{
"info": {
"nct_id": "NCT00007982",
"official_title": "CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant tumors\n\n * Anaplastic astrocytoma\n * Oligodendroglioma\n * Germ cell tumor\n * Medulloblastoma\n * Primary neuroectodermal tumor\n * Esthesioneuroblastoma\n * CNS lymphoma (primary or systemic disease)\n* Multifocal intracranial disease allowed\n* No extraneural metastases (except controlled systemic lymphoma)\n* Pretreatment considerations based on tumor type\n\n * Anaplastic astrocytoma:\n\n * Recurrent disease\n * Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2)\n * Chemotherapy not required at recurrence\n * Oligodendroglioma:\n\n * Disease response (at least minor) to conventional chemotherapy OR\n * Recurrent disease\n * Esthesioneuroblastoma:\n\n * Attempted complete surgical resection\n * Disease progression after radiotherapy\n * Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin\n * CNS lymphoma:\n\n * Disease refractory to methotrexate OR\n * Failure after initial treatment with methotrexate OR\n * Considered at high risk for disease relapse despite initial response\n* Radiographic or pathological confirmation of recurrent disease required\n* Not eligible for other high priority national or institutional clinical studies\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG or Zubrod 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Creatinine less than 1.5 times normal\n\nCardiovascular:\n\n* LVEF at least 45%\n\nPulmonary:\n\n* DLCO at least 60% predicted OR\n* Approval of pulmonologist\n\nOther:\n\n* Not pregnant or nursing\n* HIV negative\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* No concurrent anticancer hormonal therapy\n* No concurrent steroids as antiemetics\n\nRadiotherapy:\n\n* See Disease Characteristics\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* No concurrent barbiturates or acetaminophen\n* Participation in other concurrent supportive care or gene therapy trials allowed"
},
"inclusion_lines": [
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* Histologically confirmed malignant tumors",
"criterions": [
{
"exact_snippets": "Histologically confirmed malignant tumors",
"criterion": "malignant tumors",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
]
}
]
},
{
"line": "* Anaplastic astrocytoma",
"criterions": [
{
"exact_snippets": "Anaplastic astrocytoma",
"criterion": "anaplastic astrocytoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Oligodendroglioma",
"criterions": [
{
"exact_snippets": "Oligodendroglioma",
"criterion": "oligodendroglioma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Germ cell tumor",
"criterions": [
{
"exact_snippets": "Germ cell tumor",
"criterion": "germ cell tumor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Medulloblastoma",
"criterions": [
{
"exact_snippets": "Medulloblastoma",
"criterion": "medulloblastoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Primary neuroectodermal tumor",
"criterions": [
{
"exact_snippets": "Primary neuroectodermal tumor",
"criterion": "neuroectodermal tumor",
"requirements": [
{
"requirement_type": "type",
"expected_value": "primary"
}
]
}
]
},
{
"line": "* Esthesioneuroblastoma",
"criterions": [
{
"exact_snippets": "Esthesioneuroblastoma",
"criterion": "esthesioneuroblastoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* CNS lymphoma (primary or systemic disease)",
"criterions": [
{
"exact_snippets": "CNS lymphoma (primary or systemic disease)",
"criterion": "CNS lymphoma",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"primary",
"systemic"
]
}
]
}
]
},
{
"line": "* Multifocal intracranial disease allowed",
"criterions": [
{
"exact_snippets": "Multifocal intracranial disease allowed",
"criterion": "multifocal intracranial disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No extraneural metastases (except controlled systemic lymphoma)",
"criterions": [
{
"exact_snippets": "No extraneural metastases",
"criterion": "extraneural metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "controlled systemic lymphoma",
"criterion": "systemic lymphoma",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "controlled"
}
]
}
]
},
{
"line": "* Pretreatment considerations based on tumor type",
"criterions": [
{
"exact_snippets": "Pretreatment considerations based on tumor type",
"criterion": "tumor type",
"requirements": [
{
"requirement_type": "considerations",
"expected_value": "pretreatment"
}
]
}
]
},
{
"line": "* Anaplastic astrocytoma:",
"criterions": [
{
"exact_snippets": "Anaplastic astrocytoma",
"criterion": "anaplastic astrocytoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Recurrent disease",
"criterions": [
{
"exact_snippets": "Recurrent disease",
"criterion": "disease recurrence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2)",
"criterions": [
{
"exact_snippets": "Any treatment at diagnosis allowed",
"criterion": "treatment at diagnosis",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
}
]
},
{
"exact_snippets": "carmustine dose limited to 480 mg/m2",
"criterion": "carmustine dose",
"requirements": [
{
"requirement_type": "limit",
"expected_value": {
"operator": "<=",
"value": 480,
"unit": "mg/m2"
}
}
]
}
]
},
{
"line": "* Chemotherapy not required at recurrence",
"criterions": [
{
"exact_snippets": "Chemotherapy not required at recurrence",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "necessity at recurrence",
"expected_value": false
}
]
}
]
},
{
"line": "* Oligodendroglioma:",
"criterions": [
{
"exact_snippets": "Oligodendroglioma",
"criterion": "oligodendroglioma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Disease response (at least minor) to conventional chemotherapy OR",
"criterions": [
{
"exact_snippets": "Disease response (at least minor) to conventional chemotherapy",
"criterion": "disease response to conventional chemotherapy",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "at least minor"
}
]
}
]
},
{
"line": "* Recurrent disease",
"criterions": [
{
"exact_snippets": "Recurrent disease",
"criterion": "disease recurrence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Esthesioneuroblastoma:",
"criterions": [
{
"exact_snippets": "Esthesioneuroblastoma",
"criterion": "esthesioneuroblastoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Attempted complete surgical resection",
"criterions": [
{
"exact_snippets": "Attempted complete surgical resection",
"criterion": "surgical resection",
"requirements": [
{
"requirement_type": "attempted",
"expected_value": true
},
{
"requirement_type": "completeness",
"expected_value": "complete"
}
]
}
]
},
{
"line": "* Disease progression after radiotherapy",
"criterions": [
{
"exact_snippets": "Disease progression after radiotherapy",
"criterion": "disease progression",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "after radiotherapy"
}
]
}
]
},
{
"line": "* Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin",
"criterions": [
{
"exact_snippets": "Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin",
"criterion": "response to chemotherapy regimen",
"requirements": [
{
"requirement_type": "drugs involved",
"expected_value": [
"cyclophosphamide",
"etoposide",
"cisplatin"
]
}
]
}
]
},
{
"line": "* CNS lymphoma:",
"criterions": [
{
"exact_snippets": "CNS lymphoma",
"criterion": "CNS lymphoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Disease refractory to methotrexate OR",
"criterions": [
{
"exact_snippets": "Disease refractory to methotrexate",
"criterion": "disease",
"requirements": [
{
"requirement_type": "refractory to",
"expected_value": "methotrexate"
}
]
}
]
},
{
"line": "* Failure after initial treatment with methotrexate OR",
"criterions": [
{
"exact_snippets": "Failure after initial treatment with methotrexate",
"criterion": "treatment with methotrexate",
"requirements": [
{
"requirement_type": "outcome",
"expected_value": "failure after initial treatment"
}
]
}
]
},
{
"line": "* Considered at high risk for disease relapse despite initial response",
"criterions": [
{
"exact_snippets": "Considered at high risk for disease relapse",
"criterion": "risk for disease relapse",
"requirements": [
{
"requirement_type": "risk level",
"expected_value": "high"
}
]
},
{
"exact_snippets": "despite initial response",
"criterion": "initial response",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Radiographic or pathological confirmation of recurrent disease required",
"criterions": [
{
"exact_snippets": "Radiographic or pathological confirmation of recurrent disease required",
"criterion": "recurrent disease",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": [
"radiographic",
"pathological"
]
}
]
}
]
},
{
"line": "* Not eligible for other high priority national or institutional clinical studies",
"criterions": [
{
"exact_snippets": "Not eligible for other high priority national or institutional clinical studies",
"criterion": "eligibility for other high priority clinical studies",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": false
}
]
}
]
},
{
"line": "Age:",
"criterions": [
{
"exact_snippets": "Age:",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* 18 and over",
"criterions": [
{
"exact_snippets": "18 and over",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "Performance status:",
"criterions": [
{
"exact_snippets": "Performance status:",
"criterion": "performance status",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* ECOG or Zubrod 0-1",
"criterions": [
{
"exact_snippets": "ECOG or Zubrod 0-1",
"criterion": "ECOG or Zubrod performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "Life expectancy:",
"criterions": [
{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "Hematopoietic:",
"criterions": [
{
"exact_snippets": "Hematopoietic:",
"criterion": "hematopoietic system",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "Hepatic:",
"criterions": [
{
"exact_snippets": "Hepatic:",
"criterion": "hepatic function",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Renal:",
"criterions": [
{
"exact_snippets": "Renal:",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* Creatinine less than 1.5 times normal",
"criterions": [
{
"exact_snippets": "Creatinine less than 1.5 times normal",
"criterion": "creatinine",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 1.5,
"unit": "times normal"
}
}
]
}
]
},
{
"line": "Cardiovascular:",
"criterions": [
{
"exact_snippets": "Cardiovascular:",
"criterion": "cardiovascular condition",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* LVEF at least 45%",
"criterions": [
{
"exact_snippets": "LVEF at least 45%",
"criterion": "LVEF",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 45,
"unit": "%"
}
}
]
}
]
},
{
"line": "Pulmonary:",
"criterions": [
{
"exact_snippets": "Pulmonary:",
"criterion": "pulmonary",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* DLCO at least 60% predicted OR",
"criterions": [
{
"exact_snippets": "DLCO at least 60% predicted",
"criterion": "DLCO",
"requirements": [
{
"requirement_type": "predicted percentage",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "%"
}
}
]
}
]
},
{
"line": "* Approval of pulmonologist",
"criterions": [
{
"exact_snippets": "Approval of pulmonologist",
"criterion": "pulmonologist approval",
"requirements": [
{
"requirement_type": "approval",
"expected_value": true
}
]
}
]
},
{
"line": "* HIV negative",
"criterions": [
{
"exact_snippets": "HIV negative",
"criterion": "HIV status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "negative"
}
]
}
]
},
{
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Biologic therapy:",
"criterions": [
{
"exact_snippets": "Biologic therapy",
"criterion": "biologic therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Chemotherapy:",
"criterions": [
{
"exact_snippets": "Chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "see details"
}
]
}
]
},
{
"line": "* No other concurrent chemotherapy",
"criterions": [
{
"exact_snippets": "No other concurrent chemotherapy",
"criterion": "concurrent chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Endocrine therapy:",
"criterions": [
{
"exact_snippets": "Endocrine therapy",
"criterion": "endocrine therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No concurrent anticancer hormonal therapy",
"criterions": [
{
"exact_snippets": "No concurrent anticancer hormonal therapy",
"criterion": "anticancer hormonal therapy",
"requirements": [
{
"requirement_type": "concurrency",
"expected_value": false
}
]
}
]
},
{
"line": "* No concurrent steroids as antiemetics",
"criterions": [
{
"exact_snippets": "No concurrent steroids as antiemetics",
"criterion": "steroids",
"requirements": [
{
"requirement_type": "usage",
"expected_value": "not concurrent as antiemetics"
}
]
}
]
},
{
"line": "Radiotherapy:",
"criterions": [
{
"exact_snippets": "Radiotherapy",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "See Disease Characteristics"
}
]
}
]
},
{
"line": "Surgery:",
"criterions": [
{
"exact_snippets": "Surgery",
"criterion": "surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No concurrent barbiturates or acetaminophen",
"criterions": [
{
"exact_snippets": "No concurrent barbiturates",
"criterion": "barbiturates",
"requirements": [
{
"requirement_type": "concurrent use",
"expected_value": false
}
]
},
{
"exact_snippets": "No concurrent ... acetaminophen",
"criterion": "acetaminophen",
"requirements": [
{
"requirement_type": "concurrent use",
"expected_value": false
}
]
}
]
},
{
"line": "* Participation in other concurrent supportive care or gene therapy trials allowed",
"criterions": [
{
"exact_snippets": "Participation in other concurrent supportive care or gene therapy trials allowed",
"criterion": "participation in other trials",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"supportive care",
"gene therapy"
]
},
{
"requirement_type": "concurrency",
"expected_value": true
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "Other:",
"criterions": []
},
{
"line": "* Not pregnant or nursing",
"criterions": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "Other:",
"criterions": []
}
]
}