 60mg oral morphine equivalent, and continue on stable dose for 4 weeks before enrollment in the study; pro re nata (PRN) short-acting opioids for painful CIPN treatment will not be allowed; patients receiving PRN short-acting opioids (with or without acetaminophen) for pain other than CIPN will be allowed up to 4 daily doses, with daily recording of analgesic consumption\r\n* Treatment with nonsteroidal anti-inflammatory drug (NSAIDs) will be discontinued at least 2 weeks before study initiation; however, low-dose aspirin (=< 325 mg/day) will be allowed
Within 2 weeks prior to study enrollment the patient must be on a stable dose of medications for management of chemotherapy-induced peripheral neuropathy (CIPN) symptoms; for at least 2 weeks prior to enrollment stable dose is defined as: \r\n* No change in drug class \r\n* Increases or decreases that are less than or equal to 20% of the total dosage; all drug classes are allowed
On stable doses of any supplements or medications for six weeks prior to enrollment on the study
Patients who are receiving treatment with narcotics, tramadol, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to registration
Stable pain control defined as rescue doses =< 6 in last 24 hours
Subjects receiving ?2000 IU/day vitamin D (ergocalciferol or cholecalciferol) therapy must remain on a stable dose during the study. If taking more than 2000 IU/day of vitamin D (ergocalciferol or cholecalciferol), must be willing and able to reduce use to ?2000 IU/day and remain on a stable dose for the duration of the study
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before study enrollment; eligible subjects must be without corticosteroid treatment at the time of study enrollment
Stable dose of corticosteroids for 2 weeks prior to enrollment
Stable dose of glucocorticoids for 4 weeks prior to enrollment
Patients with “treated and stable” brain lesions of a duration of >= 2 months may be enrolled
Patients with no pain and with stable pain (defined as pain under control and on stable doses of opioids for 1 week) are eligible
Patients on stable doses (defined as same dose for 2 weeks) of dexamethasone, mirtazapine, zolpidem, benzodiazepines, phenothiazines are allowed to participate in the study
Patients taking concomitant diuretics or dihydropyridine class of calcium channel blockers must be on a stable daily dose for at least 6 months prior to enrollment
Stable dose of corticosteroids for treatment of GVHD for 2 weeks prior to enrollment (fluctuation of corticosteroids for treatment of anything other than GVHD acceptable)
Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Concomitant medications\r\n* Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol \r\n* Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol \r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible
FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: If patients are on immunosuppressive therapy for treatment of GVHD, then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligible
For patients on higher than physiological level of corticosteroids, they must have been on a stable dose for 1 week prior to initiating study drug, and the dose should not be escalated over entry dose level, if clinically possible
Patients on a stable (>= 4 week duration) dose of > 2000 IU/day (or equivalent) of vitamin D supplementation
Concurrent use of corticosteroids unless the subject is on a stable or decreasing dose for ? 1 week prior to enrollment for medical conditions other than MDS (MYELODYSPLASTIC SYNDROMES)
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Subject has been receiving ruxolitinib therapy for intermediate or high-risk myelofibrosis for >6 months prior to enrollment with no more than 1 dose reduction of ruxolitinib in the 2-8 weeks prior to enrollment and a stable daily dose ?5 mg twice daily (BID) >2 months prior to enrollment.
On a stable or decreasing dose of dexamethasone for the previous 7 days
Patients must not have been taking steroids or are on a stable dose of steroids for at least 14 days before enrollment
Patients receiving thiazides or furosemide diuretics, with the exception of subjects who have stable doses and have been on therapy for over six months
Medically stable as judged by patient’s physician
Patient must be maintained on a stable corticosteroid regimen for 5 days prior to each MR-PET scan
Patients on corticosteroids must be maintained on a stable corticosteroid regimen for 5 days prior each magnetic resonance (MR)-PET scan
Medically stable as judged by patient’s physician
Be clinically stable
Medically stable as judged by patient’s physician.
PATIENT: Be medically stable
Can be on androgen deprivation therapy if dose is stable for >= 1 week
Be medically stable.
Be medically stable
Receiving a stable dose of octreotide LAR as a part of a treatment regimen for >= 3 months
Patients receiving corticosteroids are eligible provided the dose is stable or decreasing for at least 7 days
Be medically stable
Be medically stable
Subjects with brain metastasis are acceptable if the clinical condition has been stable for at least one month; subjects who are on stable doses (as determined by the principal investigator) of steroids may enroll in the study
If does not have a stable place to live
Stable or decreasing dose of corticosteroids over 14 days prior to first MRZ dose
Subjects with a history of CNS metastases must have completed definitive treatment prior to first dose of study treatment, off or on a stable dose of corticosteroids
Patients with treated brain metastases are eligible if they are > 4 weeks from therapy completion (including radiation and/or surgery), are clinically stable at the time of study entry and are not receiving corticosteroid therapy at the time of study entry