Subjects with symptomatic brain metastases, carcinomatous meningitis, spinal cord compression, or intractable back pain due to compression of destructive mass
Evidence of untreated or progressive brain metastases, spinal cord compression, or carcinomatous meningitis
Active seizure disorder or evidence of untreated or progressive brain metastases, spinal cord compression, or carcinomatous meningitis\r\n* Subjects with brain metastases are eligible if they have been treated and there is no CT or magnetic resonance imaging (MRI) evidence for at least 4 weeks after central nervous system (CNS) metastasis treatment is complete
Spinal cord compression (unless treated with the patient attaining good pain control and stable or recovered neurologic function), carcinomatous meningitis, or leptomeningeal disease
Patients with uncontrolled seizure disorder, spinal cord compression or carcinomatous meningitis
Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
History of brain metastases, spinal cord compression, or carcinomatous meningitis
Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.
History of or known spinal cord compression or carcinomatous meningitis
CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis.
Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
History of leptomeningeal disease or spinal cord compression secondary to metastasis
Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible).
Known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression, patients with any of the above not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
No concurrent leptomeningeal disease or cord compression
Known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression, patients with any of the above not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
Symptomatic brain metastases, leptomeningeal carcinomatosis, or spinal cord compression (treated metastatic brain, leptomeningeal carcinomatosis, or spinal cord compression are allowed); Note: Patients must be off steroids used for brain metastases, leptomeningeal carcinomatosis, or spinal cord compression
Leptomeningeal carcinomatosis or cord compression
In the dose-finding portion of the study, participants with known or suspected parenchymal brain, spinal cord, leptomeningeal disease prior to study enrollment will be excluded; in the dose-expansion portion of the study, known or suspected parenchymal brain or spinal cord disease, and/or suspected or symptomatic leptomeningeal disease prior to study enrollment will be excluded; asymptomatic leptomeningeal disease only will be allowed in the dose-expansion cohort
Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment.
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients with evidence of CNS metastasis, spinal cord compression, or leptomeningeal disease within one year prior to enrollment will be excluded from this clinical trial; patients with a remote history of brain metastases may be considered if they received sterilizing therapy to the CNS (resection or radiation) and have been CNS progression free for the 1-year period; baseline imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with spinal cord compression may be considered if the condition is medically managed and currently asymptomatic
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients with evidence of CNS metastasis, spinal cord compression, or leptomeningeal disease within six months prior to enrollment will be excluded from this clinical trial; patients with a remote history of brain metastases may be considered if they received sterilizing therapy to the CNS (resection or radiation) and have been CNS progression free for the six months period; baseline imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with spinal cord compression may be considered if the condition is medically managed and currently asymptomatic
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients with evidence of CNS metastasis, spinal cord compression, or leptomeningeal disease within 1 year prior to enrollment will be excluded from this clinical trial; patients with a remote history of brain metastases may be considered if they received sterilizing therapy to the CNS (resection or radiation) and have been CNS progression-free for the 1-year period; baseline imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with spinal cord compression may be considered if the condition is medically managed and currently asymptomatic
Have symptomatic leptomeningeal carcinomatosis or spinal cord compression. Patients with asymptomatic leptomeningeal disease and no evidence of spinal cord compression are allowed.
Known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression, patients with any of the above not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
Known or suspected brain metastasis or active leptomeningeal disease or spinal cord compression
Known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required
Patient must not have known symptomatic leptomeningeal or brain metastases or spinal cord compression
History of central nervous system (CNS) lymphoma, leptomeningeal disease or spinal cord compression.
Presence of, or history of, central nervous system (CNS) lymphoma, leptomeningeal disease or spinal cord compression.
Patients with known leptomeningeal or brain metastases or spinal cord compression should be excluded from this clinical trial
Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.
have previously documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression
Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
The participant has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
Patients with history of brain metastases, spinal cord compression, or a history of leptomeningeal carcinomatosis;
Patients with history of brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
Current leptomeningeal metastases or spinal cord compression due to disease.
Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis
Leptomeningeal metastases or spinal cord compression due to disease.
Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
Brain metastases, or spinal cord compression. Individuals with brain metastases are allowed if they have been treated with irradiation or surgery, are clinically stable without steroid treatment. Individuals with documented leptomeningeal disease are not eligible.
Symptomatic leptomeningeal, brain metastases, or spinal cord compression.
Known leptomeningeal involvement, brain metastases or spinal cord compression.
History of leptomeningeal disease or spinal cord compression secondary to metastasis.
Subjects with leptomeningeal or brain metastases or spinal cord compression.
Has brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease
Previous brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
Subjects must not have a history of clinically manifested central nervous system (CNS) metastases. a. Subjects with known or suspected leptomeningeal disease or cord compression are not eligible.
History of leptomeningeal disease or spinal cord compression
Known or suspected brain metastasis or active leptomeningeal disease or spinal cord compression
Concurrent neuromuscular disorder that is associated with the potential of elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Concurrent neuromuscular disorder that is associated with the potential of elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: History of neuromuscular disorders that are associated with elevated CK (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
EXPANDED ACCESS COHORT: History of neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have a neuromuscular disorder that is associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular disorders that are associated with elevated creatinine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as 3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA) inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting sonidegib study treatment; if it is essential that the patient stays on a statin to control hyperlipidemia, only pravastatin may be used with extra caution
Patients who have neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as 5-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment; NOTE: if it is essential that the patient stays on a statin to control hyperlipidemia, only pravastatin may be used with extra caution
Patients who have neuromuscular disorders that are associated with elevated creatinine phosphokinase (i.e. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular disorders that are associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy)
Neuromuscular disorders associated with elevated creatine kinase (CK, e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, or spinal muscular atrophy)
History of neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular disorders that are associated with elevated creatinine phosphokinase (i.e. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as 3-hydroxy-3-methylglutaryl (HMG) coenzyme A (CoA) inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment; patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment, should also be excluded; muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment
Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as 3-hydroxy-3-methylglutaryl-CoA (HMG CoA) inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 5 half lives prior to starting LDE225 treatment; NOTE: if it is essential that the patient stays on a statin to control hyperlipidemia, only pravastatin may be used with extra caution
Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as hydroxymethyl glutaryl coenzyme A (HMG CoA) inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment
Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment; if it is essential that the patient stays on a statin to control hyperlipidemia, only pravastatin may be used with extra caution
Patients who have neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular or muscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are known to cause rhabdomyolysis (such as statins and fibrates), and that cannot be discontinued at least 2 weeks prior to starting LDE225; if it is essential that the patient stays on a statin for hyperlipidemia, only pravastatin may be used with extra caution; patients should not plan to embark on a new strenuous exercise regimen after initiation of study treatment; (nota bene [NB]: muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment)
Patients who have neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular disorders that are associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) or elevated baseline CK levels (? Grade 2)
Patients who have neuromuscular disorders that are associated with elevated CK (Creatine phosphokinase) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
Patients who have neuromuscular disorders that are associated with elevated CK (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy)
Patients who have neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment; if it is essential that the patient stays on a statin to control hyperlipidemia, only pravastatin may be used with extra caution\r\n* Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment; NB: muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
Symptomatic or untreated leptomeningeal disease or spinal cord compression
Patients with untreated spinal cord metastases are eligible if lesions are asymptomatic
Patient has spinal cord compression or symptomatic brain metastases.
Has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression; treated brain metastases must have been stable for at least 1 month and require treatment with less than 10 mg/day prednisone equivalent for at least two weeks prior to study drug administration
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression; treated brain metastases are allowed as long as they are stable for at least 28 days post-treatment
Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression; if these were treated and clinically stable for 4 weeks, patient can be considered for the trial
Known brain metastases or spinal cord compression
Has symptomatic or untreated leptomeningeal, brain metastases, or spinal cord compression.
Untreated symptomatic spinal cord compressions
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression (patients with controlled central nervous system [CNS] disease, i.e. asymptomatic and currently receiving concurrent intrathecal chemotherapy, are eligible upon discussion with the principal investigator)
Symptomatic or untreated CNS metastases or spinal cord compression. Brain metastasis must be stable with verification by imaging .
Are symptomatic or have uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation (brain metastases that are stable and asymptomatic, either treated or untreated, will be allowed)
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
Symptomatic or untreated leptomeningeal disease, brain metastasis, or spinal cord compression
Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression
Spinal cord compression or brain metastases
Patients with untreated brain metastases, spinal cord compression, or leptomeningeal carcinomatosis are excluded from this clinical trial; patients with brain metastases or spinal cord compression previously treated with radiation and/or surgery are allowed if local treatment was > 30 days ago, most recent MRI demonstrates stability or decrease in size of all lesions, and the patient has no current neurologic symptoms related to the metastases and treatment and no requirement for corticosteroids related to the prior treatment
Active or untreated brain metastases or spinal cord compression
Symptomatic or untreated spinal cord compression
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery).
Symptomatic or untreated spinal cord compression
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
Patients with symptomatic or untreated leptomeningeal or brain metastasis or spinal cord compression
Have known untreated brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease.
Subject has symptomatic brain metastases, spinal cord compression, or intractable back pain due to compression of destructive mass.
Untreated symptomatic spinal cord compressions
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression.
Untreated spinal cord compression
Brain metastases or spinal cord compression.
Known spinal cord compression or brain or liver metastasis
Unstable brain metastases or spinal cord compression
Patients with known brain metastases or spinal cord compression should be excluded from this clinical trial
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression; treated brain metastases must have been stable for at least 1 month
Untreated brain metastasis or history of leptomeningeal disease or spinal cord compression.
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
Untreated symptomatic spinal cord compressions
History of, or current metastases in the brain, meninges, or untreated spinal cord compression
History of, or current known metastases in the brain or untreated spinal cord compression
Uncontrolled brain or spinal cord metastases
Symptomatic or untreated leptomeningeal, CNS or brain metastases or spinal cord compression at the time of transition to this study.
Subjects with symptomatic brain metastases, spinal cord compression, or intractable back pain due to a compressive or destructive mass
Patients with untreated spinal cord metastases or metastases close to vital organs (as determined by the principal investigator) are excluded
Untreated spinal cord compression.
Symptomatic or untreated leptomeningeal disease or brain metastases or spinal cord compression
Untreated or inadequately treated spinal cord compression
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression.
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression; treated brain metastases must have been stable for at least 1 month
Symptomatic or untreated brain metastases or spinal cord compression or any of these conditions requiring chronic steroids to control symptoms.
Subjects with CNS symptoms should undergo a CT scan or MRI of the brain to exclude new or progressive brain metastases. Spinal cord metastasis is acceptable. However, subjects with spinal cord compression should be excluded.
History of or known presence of brain or spinal cord metastases
Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for >/= 14 days
Diagnosis of primary brain tumor; untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
Untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
Untreated or symptomatic brain metastasis, leptomeningeal disease or spinal cord compression. Subjects who are on a stable dose of corticosteroids for more than 1 month or off corticosteroids for 2 weeks can be enrolled with approval of medical monitor. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs.
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression; patients with treated central nervous system (CNS) metastasis, no longer requiring steroid therapy are potentially eligible; patients with primary glioblastoma multiforme not requiring steroid therapy will be eligible
Patients with a current, untreated spinal cord compression
History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for at least 28 days prior to randomization
History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
Symptomatic or uncontrolled brain metastases requiring concurrent treatments, uncontrolled spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease; uncontrolled seizures.
Known central nervous system metastasis; patients with known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease may be enrolled if they have been treated, are no longer taking corticosteroids, and have been stable on imaging for at least 3 weeks
History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease (Note: Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered over the 14 days prior to study treatment)
History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease; patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for at least 28 days
History of brain metastases, uncontrolled spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for at least 28 days.
History of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for at least 28 days.
Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
Participant has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
E 07. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening computed tomography (CT) scan or MRI
History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease
Brain metastases (even if treated and/or stable), spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for brain edema for at least 28 days
Uncontrolled tumor-related pain or impending spinal cord compression.
Patients whose primary tumors arise in the intra-dural soft tissue (eg. brain and spinal cord) are not eligible
Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible
Based on prior radiation records, have had most of the tumor volume (> 50%) previously radiated at doses >= 45 gray (Gy) without exceeding spinal cord tolerance (combining previous and future radiation dose to 1 cc of the spinal cord of =< 60 Gy)
Tumors involving spinal cord or heart
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 2 weeks prior to randomization
Epidural tumor < 2 mm from spinal cord
Tumors that are primarily localized within the brainstem or spinal cord
Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome
Spinal surgery carried out with the goal of spinal cord decompression and spinal stabilization within 8 weeks
Lack of adequate (>= 2 mm) separation between the spinal cord and the tumor on post-operative CT myelogram or MRI perfusion
Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon spinal cord
Evidence of spinal cord compression
Patients with tumors lying close to an airway, major blood vessel or spinal cord that, in the opinion of the investigator, could cause occlusion or compression in the case of swelling, or erosion into a major vessel in the case of necrosis.
Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
Metastatic disease impinging on the spinal cord or threatening spinal cord compression; patients that have had previous treatment of disease with impinging on the cord with either surgery or radiotherapy with clinical or radiographic evidence of response or stability are eligible
Metastatic disease impinging on the spinal cord or threatening spinal cord compression
Subjects with known symptomatic or impending spinal cord compression, except if subject has received definitive treatment for this and demonstrates evidence of clinically stable disease
Osseous metastases felt in the opinion of the clinician to be high-risk for impending pathologic fracture or spinal cord compression
Spinal cord compression unless good pain control attained
Radiologic or clinical evidence of spinal cord compression
Patients with primary spinal cord tumors
Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, severe and extensive spinal metastases with concern over spinal cord compression, extensive liver metastases)
Spinal cord compression not definitively treated with surgery and/or radiation
Patients with spinal disease
Patients with radiographic or clinical findings of spinal cord compression or cauda equina syndrome with neurologic deficit thought to be due to malignancy
Spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to randomization
Has imminent or established cord compression based on clinical findings and/or MRI
Known spinal cord compression
Presence of extracranial metastatic, significant leptomeningeal disease or tumors primarily localized to the brainstem or spinal cord.
Spinal cord compression that has not definitively treated with surgery and/or radiation
Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
Known symptomatic or impending cord compression
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation
Highly symptomatic patients (e.g., declining ECOG performance status; rapidly worsening symptoms; rapid progression of disease; progression of tumor at critical anatomical sites [e.g., spinal cord compression] requiring urgent alternative medical intervention) are not eligible
Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); spinal cord compression will be defined as 360 degree circumferential obliteration of T2 cerebrospinal fluid signal around the spinal cord; treatment should be completed for spinal cord compression
Patients with evidence of tumor in the brainstem, cerebellum, optic apparatus, or spinal cord, radiological evidence of actively growing multifocal disease, or leptomeningeal disease
Patients with untreated spinal cord compression; patients with spinal cord compression may be enrolled if stable after completing surgery (may enroll 14 days after surgery) or radiation (may enroll 14 days after treatment) and must be off corticosteroids for at least 14 days prior to the start of study treatment
Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression
Symptomatic or impending spinal cord compression or cauda equina syndrome.
Patients that require urgent therapy due to tumor mass effects or spinal cord compression
Prognostic Index for Spinal Metastases (PRISM) group 1-3
Has tumor primarily localized to the brainstem or spinal cord
Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord, radiological evidence of active (growing) multifocal disease, subependymal or leptomeningeal disease
Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function, or spinal cord compression will be excluded from this study unless these issues have been taken care of
No history of tumors involving spinal cord or heart
Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function or spinal cord compression will be excluded from this study unless these issues have been taken care of
Motor strength >= 4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength < 4/5 in extremity or extremities affected by the level of the spinal cord compression)
Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, or with evidence of leptomeningeal disease
PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: Has tumor localized primarily to the posterior fossa, spinal cord, or an unresectable location
PHASE I: Tumor localized primarily to the posterior fossa or spinal cord
Patients that require urgent therapy due to tumor mass effects or spinal cord compression
Has imminent or established spinal cord compression based on clinical findings and/or MRI
Tumors lying in mucosal regions or close to an airway, major blood vessel or spinal cord.
Imminent or established spinal cord compression based on clinical and/or imaging; in subjects with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 4 weeks before enrollment
Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, both kidneys) within 1 year of the treatment date
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression
Patients must have demonstrated progression of disease on MRI or computed tomography (CT) assessment of the spinal cord/cauda within the previous radiation field\r\n* Progression may consist of an increase in maximal dimension of the tumor by >= 20%, compromise of the spinal cord/cauda equina and/or exiting spinal nerves (assessed clinically or radiographically), or both
Unable to undergo either a myelogram or MRI of spinal cord/cauda equina and/or exiting spinal nerves
Patients who may not receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by the Dose Limit Guidelines \r\n* Evaluation of doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, kidneys, rectum) will be taken into consideration\r\n* If repeat irradiation would exceed any normal tissue constraint the patient will be ineligible \r\n* If the total prior radiation dose to the spinal cord/cauda equina and/or sacrum over all prior treatments exceeds 100 Gy BED (biologically effective dose), the patient will be ineligible
Tumor within 1 cm of the spinal cord
Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)
Metastatic deposits near a great vessel or spinal cord
Subjects with spinal cord compression
Exposure to any prior chemotherapy or steroid use within 14 days of study-related drug therapy; (steroid use is allowed if necessary to treat spinal cord compression)
Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus)
T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart
Patients with primarily infra-tentorial or spinal cord tumor are not eligible
Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
Subjects with radiographic signs of excessive intracranial mass effect with associated rapid neurologic deterioration, and/or spinal cord block
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >/=2 weeks prior to Day 1 of Cycle 1
Evidence of spinal cord compression or CNS complication unless controlled by appropriate therapy.
Clinical spinal cord compression syndromes (unless patient has undergone treatment, for example, surgery or radiation therapy, and neurological findings are ? Grade 1 and patient is off corticosteroids for spinal cord edema or on a stable regimen of < 10 mg/day prednisone equivalent
Patients with primary tumor location of brainstem or spinal cord
Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)
Spinal cord compression or impending spinal cord compression
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression
Patients with symptomatic metastatic prostate cancer experiencing moderate to severe pain, impaired organ function or spinal cord compression will be excluded from this study unless these issues have been addressed
Subjects with radiographic signs of excessive intracranial mass effect with associated rapid neurologic deterioration and/or spinal cord block
Tumors primarily localized in the infratentorial compartment or spinal cord – tumors with limited infratentorial compartment or spinal cord involvement are eligible
Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
Patients that require urgent therapy due to tumor mass effects or spinal cord compression
Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 54 Gy (prior plus planned dose)
Current symptomatic cord compression requiring surgery or radiation therapy
Patients must have symptomatic multiple myeloma without advanced organ damage (such as multiple fractures or advanced bone disease causing immobilization, renal failure, spinal cord compression, or organ compromise due to soft tissue plasmacytoma); if immediate therapy with radiation and high-dose steroids (e.g., for spinal cord compression) or if triple therapy is clearly advisable from the start, the patient is not eligible for this trial
Complicated bone metastases including clinical or radiological evidence of spinal cord compression or impending pathological fracture
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than (>) 2 weeks prior to randomization
First day of dosing with tesevatinib is less than 4 weeks from the last radiotherapy of the brain or spinal cord/cauda equina
No history of tumors involving spinal cord or heart
No tumors involving spinal cord or heart
Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted.
Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
Anticipated treatment of the index tumor that would require iceball formation within 0.5 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel (possibly achieved with additional maneuvers such as hydrodissection)
Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only; radiotherapy must be completed at least 14 days prior to registration and all toxicities must have resolved to =< grade 1
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to screening
Spinal cord compression not definitively treated or not clinically stable
Subject has experienced acute pathologic fracture or spinal cord compression within 28 days prior to first dose of study therapy
Presence of tumor cells in the brain or spinal cord that have not been treated
Evidence of diffuse subependymal disease or tumor in the brainstem, cerebellum, spinal cord, or CSF.
Spinal cord compression or impending spinal cord compression
Imminent or established spinal cord compression based on clinical and/or imaging; in patients with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 4 weeks before enrollment
Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of multifocal disease, or leptomeningeal disease
Following breast cancer disease conditions are not eligible:\r\n* Single bone lesion\r\n* Two or more visceral metastasis\r\n* Single visceral lesion < 2 cm without any laboratory changes or clinical symptoms due to the metastatic lesion is permitted\r\n* Presence of brain metastases\r\n* Imminent spinal cord compression based on clinical findings and/or MRI\r\n* Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression\r\n* Life expectancy severely limited by concomitant illness (less than 12 months)\r\n* Concurrent external beam radiation therapy to non-target lesion is permitted
Has tumor localized primarily to the brainstem or spinal cord
Has tumor primarily localized to the brainstem or spinal cord
Current or imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression
The generated planning target volume 1 (PTV1) must be > 5 mm from the spinal cord or brain
The generated PTV1 is located within 5 mm of spinal cord or brain
Have current spinal cord compression.
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered
Have active cancer in the brain or spinal cord
Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome.
Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
Histologically confirmed, previously untreated CD30+ classical HL; (participants receiving limited emergent radiation therapy [RT] or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment)
Tumor to be treated should not directly about the spinal cord, and should have at least 5mm separation from the spinal cord; for patients with tumors closer than 5mm, inclusion is permissible at the discretion of the treating radiation oncologist such that dosimetric review demonstrates that the total dose to spinal cord is within tolerable range of < 10 Gy to 10% partial volume or max point dose 18 Gy
Patients with evidence of spinal instability OR neurologic deficit resulting from bony compression of neurologic structures
Any patient with symptoms of pain, compression fracture, neurologic deficit attributable to spinal metastases will not be included
Patients with neoplastic lesions in the brainstem, cerebellum or spinal cord, radiological evidence of active (growing) multifocal disease, or leptomeningeal disease will be excluded; patients with evidence of diffuse subependymal disease or tumor in the brainstem, cerebellum, spinal cord, or cerebrospinal fluid (CSF) will also be excluded\r\n* Patients with radiological evidence of active (growing) multifocal disease, tumors extending into or crossing the corpus callosum or leptomeningeal disease, will be excluded
Must be no clinical or radiographic evidence of spinal cord compression
Prior spinal cord maximum dose at level of vertebral disease must be =< 50 Gy
Patients must have symptomatic multiple myeloma without advanced organ damage (such as multiple fractures or advanced bone disease causing immobilization, renal failure, spinal cord compression, or organ compromise due to soft tissue plasmacytoma); if immediate therapy with radiation and high-dose steroids (e.g., for cord compression) or with bortezomib-based therapy (e.g., for renal failure) is required, the patient is not eligible for this trial
Spinal cord compression within 6 months
Spinal cord compression or canal compromise requiring decompression,
Index tumor(s) causing clinical or radiographic evidence of spinal cord or cauda equine compression/effacement
Patients with evidence of other tumor masses in the spinal cord will be eligible unless there is evidence of spinal cord block radiographically or clinically
Anatomical considerations:\r\n* If the patient has >= 4 sites; only the 3 most painful sites of disease will be treated; or, in the absence of pain, the 3 levels at greatest risk of impending collapse, based on extent of involvement, presence of posterior element involvement, or biomechanical risk based on location (mid-thoracic area, thoraco-lumbar junction, lumbosacral junction)\r\n* Spinal cord compression with or without peridural spread\r\n* Neurologic compromise due to spinal cord compression
PART II: Participants must be without evidence of active spinal cord compression
Prior treatment for MM (prior radiation therapy or dexamethasone up to 160 mg for spinal cord compression is allowed. Other limited field radiation involving ? 1/3 of the pelvic area is also allowed)
Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
Participant has spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to screening Treatment-Specific Exclusion Criteria:
Conditions related to tumor, which require emergency treatment (airway compression, spinal cord compression) since enrollment would delay initiation of such therapy
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression
Symptomatic or impending spinal cord compression or cauda equine syndrome
Symptomatic or impending spinal cord compression or cauda equina syndrome.
Spinal cord or cauda equine compression/effacement in vertebral metastases with neurological symptoms other than just pain for the lesion that is planned for treatment
Patents with cord compression
Patients with epidural compression are eligible provided that there is a >= 3 mm gap between the spinal cord and the edge of the epidural lesion
Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord
Presence of spinal cord injury including any form of paraplegia or quadriplegia
History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity
Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma
History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity
Congenital spinal defect/paraplegia
Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: need for external beam radiotherapy (EBRT) to bone pain, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted.
Any spinal pathology which can prevent safe administration of epidural/ spinal anesthesia
Eminent or established cord compression as assessed by medical record review
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomization
Spinal cord compression.
Primary brainstem or spinal cord tumor
Spinal cord compression is excluded unless the patient demonstrates good pain control attained through therapy and there is stabilization or recovery of neurological function for two weeks prior to study entry
History of spinal cord compression
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to enrollment
Spinal cord compression.
Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; the patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to enrollment; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
Spinal cord compression or brain metastases unless asymptomatic, treated, stable, and not requiring steroids for at least 4 weeks before first dose of study drug
Spinal cord compression or brain metastases unless asymptomatic treated and stable and not requiring steroids
Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
Subject with known active CNS metastasis, except primary brain tumors. Subjects with asymptomatic brain metastases or spinal cord compression who have been treated, are considered stable, and have not received steroid doses > 10 mg/day of prednisolone equivalent to treat these conditions prior to consent may be included;
Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable for at least 4 weeks prior to the first dose of study medication
Active or untreated brain metastases or spinal cord compression\r\n* A scan to confirm the absence of brain metastases is not required\r\n* Patients with treated brain metastases or spinal cord compression are eligible if they have minimal neurologic symptoms and evidence of stable disease (for at least 1 month) or response on follow-up scan; the patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 28 days prior to treatment
Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study treatment.
Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
Has known brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases; and stable and off steroids for at least 14 days prior to start of study treatment); following radiotherapy and/or surgery of the brain metastases patients must wait 4 weeks following the intervention and before initiating study treatment with imaging to confirm stability
Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have a magnetic resonance imaging (MRI) (preferred) or CT each preferably with IV contrast of the brain prior to study entry or brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases; and stable and off steroids and anti-convulsants for at least 14-28 days prior to start of study treatment). Following radiotherapy and/or surgery of the brain metastases patients must wait 4 weeks following the intervention to confirm stability.
Brain metastases or spinal cord compression unless asymptomatic and not requiring steroids for at least 14 days prior to start of study treatment
Patients with symptomatic uncontrolled brain metastases or spinal cord compressions. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 28 days prior to treatment.
Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 28 days prior to study treatment start. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.
Known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and/or radiation, and has been stable without requiring corticosteroids nor anticonvulsant medications for at least 4 weeks prior to the first dose of study medication. Patients with history of brain metastases should undergo brain imaging within 4 weeks of therapy initiation and at each restaging
Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and/or radiation, and has been stable without requiring escalating corticosteroids nor anti-convulsant medications for at least 4 weeks prior to the first dose of study medication
Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before study entry, and stable without steroid treatment for at least 4 weeks
Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment
Has a spinal cord compression unless asymptomatic, radiographically stable over the last 4 weeks, and not requiring steroids for at least 4 weeks before the start of study treatment
Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 3 months
Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; Subjects requiring steroids within 4 weeks prior to start of study treatment will be excluded;
Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids for at least 14 days prior to the start of study treatment. Patients with suspected or known brain metastases at screening should have an MRI (preferred)/CT, preferably with IV contrast to access baseline disease status.
Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 30 days
Brain metastases or spinal cord compression that requires treatment, unless the treatment ended at least 4 weeks before starting protocol therapy and the condition has been stable without steroid treatment for at least 10 days
Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment. - Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other than SCCHN in the past 3 years. Exceptions are
Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; the patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
Subjects with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable and asymptomatic.
Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; the patient can receive a stable dose of corticosteroids before and during the study if these were started at least 4 weeks prior to treatment; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days; patients with known uncontrolled brain metastases should be excluded from this clinical trial
Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 6 weeks prior to start of study treatment
Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ?470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient
Has history of brain metastasis, spinal cord compression (unless treated, asymptomatic, and stable on most recent imaging and enrolling in expansion cohort), or lymphoma involving the central nervous system (CNS)
Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids.
Patients who have symptomatic, uncontrolled spinal cord compression and/or brain metastases; a scan to confirm absence of brain metastasis is not required; patients can receive a stable dose of corticosteroids (except those prohibited per protocol) before/during study if these were started at least 28 days prior to entry
Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
Unstable brain metastases or spinal cord compression that requires treatment, unless the treatment ended at least 4 weeks before starting treatment and the condition has been stable without steroid treatment for at least 10 days
Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment.
Patients with stable CNS primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms and steroid use (if applicable) have been stable for 7 days prior to the first dose of LOXO-195
Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
Patients with brain metastases or spinal cord compression unless they completed radiation therapy >= 4 weeks prior to the first dose of ponatinib and are stable without steroids or anti-convulsant therapy for >= 10 days
Patients may not have symptomatic, uncontrolled spinal cord compression and/or brain metastases; a scan to confirm absence of brain metastasis is not required; patients can receive a stable dose of corticosteroids before/ during study if these were started at least 28 days prior to entry
History of spinal cord compression or brain metastases, unless asymptomatic, treated, stable, and not requiring treatment with steroids for at least 4 weeks before the planned administration of the first dose of study drug. Any history of leptomeningeal metastases.
Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before study entry, and stable without steroid treatment for at least 4 weeks
Spinal cord compression or brain metastases unless asymptomatic and not requiring steroids for at least 4 weeks
Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for >/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.
Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; patients with suspected brain metastases at screening should have a CT/magnetic resonance imaging (MRI) of the brain prior to study entry