Patients with untreated brain metastases, spinal cord compression, or leptomeningeal carcinomatosis should be excluded from this clinical trial; patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as brain images, both of which are obtained after treatment to the brain metastases; these imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression); in addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of =< mg/day of prednisone or its equivalent (and anti-convulsants) for at least days prior to the start of treatment
Have known symptomatic brain metastases requiring steroids. Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least weeks and have radiographically stable disease for at least months prior to study entry. Note: up to mg per day of prednisone equivalent will be allowed.
Patients with brain metastases treated with whole brain radiation that have been stable for months are eligible; patients with brain metastases treated with gamma knife or surgery are allowed to participate after weeks have elapsed since their procedure; demonstration of brain stability by an imaging study after the procedure is required for gamma knife or central nervous system (CNS) surgery patients; subjects are excluded if they have leptomeningeal or metastases causing spinal cord compression that are symptomatic or untreated or not stable for >= months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > month or who have been off of corticosteroids for at least week can be enrolled with approval of the medical monitor
Stable brain metastasis allowed (> weeks, clinically stable post treatment with surgery +/- radiation or radiation alone and off steroids)
CNS malignancy, the known presence of untreated or symptomatic CNS metastases. Subjects with treated brain metastasis must be stable and off steroids and anti-convulsants for at least month prior to the start of study treatment. Subjects with suspected brain metastases at Screening should have a CT/MRI of the brain prior to study entry.
Known untreated brain or leptomeningeal metastasis\r\n* Patients with brain metastases are eligible if metastases have been adequately treated and neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least two weeks prior to CD and meet requirements related to steroids
Leptomeningeal disease or uncontrolled brain metastasis\r\n* NOTE: Metastases treated by surgery and/or radiotherapy such that patient is neurologically stable and off steroids >= weeks prior to preregistration are eligible
Prior central nervous system (CNS) disease is allowed if stable for at least one month since whole brain radiation therapy, and weeks since stereotactic radiotherapy, and not requiring steroids; patients whose CNS disease was surgically treated may be enrolled if stable for at least one month, and not requiring steroids
Patients with symptomatic brain metastases; subjects with untreated brain metastasis =< cm can be considered eligible if deemed asymptomatic by the investigator upon consultation with the medical monitor and do not require immediate radiation or steroids; subjects with brain metastasis that is treated and stable for month may be considered eligible if they are asymptomatic and on stable dose of steroids or if they do not require steroids following successful local therapy
Stable brain metastases allowed (> weeks, clinically-stable post treatment with surgery +/- radiation or radiation alone and off steroids)
Patients with known brain metastases should be excluded from this clinical trial; however, patients with previously treated and stable brain metastases are eligible as long as they are no longer requiring steroids, completed radiation therapy more than weeks prior to the first dose of study regimen and have no seizures or worsening neurologic symptoms
If there is a known history of brain metastases, either treated with radiation therapy or untreated, the metastatic disease must be stable in the judgment of the Principal Investigator and must not require ongoing treatment with corticosteroids or anticonvulsants.
Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of weeks must have elapsed between the end of whole brain radiotherapy and study enrollment ( weeks for stereotactic radiotherapy).
Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= month after treatment of the brain metastases; patients on anti-seizure medications may be enrolled at the discretion of the principal investigator
Participants with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients with brain metastatic disease that has previously been treated and remained stable on MRI >= months prior to enrollment, without steroids or anti-epileptic medications. These patients may be enrolled at the discretion of the principal investigator.
Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and treated CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases > days prior to study entry including radiotherapy or surgery. Steroids for the treatment of brain metastasis are not permitted, and patients must be stable off steroid treatment for weeks prior to enrollment.
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 weeks
For part (dose escalation) only, patients with previously diagnosed brain metastases are eligible as long as they do not require central nervous system (CNS)-directed therapy (including corticosteroids); if the patient has had radiation therapy or surgery, then they should have completed treatment and have discontinued corticosteroids for at least weeks and must be neurologically stable; patients with brain metastases are excluded from part (dose expansion)
Known brain metastases or carcinomatous meningitis. Exception: previously treated brain metastatic disease that remains stable on MRI ? weeks prior to enrollment, without steroids or anti-epileptic medications
Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients with brain metastatic disease that has previously been treated and remained stable on MRI >= months prior to enrollment, without steroids or anti-epileptic medications; these patients may be enrolled at the discretion of the principal investigator
Symptomatic brain metastases; stable and treated central nervous system (CNS) disease allowed; patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least two () weeks prior to initiating study treatment; anticonvulsant therapy will be allowed if patient is on a stable or decreasing dose of anticonvulsant treatment for at least two () weeks prior to initiating study treatment
Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= month after treatment of the brain metastases; patients on anti-seizure medications or steroid therapy may be enrolled at the discretion of the principal investigator
Uncontrolled brain metastases (Stable brain metastases either treated or being treated with a stable dose of anticonvulsants, with no dose change within days before enrollment, will be allowed.).
Untreated brain metastases (pts with treated brain mets who are off steroids and anticonvulsants and stable for at least month at the time of Screening are eligible)
Patients with known untreated brain metastases; patients with known, treated brain metastases must be stable with no symptoms for four weeks after completion of that treatment, with image documentation required, and must either be off steroids or on a stable dose of steroids for at least two weeks prior to protocol enrollment; patients with known leptomeningeal metastases are excluded, even if adequately treated; patients without known brain metastases do not require radiologic imaging prior to enrollment
Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= month after treatment of the brain metastases; patients should not be on anti-seizure medications; these patients may be enrolled at the discretion of the principal investigator
Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least month off steroids.
Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients with treated brain metastases, whose brain metastatic disease has remained stable for >= weeks without requiring steroid and anti-seizure medications are eligible to participate
Patients with known active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients whose brain metastatic disease status has remained stable for >= weeks following treatment of brain metastases are eligible to participate at the discretion of the principal investigator
All subjects with brain metastases, except those meeting the following criteria:\r\n* Brain metastases that have been treated locally and are clinically stable for at least weeks prior to enrollment\r\n* No history of intracranial or spinal cord hemorrhage\r\n* No evidence of interim central nervous system (CNS) disease progression\r\n* Metastasis to the midbrain, pons, and medulla\r\n* No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable.\r\n* Subjects must be either off steroids or on a stable or decreasing dose of =< mg daily prednisone (or equivalent).
Untreated symptomatic brain metastases (treated brain metastases are allowed provided > days have elapsed from completion of radiotherapy and patient is neurologically stable as assessed by treating physician)
For patients with known and treated brain metastases is allowed in this study if they fulfill ALL of the following criteria:\r\n* The lesions have remained radiologically stable for at least six weeks after completion of brain irradiation or stereotactic brain radiosurgery, and must remain stable at the time of study entry\r\n* There is no mass effect present radiologically and no steroids requirement for symptom control for more than weeks
Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least weeks after completion of definitive treatment and within weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only)
Active brain metastases (e.g., stable for < 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 weeks before randomization otherwise no steroids to exceed prednisone mg/day prior to starting trial treatment; symptomatic or uncontrolled central nervous system (CNS) metastasis
Patients with treated and stable brain lesions of a duration of > weeks may be enrolled
Note: Patients with previously treated brain metastases may participate, weeks after gamma knife (or equivalent) or weeks after whole brain radiotherapy (WBRT), provided they are stable (without evidence of progression by imaging and have not been using steroids for at least days prior to study treatment
Has spinal cord compression or clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of weeks must have elapsed between the end of whole brain radiotherapy and study enrollment ( week for stereotactic radiotherapy).
Patients with clinically active brain metastases. However, patients with previously currently stable brain metastases on medication (i.e., steroids and/or anti-seizure medications) may be enrolled after consultation with the Medical Monitor.
Patients with previously untreated brain metastases should be excluded; patients with treated and stable (> weeks) brain metastases may be eligible for enrollment
All subjects with brain metastases, except those meeting the following criteria:\r\n* Brain metastases that have been treated locally and are clinically stable for at least weeks prior to enrollment\r\n* No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)\r\n* Subjects must be either off steroids or on a stable or decreasing dose of =< mg daily prednisone (or equivalent)
Documented brain metastases that are untreated, symptomatic, or require therapy to control symptoms; participants with previously diagnosed brain metastases are eligible if they have completed treatment at least one month prior to trial registration, are neurologically stable, and have recovered from effects of radiotherapy or surgery\r\n* Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= weeks before the first study drug\r\n* Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery, or a combination as was deemed appropriate by the treating physician\r\n* Patients who meet the above criteria and are clinically stable on anticonvulsant medication are eligible only if their anti-convulsant does not alter hepatic cytochrome P activity in a way that might interfere with metabolism of abemaciclib
Subjects with radiographically stable treated brain metastases are eligible but must not have been on steroid therapy for at least weeks
Primary brain tumors or known brain metastasis unless clinically stable and on stable or reducing doses of steroids.
Patients with known symptomatic brain metastases requiring systemic corticosteroids; patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least weeks and are neurologically stable; mild neurological deficit is allowed, if it does not interfere with the ability to judge the safety on the trial
Treated stable brain metastases are allowed, as long as patient does not require steroids or anti-seizure medications
Participants with history of brain metastases who have not shown clinical and radiographic stable disease for at least days after definitive therapy.
All subjects with brain metastases, except those meeting the following criteria:\r\n* Brain metastases that have been treated locally and are clinically stable for at least weeks prior to enrollment \r\n* No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)\r\n* Subjects must be either off steroids or on a stable or decreasing dose of =< mg daily prednisone (or equivalent)
Patients with clinically symptomatic brain metastases or who required treatment for brain metastases within weeks of registration (stable sequelae acceptable if treatment has been completed; these lesions cannot be used as target lesions)
Brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids
All subjects with brain metastases, except those meeting the following criteria:\r\n* Brain metastases that have been treated locally and are clinically stable for at least weeks prior to enrollment \r\n* No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)\r\n* Subjects must be either off steroids or on a stable or decreasing dose of < mg daily prednisone (or equivalent)
Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients with treated brain metastases, whose brain metastatic disease has remained stable for greater than or equal to weeks without requiring steroid and anti-seizure medications are eligible to participate
All subjects with brain metastases, except those meeting the following criteria: \r\n* Brain metastases that have been treated locally and are clinically stable for at least weeks prior to enrollment\r\n* No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)\r\n* Subjects must be either off steroids or on a stable or decreasing dose of =< mg daily prednisone (or equivalent)
Patients with previously treated (with radiation or surgery) brain metastases that are stable are allowed; patients with stable or progressing metastases must have metastases =< . cm, be asymptomatic, and either not be on steroids or be on mg prednisone equivalent or less
Brain metastasis allowed if previously treated, stable and off steroids for a minimum of days
Active brain metastases (e.g. stable for < 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)
Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for months are eligible
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 > month , are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least month prior to study Day are permitted. Stability of brain metastases must be confirmed with imaging. Subject treated with gamma knife therapy can be enrolled 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 , subjects with GBM may enroll provided that they are on a stable to decreasing dose of corticosteroids for at least days prior to the first dose of GSK. In Part , subjects with GBM may enroll irrespective of steroid dose.
PHASE I: Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least weeks and the patient is off steroids or is on a stable dose of steroids; patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within days before first dose and during study; use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed
PHASE II SCLC: Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least weeks and the patient is off steroids or is on a stable dose of steroids; patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within days before first dose and during study; use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed
Patients with treated and clinically stable brain metastases are allowed
Known active central nervous system (CNS) disease - If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery- patients should be neurologically stable and on a stable or tapering dose of corticosteroids
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 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 weeks prior to capmatinib administration; if patients require an antiepileptic medication, then a CYPA non-EIAED can be used such as levetiracetam, valproic acid, gabapentin, topiramate or lacosamide\r\n* Moderate inducers of CYPA, CYPA, or CYPA/ 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 days prior to study drug administration
Patients may have treated and stable brain metastases; they must be off steroids and must have had stable brain metastases for at least months
Known untreated brain or leptomeningeal metastasis\r\n* Patients with brain metastases are eligible if metastases have been adequately treated and neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least two weeks prior to CD
Patients with brain metastases. However, if radiation therapy and/or surgery has been completed and serial evaluation by CT (with contrast enhancement) or MRI over a minimum of one month demonstrates the disease to be stable and if the patient remains must have no need for treatment with steroids
Patients may be enrolled with a history of treated brain metastases that are clinically stable for >= weeks prior to start of study treatment
Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least months are eligible
Evidence of symptomatic brain metastases. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible, assuming the patient has adequately recovered from treatment
Symptomatic or history of untreated brain or leptomeningeal metastases; treated patients should be neurologically stable for weeks after completion of appropriate therapy; patients should be off steroids at least days prior to start of therapy on clinical trial
Have symptomatic central nervous system metastases. Patients with brain metastases that have been previously treated and are stable for ? weeks or treated with gamma knife surgery and are stable for ? weeks are allowed to enter the study.
Brain metastases, which are symptomatic; patients with treated, brain metastases are eligible with stable brain disease for at least weeks without the requirement for steroids or anti epileptic therapy
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 > 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 (=< mg decadron per day) for at least weeks
Patients with known brain metastases may be included in the study, providing they are clinically stable.
Patients with treated stable CNS metastases that are asymptomatic (including leptomeningeal carcinomatosis) are allowed, if there is no evidence of progression for at least weeks after CNS-directed treatment as ascertained by clinical examination and brain imaging. Patients requiring steroids must be at a stable or decreasing dose (? mg/day dexamethasone or equivalent) for at least weeks prior to the start of treatment. The use of seizure prophylaxis is allowed.
Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients with treated brain metastases, whose brain metastatic disease has remained stable for >= weeks without requiring steroid and anti-seizure medication are eligible to participate
Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients with treated brain metastases, whose brain metastatic disease has remained stable for >= weeks without requiring steroid and anti-seizure medication, are eligible to participate
Symptomatic central nervous system metastases; subjects with brain metastases that have been previously treated and are stable for weeks off steroids are allowed; patients must be stable off steroids for brain metastases for at least days; subjects with asymptomatic clinically insignificant brain metastases not requiring treatment are allowed; the exception does not include carcinomatosus meningitis which is excluded regardless of clinical stability
Has untreated CNS metastases and/or carcinomatous meningitis that meets RECIST criteria identified either on the baseline brain imaging obtained during the screening period or identified prior to signing the informed consent form (ICF); patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as brain images, both of which are obtained after treatment to the brain metastases; these imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of =< mg/day of prednisone or its equivalent and not requiring anticonvulsants for at least days prior to the start of treatment
Known brain metastases or CNS cancer unless adequately treated with radiotherapy and/or surgery and stable for ? mo
Clinically stable CNS tumor at the time of screening untreated or without evidence of progressions for at least weeks after treatment as determined by clinical examination and brain imaging (MRI or CT) during screening period and stable low dose of steroids for weeks prior to initiating study treatment
Participants with previous brain metastases are eligible provided that they are treated and asymptomatic not requiring steroids or anticonvulsants, and have stable disease at the screening tumor assessment; a week disease stable interval as confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) brain w/ contrast is required after treatment of brain metastases before initiation of thoracic radiation therapy; in addition, subjects must have been either off corticosteroids, or on a stable or decreasing dose of mg daily prednisone (or equivalent)
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 weeks after completion of definitive treatment and within weeks prior to first dose of study drug, off or on a stable dose of corticosteroids
Subjects with treated brain metastases are eligible provided the metastases are clinically stable and greater than weeks has elapsed from time of treatment and date of initiation of study drug
Patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= months after treatment of the brain metastases, without steroids or anti-seizure medications; these patients may be enrolled at the discretion of the principal investigator
Extensive active brain disease including symptomatic brain metastases or presence of leptomeningeal disease \r\n* NOTE: Patients with brain metastasis, after definitive therapy with surgery or stereotactic radiation and stable off steroids for >= weeks, are eligible
Patients with stable and controlled brain metastases for at least months who also do not require steroids
Patients with known brain metastases should be excluded from this clinical trial; previously treated brain metastases, neurologically stable, and no ongoing or anticipated need for steroid therapy are eligible
Patients must be neurologically stable and with stable dose steroids and anticonvulsants for at least week prior to obtaining the baseline MRI of the brain, and/or at least week prior to beginning study treatment
Patients with treated brain metastasis as long as neurologically stable and not on steroids for at least weeks
Patients with brain metastases may participate in this trial provided they are clinically stable; patients who are < month from definitive therapy, receiving steroid therapy or taper, or anti-convulsant medications (started for brain metastases) must not be included
Patients with known active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients whose brain metastatic disease status has remained stable for >= weeks following treatment of brain metastases are eligible to participate at the discretion of the principal investigator
Extensive active brain disease, including symptomatic brain metastases or the presence of leptomeningeal disease\r\n* Patients with brain metastasis, after definitive therapy with surgery or stereotactic radiation and stable off steroids for > weeks, are eligible
Study participants with brain metastases are excluded unless these have been definitively treated and are radiographically stable for at least month; the study participant must also demonstrate a stable physical exam and must have discontinued systemic steroids for treatment of edema related to brain metastases or treatment for over days
Patients must have no clinical evidence of active brain metastasis; patients with a history of brain metastases must have had them treated greater than 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 weeks of enrollment; patients must have no residual neurologic symptoms while taking either no steroids or a stable dose of steroids for the weeks prior to enrollment; patients are allowed to be on a stable dose of anti-seizure meds
Subjects with untreated or uncontrolled brain metastases or evidence of leptomeningeal disease; brain metastases that have been appropriately treated with radiation and/or surgery will be allowed as long as the central nervous system (CNS) disease has been stable for at least weeks post-treatment
Patients with known brain metastases may be enrolled if this site of disease has been adequately treated, the patient does not require steroids, and the patient has been stable for at least months prior to enrollment
Patients with a history of brain metastases are eligible if they have been treated with radiation and have stable brain metastases at least months after radiation and must also be off steroids
Patients with brain lesions that have been treated with whole brain radiotherapy and are clinically stable for at least weeks, are not taking steroids and are not receiving enzyme-inducing anticonvulsants will be eligible
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 weeks after completion of definitive treatment and within weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids.
Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ? weeks prior to first dose of study drug).
Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least weeks prior to study entry and are neurologically stable.
Known brain metastases or CNS cancer unless adequately treated with radiotherapy and/or surgery and stable by symptoms and radiographic imaging and not requiring corticosteroids for at least mo before randomization
Patients with clinically or radiologically unstable brain metastases are excluded from this clinical trial\r\n* Note: patients with stable brain metastases after treatment, for at least months prior to enrolling on this trial, could participate in the study; patients should be off, or on a stable dose of steroids
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 > month, are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least month prior to study Day are permitted. Stability of brain metastases must be confirmed with imaging. Subject treated with gamma knife the can be enrolled 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.
Any known untreated brain metastases. Treated subjects must be stable weeks after completion of treatment for brain metastases and image documented stability is required. Patients must have no clinical symptoms from brain metastases and must be either off of steroids or on a stable dose of steroids for at least weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated
CNS disease other than neurologically stable, treated brain metastases.
Any known, untreated, brain metastases. Treated subjects must be stable weeks after completion of treatment for brain metastases and image documented stability is required. Patients must have no clinical symptoms from brain metastases and have not required systemic corticosteroids > mg/day prednisone or equivalent for at least weeks prior to first dose of study drug.
Any signs and/or symptoms of brain metastases must be stable for ? weeks
Subjects with previously treated brain metastasis (es) that is asymptomatic or radiographically/clinically stable and not requiring steroids medications for weeks prior to enrollment are permitted.
Active brain metastases (e.g. stable for < weeks)
Brain metastases unless resected or irradiated and stable >= weeks
Active brain metastases (defined as neurologically stable for less than (<) weeks and/or symptomatic and/or requiring treatment with steroids and/or leptomeningeal disease) Subjects must have completed any prior treatment for brain metastases >= weeks prior to start of therapy (>= weeks for stereotactic radiosurgery/gamma knife). Subjects who are neurologically stable on symptomatic therapy with anticonvulsants with low drug interaction risk or whose steroids are being tapered are eligible. Asymptomatic untreated brain metastases less than or equal to (<=) cm of longest diameter are eligible
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 > months, are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least month prior to study Day are permitted. Stability of brain metastases must be confirmed with imaging. Subject treated with gamma knife therapy can be enrolled 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.
Untreated brain metastases. Participants must have completed treatment for brain metastasis, and be neurologically stable off steroids, for at least days prior to first dose of study drug
No active brain metastases (e.g. stable for < 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
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 weeks before the first dose of PBI , and no anticipated dose change during study participation.
Patients with asymptomatic brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids; maximum daily dose of steroids should be prednisone mg or equivalent; radiation therapy for brain metastases must be completed at least days prior to treatment on protocol
Patients with treated and stable brain lesions of a duration of >= months may be enrolled
Subjects with radiographically stable Central nervous system (CNS) metastases, defined as radiographically stable on the previous brain imaging scans, asymptomatic, and off systemic steroids and anticonvulsants for at least 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 brain imaging studies, asymptomatic, and off systemic steroids and anticonvulsants for at least month; treatment with prophylactic anticonvulsants is permitted unless listed under prohibited medications
If the patient has brain metastasis, they must have been stable (treated and/or asymptomatic) and the patient must have been off steroids for at least weeks
PHASE I: Participants with untreated or uncontrolled brain metastases are excluded from this clinical trial; patients with treated and stable (> weeks) brain metastasis are allowed
Any known untreated brain metastases. Treated subjects must be stable for weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
Participants with symptomatic brain metastases that require chronic steroids are excluded; patients with a history of brain metastases are permitted to enroll as long as they have been treated, off of steroids and have been stable for one month on imaging
Symptomatic brain metastasis or leptomeningeal disease requiring radiation therapy or escalating doses of steroids; patients with clinically stable brain metastases (previously treated or untreated) are eligible; patients in expansion cohort A must have at least one untreated central nervous system (CNS) lesion
Presence of brain metastases (except for subjects in the WHO Grade or or or glioma histology cohorts) that are symptomatic or untreated or not stable for >= months (must be documented by imaging) or requiring corticosteroids. Subjects on a stable dose of corticosteroids > days and have not required treatment with enzyme-inducing anticonvulsants for > days prior to enrollment can be enrolled with approval of the Medical Monitor
Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= months after treatment of the brain metastases; patients should be on stable doses of anti-seizure medications; these patients may be enrolled at the discretion of the principal investigator
Absence of brain metastases is not required. Patients must not have symptomatic brain metastatic disease. The patient may be symptomatically controlled on a stable dose of corticosteroids before and during the study as long as these were started at least weeks prior to treatment.
Patients with treated and stable brain lesions of a duration of >= months may be enrolled
Active brain metastases: participants with previously diagnosed brain metastases are eligible if they have completed treatment at least one month prior to enrollment, are neurologically stable, and have recovery from effects of radiotherapy or surgery
Patients with treated brain metastases that have been stable for month are eligible; patients must be off steroids for week prior to starting study treatment
Uncontrolled or symptomatic brain metastases that are not stable or require steroids, are potentially life-threatening or have required radiation within days prior to first dose of study treatment.
Patients with treated, stable brain metastases are allowed to enroll; patients must be at least weeks from brain radiation and off any medications used to treat brain metastases including steroids; patients are allowed to be on anti-epileptic medications that are not contraindicated
Patients with untreated brain metastases are excluded; however, patients with treated brain metastases are eligible if they are > 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
Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least month off steroids.
Any known untreated brain metastases. Treated subjects must be stable for weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
Known uncontrolled brain metastases. Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants
Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases must be stable for weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
Patients with stable brain metastases are eligible for this trial; stable brain metastases defined as stable disease for one month and not on active treatment including steroids
Known brain metastases, unless these metastases have been treated and stabilized for at least weeks, prior to enrollment in the study. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to randomization in the study.
Subjects with known untreated brain metastases; subjects with known, treated brain metastases must be stable with no symptoms for four weeks after completion of that treatment, with image documentation required, and must either be off steroids or on a stable dose of steroids for at least two weeks prior to protocol enrollment; subjects with known leptomeningeal metastases are excluded, even if adequately treated; subjects without known brain metastases do not require radiologic imaging prior to enrollment
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)
Brain metastases permitted in Arms C and D if:\r\n* CNS-directed treatment has been given\r\n** >= weeks interval between whole brain radiation therapy and initiation of protocol-based therapy\r\n** >= 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 weeks\r\n* In Arm C, if patient on glucocorticoids, must be on stable ( weeks) dose of no more than mg/day of dexamethasone or equivalent\r\n* In Arms B and D, no steroids are allowed
Unstable or symptomatic brain metastases (however, patients with stable or treated brain metastases who do not require steroids at doses above those permitted for control of symptoms may be enrolled)
Patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= months after treatment of the brain metastases, without steroids or anti-seizure medications; these patients may be enrolled at the discretion of the principal investigator
Participants with active brain metastases; stable treated brain metastases are allowed (this includes participants who have documented radiologic stability at least weeks after radiotherapy, and do not require systemic steroids for management of symptoms from central nervous system [CNS] metastatic lesions)
Patients with known, untreated brain metastases; patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed more than days prior to study entry and if clinical neurologic function is stable
Stable brain metastases either treated or being treated with a stable dose of steroids/ anticonvulsants, with no dose change within days prior to the first dose of study drug, will be allowed.
History of brain metastases unless irradiated ? weeks prior to first study treatment and stable without requirement of corticosteroids.
Active brain metastases (e.g. stable for < 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)
Patients with known active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients whose brain metastatic disease status has remained stable for >= weeks following treatment of brain metastases are eligible to participate at the discretion of the principal investigator
. Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases). Stable brain metastases either previously treated or being treated with a stable dose of steroids and/or anticonvulsants (no dose change within days prior to the first dose of study drug) will be allowed.
Participants with treated brain metastases are eligible for study participation; participants may not receive ongoing treatment with steroids at screening, anticonvulsants (at stable dose) are allowed
Patients with symptomatic brain metastases should be excluded from this clinical trial; however, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least - weeks without steroids may be enrolled at the discretion of the principal investigator
Patients with brain metastases are allowed only if they are off systemic corticosteroids and stable for a minimum of weeks
Patients with symptomatic brain metastases should be excluded from this clinical trial; however, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least week after the end of brain radiation may be enrolled to undergo molecular profiling at the discretion of the principal investigator; in addition, brain metastatic disease should be stable for at least weeks, before the patients can be enrolled in any of the experimental treatment arms
Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients with brain metastatic disease that has previously been treated and remained stable on MRI >= months after treatment, without steroids or anti-epileptic medications; these patients may be enrolled at the discretion of the principal investigator
Patients with brain metastases which are stable and have been treated with surgery or irradiation will be eligible for this trial
Patients with gliomas or brain metastases who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for month prior to enrollment; patients with known brain metastases should have had brain irradiation (whole brain or gamma knife) more than weeks before starting the protocol; note that patients should have had their steroids tapered to low dose (i.e., < . mg of dexamethasone/day)
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 >= weeks prior to study drug administration
Patients with untreated central nervous system metastases or local treatment of brain metastases within the last months; patients with stable brain metastasis for months post-intervention are eligible; subjects with chordoma will be eligible regardless of site of disease if other eligibility criteria are met
Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of weeks must have elapsed between the end of whole brain radiotherapy and study enrollment ( weeks for stereotactic radiotherapy).
Patients with treated, stable brain metastases eligible providing treatment was ? weeks prior to initiation of study drug, and baseline CT or MRI negative for new brain metastases. Must not require therapy with corticosteroids.
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.
Patients with known brain metastases may be excluded from this study. However, patients may be eligible if scans show limited disease or repeat scans show stable disease in the opinion of the investigator and patients have no ill effect from the metastases.
Uncontrolled or symptomatic brain metastases that are not stable, require steroids, are potentially life-threatening or that have required radiation within days prior to first dose of study treatment.
Any known symptomatic or untreated brain metastases requiring increase of steroid dose within weeks prior to starting on study. Patients with treated brain metastases must be stable for weeks after completion of that treatment. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
Patients with treated, stable brain metastases are allowed to enroll; patients must be at least weeks from radiation and off any medications used to treat brain metastases including steroids; patients are allowed to be on antiepileptic medications that are not metabolized by cytochrome P A or C; patients with brain metastases must have stable brain imaging within weeks prior to starting study
Presence of brain metastases, unless the patient has received adequate treatment at least weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least weeks prior to randomization;
Patients with primary central nervous system tumors or brain metastases. However, if radiation therapy and/or surgery has been completed and serial evaluation by CT (with contrast enhancement) or MRI over a minimum of months demonstrates the disease to be stable and if the patient remains asymptomatic, then the patient may be enrolled. Such patients must have no need for treatment with steroids or anti-epileptic medications.
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
Active brain metastases (e.g. stable for < 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)
Patients with asymptomatic brain metastases are allowed, as long as they are treated, stable, and do not require treatment with anticonvulsants or escalating doses of steroids; maximum daily dose of steroids should be prednisone mg or equivalent; radiation therapy for brain metastases must be completed at least days prior to treatment on protocol; patients with untreated brain metastases who are stable, asymptomatic and not requiring treatment with anticonvulsants or escalating doses of steroids are eligible
Patients with known symptomatic brain metastases requiring steroids and/or antiepileptic therapy; patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study treatment, and have discontinued corticosteroid treatment for these metastases for at least weeks and are neurologically stable; patients with leptomeningeal involvement are excluded
Stable, treated brain metastases are allowed; stable brain metastases are defined as stable on magnetic resonance imaging (MRI) weeks after the completion of radiation, and currently asymptomatic no longer requiring corticosteroids for weeks prior to the initiation of study drug
Untreated brain metastases. Subjects must have completed treatment for brain metastasis, and be neurologically stable off steroids, for at least days prior to first dose of study drug
Uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least weeks after definitive therapy and have not used steroids for at least weeks prior to first dose of ABBV-.
Patients with treated and stable brain lesions of a duration of >= months may be enrolled
Patients with brain metastases who require corticosteroids or non-enzyme inducing anticonvulsants must be on a stable dose of corticosteroids and seizure free for month prior to enrollment; patients with known brain metastases should have completed brain irradiation (whole brain or gamma knife) more than weeks before starting the protocol; patients on enzyme inducing anticonvulsants are not eligible; note that patients should have had their steroids tapered to low dose (i.e. < . mg of dexamethasone/day) due to the potential for higher dexamethasone doses to induce CYPA
Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases must be stable for weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of weeks must have elapsed between the end of whole brain radiotherapy and study enrollment ( week for stereotactic radiotherapy)
Histologically or cytologically documented extensive disease. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least month prior to study treatment.
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
All subjects with brain metastases, except those meeting the following criteria:\r\n* Brain metastases that have been treated locally and are clinically stable for at least weeks prior to enrollment \r\n* No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)\r\n* Subjects must be either off steroids or on a stable or decreasing dose of =< mg daily prednisone (or equivalent), excluding dexamethasone given as pre-treatment for trabectedin
Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of weeks must have elapsed between the end of whole brain radiotherapy and study enrollment ( weeks for stereotactic radiotherapy).
Presence of gliomas and brain metastases only if neurologically stable and treated without ongoing requirement for corticosteroids for at least weeks.
Have symptomatic CNS metastasis. Patients with a history of CNS metastases who have been treated with whole brain irradiation must be stable without symptoms for weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable does of steroids for ? weeks prior to enrollment.
Patients with known active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients whose brain metastatic disease status has remained stable for >= weeks following treatment of brain metastases are eligible to participate at the discretion of the principal investigator
Patient has a primary neoplasm of the brain or known uncontrolled metastases to the central nervous system (CNS). Patients with brain metastases are eligible, provided they have shown clinical and radiographically stable disease for at least weeks after definitive therapy and have not used steroids for at least weeks prior to first dose of PRN.