[c09aa8]: / clusters / unpackedclusters / clust_191.txt

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Patients with suspected central nervous system (CNS) involvement should undergo lumbar puncture; those with documented CNS involvement will be excludedXx_NEWLINE_xXPatients with central nervous system (CNS) metastases must be stable after therapy for CNS metastases (such as surgery, radiotherapy or stereotactic radiosurgery) for at least 3 months and must be off steroid treatment prior to study enrollmentXx_NEWLINE_xXPatients with central nervous system 3 (CNS3) leukemia* CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapyXx_NEWLINE_xXPatients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma * Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registrationXx_NEWLINE_xXPatients with uncontrolled central nervous system (CNS) metastasis are not eligible; patients with CNS metastases are to be stable for > 3 months after treatment and off steroid treatment prior to study enrollmentXx_NEWLINE_xXParticipants with evidence for central nervous system (CNS) lymphoma on neurological exam and/or with radiographic evidence (if radiographic studies are done) of CNS lymphoma (inclusive of parenchymal, vitreal, or leptomeningeal involvement)Xx_NEWLINE_xXPatients must not have active involvement of the central nervous system (CNS) with MM (by clinical evaluation); patients with documentation of, or clinical signs or symptoms consistent with, CNS involvement of MM must have a lumbar puncture that is negative for CNS involvement of MM; the lumbar puncture must be completed within 14 days prior to registration; patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture prior to registration; note that monitoring of CNS involvement and treatment with intrathecal therapy is recommended during protocol treatmentXx_NEWLINE_xXPatients with a history of prior central nervous system (CNS) metastases or skull lesions with intracranial extension will be required to have a head computed tomography (CT) or magnetic resonance imaging (MRI) at study entry demonstrating no active CNS metastases; patients with skull metastases with associated intracranial soft tissue masses will remain eligibleXx_NEWLINE_xXAdequate central nervous system function defined as:* Patients with a history of central nervous system (CNS) disease must have no clinical or radiological evidence of CNS disease at the time of study enrollment* Patients with seizure disorders may be enrolled if seizures are well controlled on anticonvulsants* CNS toxicity =< grade 2Xx_NEWLINE_xXCentral nervous system diseaseXx_NEWLINE_xXKnown central nervous system metastasesXx_NEWLINE_xXPatient must have no current or prior history of central nervous system (CNS) involvementXx_NEWLINE_xXPatients must not have active central nervous system (CNS) involvement (by clinical evaluation); patients with previous documented history of CNS involvement of acute leukemia, or with clinical signs or symptoms consistent with CNS involvement of acute leukemia, must have a lumbar puncture which is negative for CNS involvement of acute leukemia; the lumbar puncture must be completed within 14 days prior to registration; patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture before registration; note that treatment with intrathecal therapy is recommended during protocol treatment but CNS analysis during treatment is not requiredXx_NEWLINE_xXActive CNS metastasesXx_NEWLINE_xXPatients with central nervous system (CNS) disease are not eligibleXx_NEWLINE_xXPatient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia; Parkinson�s disease, cerebellar disease, organic brain syndrome, psychosis, or other significant CNS abnormalitiesXx_NEWLINE_xXPatient must be CNS (cerebrospinal fluid [CSF]) negative for leukemiaXx_NEWLINE_xXFirst relapse of B-ALL, allowable sites of disease include isolated bone marrow, combined bone marrow and CNS and/or testicular, and isolated CNS and/or testicular; extramedullary sites are limited to the CNS and testiclesXx_NEWLINE_xXPatients with retinoblastoma protein (Rb1) positive recurrent, progressive or refractory central nervous system (CNS) tumorsXx_NEWLINE_xXPatients must not have known central nervous system metastasis or a history of central nervous system (CNS) metastases; patients with leptomeningeal disease are not eligibleXx_NEWLINE_xXPatient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson�s disease, cerebellar disease, organic brain syndrome, psychosis, active ALL in the CNS confirmed by cerebrospinal fluid (CSF) analysis, or other significant CNS abnormalitiesXx_NEWLINE_xXPatients must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration; patients with CNS3 are excluded from the trial; patients with CNS1 or CNS2 will be eligible, but will be monitored for CNS involvement; note that intrathecal methotrexate administered during the pre-study lumbar puncture may count as the first dose of intrathecal therapy required as part of the studyXx_NEWLINE_xXPatients with CNS tumors or known CNS metastases will be excluded from this trial; patients with a history of CNS metastases that have been previously treated may enroll if sequential imaging shows not evidence for active disease; patients with extra axial disease (e.g. skull [bone] metastasis that do not invade the dura) may enroll if there is no evidence for CNS edema associated with the lesionXx_NEWLINE_xXPatients with known central nervous system (CNS) metastases are not eligible; Note: brain imaging is not an eligibility requirementXx_NEWLINE_xXPatients with known central nervous system (CNS) involvement may be excluded; however, if CNS disease is cleared before the treatment with nivolumab, patients could be allowed if no permanent CNS damageXx_NEWLINE_xXNOTE: A lumbar puncture is not required in order to be enrolled on study nor are lumbar punctures recommended at the time of diagnosis; if the diagnosis of APL is known or suspected, diagnostic lumbar punctures in patients with neurologic symptoms should be deferred until any coagulopathy is corrected; if central nervous system (CNS) disease is suspected or proven, a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma; if CNS disease is documented, patients are still eligible and will receive protocol directed intrathecal treatmentsXx_NEWLINE_xXPatients with central nervous system (CNS) metastases must be stable after therapy for CNS metastases (such as surgery, radiotherapy or stereotactic radiosurgery) for at least 4 weeks and must be off steroid treatment for 2 weeks prior to study enrollmentXx_NEWLINE_xXPatients with known symptomatic, untreated central nervous system (including brain, spinal cord)* Patients who have a history of brain/central nervous system (CNS) metastasis are eligible for the study provided that all the following criteria are met:** Brain/CNS metastases which have been treated** No evidence of disease progression for >= 3 months before the first dose of study drug ** No hemorrhage after treatment** Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228** No ongoing requirement for dexamethasone or anti-epileptic drugsXx_NEWLINE_xXActive central nervous system (CNS) leukemiaXx_NEWLINE_xXPatients with untreated central nervous system (CNS) metastases; patients with treated CNS metastases who are off steroids are eligibleXx_NEWLINE_xXCentral nervous system (CNS) toxicity including peripheral neuropathy =< grade 2Xx_NEWLINE_xXRadiographic evidence of CNS metastasesXx_NEWLINE_xXPatients with known leptomeningeal or brain metastases should be excluded from this clinical trial; imaging or spinal fluid analysis to exclude central nervous system (CNS) involvement is not required, unless there is clinical suspicion by the treating investigatorXx_NEWLINE_xXPresence of any active central nervous system (CNS) disease at the time of evaluation (parenchymal or leptomeningeal)Xx_NEWLINE_xXPatients must have the status of CNS1 or CNS2 only, and no clinical signs or neurologic symptoms suggestive of CNS leukemia, such as cranial palsyXx_NEWLINE_xXCentral nervous system (CNS) toxicity =< grade 2Xx_NEWLINE_xXClinical evidence of (parenchymal or meningeal) central nervous system (CNS) involvement or metastasis; in subjects suspected of having CNS disease, a magnetic resonance imaging (MRI) scan of the brain and lumbar puncture should be done to confirmXx_NEWLINE_xXOptune device application start date must be at least 4 weeks (28 days) from central nervous system (CNS) surgical procedure; excluding ventriculoperitoneal (VP) shunts, endoscopic third ventriculostomy (ETV) for which treatment could start 10 days post procedure; non-CNS surgical procedures such as but not limited to central venous catheter insertion at the discretion of treating physician and study chairXx_NEWLINE_xXCentral nervous system (CNS) status must be determined based on a sample obtained prior to the administration of any systemic or intrathecal chemotherapy, with the exception of steroid pretreatmentXx_NEWLINE_xXPatients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:* Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:** Evaluable or measurable disease outside the CNS** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)** No history of intracranial hemorrhage or spinal cord hemorrhage** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted** No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1* Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:** Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and radiographic screening for the current study** No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1** Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroidsXx_NEWLINE_xXPatients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:* Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:** Evaluable or measurable disease outside the CNS** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)** No history of intracranial hemorrhage or spinal cord hemorrhage** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted** No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1* Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:** Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study** No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1** Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroidsXx_NEWLINE_xXCentral nervous system (CNS) involvement; CNS status must be confirmed by lumbar puncture* Note: lumbar puncture can be performed at the time of diagnosis and does not need to be repeated unless there is a change in neurological status or it was performed more than 14 days prior to study entryXx_NEWLINE_xXPatients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:* Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:** Evaluable or measurable disease outside the CNS** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)** No history of intracranial hemorrhage or spinal cord hemorrhage** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted** No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1* Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:** Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study** No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1** Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroidsXx_NEWLINE_xXPatients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:* Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:** There are no more than 3 lesions, =< 1 cm in size each** Evaluable or measurable disease outside the CNS** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)** No history of intracranial hemorrhage or spinal cord hemorrhage** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted** No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1* Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:** Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study** No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1** Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroidsXx_NEWLINE_xXCNS toxicity =< grade 2Xx_NEWLINE_xXPatients with active central nervous system leukemia are excluded from this clinical trial; patients with a history of central nervous system (CNS) leukemia but no active disease at the time of enrollment are eligible; the absence of CNS disease must be confirmed by flow cytometric and cytologic examination of the cerebrospinal fluid (CSF) within 7 days of study enrollmentXx_NEWLINE_xXPatients who have a history of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson�s disease, cerebellar disease, psychosis, or other significant CNS abnormalities; a history of treated CNS leukemia will be allowed if recent CNS studies confirm the absence of active CNS disease at the time of study entry (screening)Xx_NEWLINE_xXParticipants with known central nervous system (CNS) involvement with leukemia or who are receiving intrathecal chemotherapy that is either prophylactic or therapeutic; history of CNS involvement that has been completely treated (no longer receiving intrathecal chemotherapy) will be allowedXx_NEWLINE_xXPatients with symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; exceptions include patients with previously-treated CNS metastases or those with are asymptomatic, subcentimeter metastases, and have no requirement for steroids or anti-seizure medication for at least one week prior to study entry; screening with CNS imaging studies (CT scan or MRI) is requiredXx_NEWLINE_xXPatient does not have any documented history of central nervous system (CNS) involvement by mantle cell lymphoma; this includes no evidence of parenchymal brain, spinal cord, or cerebrospinal fluid involvement; radiculopathy symptoms from nerve root compression by lymphoma do not constitute CNS involvementXx_NEWLINE_xXPatients with isolated central nervous system (CNS), testicular, or other extramedullary site of relapseXx_NEWLINE_xXPatients must have no clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemiaXx_NEWLINE_xXUntreated central nervous system (CNS) involvementXx_NEWLINE_xXPatients must not have clinical evidence of central nervous system involvement by lymphoma; if performed, any laboratory or radiographic tests performed to assess central nervous system (CNS) involvement must be negativeXx_NEWLINE_xXPatients with central nervous system (CNS) metastases must have all lesions adequately treated with stereotactic radiation therapy, craniotomy, gamma knife therapy, or whole brain radiotherapy, with no subsequent evidence of CNS progression; patients must not have required steroids for at least 14 days prior to registrationXx_NEWLINE_xXPatients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excludedXx_NEWLINE_xX