{
"info": {
"nct_id": "NCT00003462",
"official_title": "Phase I Study of Intrathecal Spartaject-Busulfan in Patients With Neoplastic Meningitis",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed neoplasm that is metastatic in the cerebrospinal fluid or leptomeningeal/subarachnoid space\n\n * Cytologic diagnosis of malignancy in the cerebrospinal fluid or neuroimaging evidence of leptomeningeal tumor by MRI\n* Must have a recurrent or refractory leptomeningeal tumor\n\n * Leptomeningeal tumors of leukemia, lymphoma, and all germ cell tumors must have also failed initial treatment or be recurrent\n* No evidence of obstructive hydrocephalus or complete block of the spinal cerebrospinal fluid pathways on prestudy technetium Tc 99m albumin or indium In 111 DTPA flow study\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* At least 8 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count greater than 1,500/mm^3\n* Platelet count greater than 100,000/mm^3\n\nHepatic:\n\n* Bilirubin less than 2.5 mg/dL\n* SGOT or SGPT less than 1.5 times normal\n\nRenal:\n\n* BUN less than 30 mg/dL\n* Creatinine less than 1.5 mg/dL\n* Calcium within normal limits\n\nNeurological:\n\n* Neurological examination stable\n* No rapidly progressing or deteriorating neurological deficits\n\nOther:\n\n* No active infectious process\n* Magnesium, phosphorus, potassium, chloride, and bicarbonate normal\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior immunotherapy\n\nChemotherapy:\n\n* At least 6 weeks since prior nitrosoureas or mitomycin\n* At least 4 weeks since any other prior chemotherapy\n* At least 3 weeks since prior intrathecal chemotherapy\n* No other concurrent intrathecal chemotherapy\n\nEndocrine therapy:\n\n* For patients on corticosteroids:\n\n * Must be on a stable dose of corticosteroids for at least 1 week\n\nRadiotherapy:\n\n* At least 3 weeks since prior radiotherapy to the CNS\n* At least 4 weeks since any other prior radiotherapy\n* No concurrent radiotherapy to the CNS\n\nSurgery:\n\n* At least 3 weeks since prior surgery\n\nOther:\n\n* No concurrent medication that may interfere with study results (e.g., immunosuppressive agents other than corticosteroids)"
},
"inclusion_lines": [
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"identified_line": {
"line": "Healthy volunteers allowed",
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"expected_value": "healthy"
}
}
]
},
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
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}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
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{
"exact_snippets": "DISEASE CHARACTERISTICS",
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"expected_value": "N/A"
}
}
]
},
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"exact_snippets": "DISEASE CHARACTERISTICS",
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}
]
}
},
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}
},
{
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}
},
{
"exact_snippets": "metastatic in the ... leptomeningeal/subarachnoid space",
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}
]
},
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"and_criteria": [
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},
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}
}
]
}
},
{
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{
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}
},
{
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"requirement_type": "evidence",
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}
},
{
"exact_snippets": "neuroimaging evidence of leptomeningeal tumor by MRI",
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}
}
]
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}
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"identified_line": {
"line": "* Leptomeningeal tumors of leukemia, lymphoma, and all germ cell tumors must have also failed initial treatment or be recurrent",
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{
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"germ cell tumors"
]
}
},
{
"exact_snippets": "must have also failed initial treatment",
"criterion": "treatment response",
"requirement": {
"requirement_type": "response",
"expected_value": "failed initial treatment"
}
},
{
"exact_snippets": "be recurrent",
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}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
"and_criteria": [
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}
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}
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}
]
}
},
{
"identified_line": {
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{
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"criterion": "obstructive hydrocephalus",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No evidence of ... complete block of the spinal cerebrospinal fluid pathways",
"criterion": "complete block of the spinal cerebrospinal fluid pathways",
"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "No evidence of obstructive hydrocephalus",
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}
},
{
"exact_snippets": "No evidence of ... complete block of the spinal cerebrospinal fluid pathways",
"criterion": "complete block of the spinal cerebrospinal fluid pathways",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "Age:",
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{
"exact_snippets": "Age:",
"criterion": "age",
"requirement": {
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Age:",
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]
}
},
{
"identified_line": {
"line": "* 18 and over",
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{
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"operator": ">=",
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"unit": "years"
}
]
}
}
}
]
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"exact_snippets": "Performance status:",
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"operator": ">=",
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"unit": "%"
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}
}
}
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{
"exact_snippets": "Karnofsky 60-100%",
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}
}
}
]
}
},
{
"identified_line": {
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}
]
},
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}
]
}
},
{
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}
}
]
}
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"identified_line": {
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]
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]
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count greater than 1,500/mm^3",
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{
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{
"identified_line": {
"line": "* Platelet count greater than 100,000/mm^3",
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}
]
}
},
{
"identified_line": {
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]
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},
{
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{
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}
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}
},
{
"identified_line": {
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"exact_snippets": "SGPT less than 1.5 times normal",
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]
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{
"identified_line": {
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]
},
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}
},
{
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"line": "* BUN less than 30 mg/dL",
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{
"exact_snippets": "BUN less than 30 mg/dL",
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]
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},
{
"identified_line": {
"line": "* Creatinine less than 1.5 mg/dL",
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{
"exact_snippets": "Creatinine less than 1.5 mg/dL",
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}
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]
}
},
{
"identified_line": {
"line": "* Calcium within normal limits",
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"exact_snippets": "Calcium within normal limits",
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}
]
},
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]
}
},
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}
]
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]
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},
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}
]
},
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}
}
]
}
},
{
"identified_line": {
"line": "* No rapidly progressing or deteriorating neurological deficits",
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{
"exact_snippets": "No rapidly progressing or deteriorating neurological deficits",
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}
},
{
"exact_snippets": "No rapidly progressing or deteriorating neurological deficits",
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}
}
]
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}
},
{
"exact_snippets": "No rapidly progressing or deteriorating neurological deficits",
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}
}
]
}
},
{
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"line": "* No active infectious process",
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{
"exact_snippets": "No active infectious process",
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}
}
]
},
"logical_structure": {
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"exact_snippets": "No active infectious process",
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"requirement_type": "presence",
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}
}
},
{
"identified_line": {
"line": "* Magnesium, phosphorus, potassium, chloride, and bicarbonate normal",
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{
"exact_snippets": "Magnesium ... normal",
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"requirement_type": "level",
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},
{
"exact_snippets": "phosphorus ... normal",
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"requirement_type": "level",
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},
{
"exact_snippets": "potassium ... normal",
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"requirement_type": "level",
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},
{
"exact_snippets": "chloride ... normal",
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"requirement_type": "level",
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},
{
"exact_snippets": "bicarbonate normal",
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"requirement_type": "level",
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}
]
},
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"and_criteria": [
{
"exact_snippets": "Magnesium ... normal",
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"requirement_type": "level",
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}
},
{
"exact_snippets": "phosphorus ... normal",
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"requirement_type": "level",
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},
{
"exact_snippets": "potassium ... normal",
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"requirement_type": "level",
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},
{
"exact_snippets": "chloride ... normal",
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"requirement_type": "level",
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},
{
"exact_snippets": "bicarbonate normal",
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"requirement_type": "level",
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}
},
{
"identified_line": {
"line": "* Fertile patients must use effective contraception",
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"exact_snippets": "Fertile patients",
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"requirement_type": "status",
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{
"exact_snippets": "must use effective contraception",
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"requirement_type": "necessity",
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"requirement_type": "status",
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},
"then_criteria": {
"exact_snippets": "must use effective contraception",
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"requirement_type": "necessity",
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},
"else_criteria": null
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},
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY:",
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"exact_snippets": "PRIOR CONCURRENT THERAPY",
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"requirement_type": "presence",
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]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
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"requirement_type": "presence",
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}
}
]
}
},
{
"identified_line": {
"line": "Biologic therapy:",
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"exact_snippets": "Biologic therapy",
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"requirement_type": "presence",
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"and_criteria": [
{
"exact_snippets": "Biologic therapy",
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"requirement_type": "presence",
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}
},
{
"identified_line": {
"line": "* At least 4 weeks since prior immunotherapy",
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{
"exact_snippets": "At least 4 weeks since prior immunotherapy",
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"requirement_type": "duration",
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"operator": ">=",
"value": 4,
"unit": "weeks"
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}
}
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},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least 4 weeks since prior immunotherapy",
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"requirement_type": "duration",
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"operator": ">=",
"value": 4,
"unit": "weeks"
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]
}
},
{
"identified_line": {
"line": "Chemotherapy:",
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{
"exact_snippets": "Chemotherapy",
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"requirement_type": "presence",
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}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Chemotherapy",
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"requirement_type": "presence",
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}
]
}
},
{
"identified_line": {
"line": "* At least 6 weeks since prior nitrosoureas or mitomycin",
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{
"exact_snippets": "At least 6 weeks since prior nitrosoureas",
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"requirement_type": "duration",
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"operator": ">=",
"value": 6,
"unit": "weeks"
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}
},
{
"exact_snippets": "At least 6 weeks since prior ... mitomycin",
"criterion": "time since prior mitomycin",
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"requirement_type": "duration",
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"operator": ">=",
"value": 6,
"unit": "weeks"
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}
}
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"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least 6 weeks since prior nitrosoureas",
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"requirement_type": "duration",
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"operator": ">=",
"value": 6,
"unit": "weeks"
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}
},
{
"exact_snippets": "At least 6 weeks since prior ... mitomycin",
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"requirement_type": "duration",
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"operator": ">=",
"value": 6,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* At least 4 weeks since any other prior chemotherapy",
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{
"exact_snippets": "At least 4 weeks since any other prior chemotherapy",
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"requirement_type": "duration",
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"operator": ">=",
"value": 4,
"unit": "weeks"
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"logical_structure": {
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{
"exact_snippets": "At least 4 weeks since any other prior chemotherapy",
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"requirement_type": "duration",
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"operator": ">=",
"value": 4,
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}
},
{
"identified_line": {
"line": "* At least 3 weeks since prior radiotherapy to the CNS",
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{
"exact_snippets": "At least 3 weeks since prior radiotherapy to the CNS",
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"requirement_type": "time since treatment",
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"operator": ">=",
"value": 3,
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}
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"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least 3 weeks since prior radiotherapy to the CNS",
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"requirement_type": "time since treatment",
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"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
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}
},
{
"identified_line": {
"line": "* At least 4 weeks since any other prior radiotherapy",
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"exact_snippets": "At least 4 weeks since any other prior radiotherapy",
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"requirement_type": "duration",
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"operator": ">=",
"value": 4,
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},
"logical_structure": {
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{
"exact_snippets": "At least 4 weeks since any other prior radiotherapy",
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"operator": ">=",
"value": 4,
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}
},
{
"identified_line": {
"line": "Surgery:",
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{
"exact_snippets": "Surgery:",
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"requirement_type": "presence",
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},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Surgery:",
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"requirement_type": "presence",
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},
{
"identified_line": {
"line": "* At least 3 weeks since prior surgery",
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{
"exact_snippets": "At least 3 weeks since prior surgery",
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"requirement_type": "time elapsed",
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"operator": ">=",
"value": 3,
"unit": "weeks"
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}
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{
"exact_snippets": "At least 3 weeks since prior surgery",
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"requirement_type": "time elapsed",
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"operator": ">=",
"value": 3,
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}
},
{
"identified_line": {
"line": "* No concurrent medication that may interfere with study results (e.g., immunosuppressive agents other than corticosteroids)",
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{
"exact_snippets": "No concurrent medication that may interfere with study results (e.g., immunosuppressive agents other than corticosteroids)",
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"requirement_type": "interference with study results",
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}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS:",
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},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Other:",
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{
"exact_snippets": "Tissue from tumor must be available",
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"requirement_type": "availability",
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}
},
{
"exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
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"requirement_type": "size",
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"operator": ">",
"value": 2,
"unit": "cm"
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Tissue from tumor must be available",
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"requirement_type": "availability",
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}
},
{
"exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
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"requirement_type": "size",
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"operator": ">",
"value": 2,
"unit": "cm"
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}
}
]
}
},
{
"identified_line": {
"line": "* Not pregnant or nursing",
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{
"exact_snippets": "Not pregnant",
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"requirement_type": "status",
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},
{
"exact_snippets": "not ... nursing",
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"requirement_type": "status",
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}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Not pregnant",
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"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "not ... nursing",
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"requirement_type": "status",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* At least 3 weeks since prior intrathecal chemotherapy",
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{
"exact_snippets": "at least 3 weeks since prior intrathecal chemotherapy",
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"requirement_type": "time since prior treatment",
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"operator": ">=",
"value": 3,
"unit": "weeks"
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "at least 3 weeks since prior intrathecal chemotherapy",
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"operator": ">=",
"value": 3,
"unit": "weeks"
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}
},
{
"identified_line": {
"line": "Other:",
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},
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],
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"failed_exclusion": [],
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{
"identified_line": {
"line": "* Must have a recurrent or refractory leptomeningeal tumor",
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{
"exact_snippets": "recurrent or refractory leptomeningeal tumor",
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"requirement_type": "status",
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"refractory"
]
}
}
]
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"logical_structure": {
"or_criteria": [
{
"exact_snippets": "recurrent or refractory leptomeningeal tumor",
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"requirement_type": "status",
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},
{
"exact_snippets": "recurrent or refractory leptomeningeal tumor",
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"requirement_type": "status",
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}
]
}
},
{
"identified_line": {
"line": "* No other concurrent intrathecal chemotherapy",
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{
"exact_snippets": "No other concurrent intrathecal chemotherapy",
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"requirement_type": "concurrency",
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}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
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"requirement_type": "failed",
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},
{
"identified_line": {
"line": "Endocrine therapy:",
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{
"exact_snippets": "Endocrine therapy",
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"requirement_type": "presence",
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"exact_snippets": "failed",
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},
{
"identified_line": {
"line": "* For patients on corticosteroids:",
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{
"exact_snippets": "patients on corticosteroids",
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"requirement_type": "presence",
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}
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"exact_snippets": "failed",
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"requirement_type": "failed",
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},
{
"identified_line": {
"line": "* Must be on a stable dose of corticosteroids for at least 1 week",
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{
"exact_snippets": "Must be on a stable dose of corticosteroids for at least 1 week",
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"requirement_type": "dose stability",
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}
},
{
"exact_snippets": "Must be on a stable dose of corticosteroids for at least 1 week",
"criterion": "corticosteroids",
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"requirement_type": "duration",
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"operator": ">=",
"value": 1,
"unit": "week"
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},
"logical_structure": {
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"identified_line": {
"line": "Radiotherapy:",
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{
"exact_snippets": "Radiotherapy",
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"requirement_type": "presence",
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},
"logical_structure": {
"exact_snippets": "failed",
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}
},
{
"identified_line": {
"line": "* No concurrent radiotherapy to the CNS",
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{
"exact_snippets": "No concurrent radiotherapy to the CNS",
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"requirement_type": "presence",
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]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No concurrent radiotherapy to the CNS",
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"requirement_type": "presence",
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}
}
}
}
]
}