{
    "info": {
        "nct_id": "NCT00003194",
        "official_title": "A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid Tumors.",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 1 Year\nMust have maximum age of 30 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically proven recurrent or refractory pediatric solid tumor\n* Bone marrow metastases allowed\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 1 to 30\n\nPerformance status:\n\n* 0-2\n\nLife expectancy:\n\n* At least 2 months\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,000/mm3\n* Platelet count at least 100,000/mm3 (transfusion independent)\n* Hemoglobin at least 10 g/dL (RBC transfusion allowed)\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times normal\n* SGOT no greater than 2.5 times normal\n\nRenal:\n\n* Adequate renal function as defined by one of the following:\n\n  * GFR by creatinine clearance\n  * Radioisotope GFR\n  * Iothalamate at least 70 mL/min\n\nCardiovascular:\n\n* Adequate cardiac function as defined by one of the following:\n\n  * Ejection fraction at least 55% by MUGA\n  * Fractional shortening at least 28% by echocardiogram\n\nNeurologic:\n\n* Adequate CNS function as defined by:\n\n  * Seizure disorder, if present, controlled by anticonvulsants\n  * CNS toxicity no greater than grade 2\n\nOther:\n\n* No uncontrolled infections\n* Not pregnant or nursing\n* No allergy to platinum compounds\n* No history of allergy to etoposide (unless mobilization phase not required)\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Recovered from prior immunotherapy\n* At least 1 week since prior cytokines\n* At least 3 months since prior bone marrow or peripheral blood stem cell transplantation\n* No concurrent immunomodulator\n* No concurrent cytokines\n\nChemotherapy:\n\n* At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered\n* No prior thiotepa\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Recovered from prior radiotherapy\n* At least 6 months since prior total body irradiation conditioning\n* No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow\n\nSurgery:\n\n* Not specified"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 1 Year",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 1 Year",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "Year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 1 Year",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "Year"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 30 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 30 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 30 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "* Bone marrow metastases allowed",
                "criterions": [
                    {
                        "exact_snippets": "Bone marrow metastases allowed",
                        "criterion": "bone marrow metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Bone marrow metastases allowed",
                        "criterion": "bone marrow metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Age:",
                "criterions": [
                    {
                        "exact_snippets": "Age:",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age:",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* 1 to 30",
                "criterions": [
                    {
                        "exact_snippets": "1 to 30",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "1 to 30",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Performance status:",
                "criterions": [
                    {
                        "exact_snippets": "Performance status:",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Performance status:",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* 0-2",
                "criterions": [
                    {
                        "exact_snippets": "0-2",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "0-2",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Life expectancy:",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least 2 months",
                "criterions": [
                    {
                        "exact_snippets": "At least 2 months",
                        "criterion": "duration",
                        "requirement": {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least 2 months",
                        "criterion": "duration",
                        "requirement": {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hematopoietic:",
                "criterions": [
                    {
                        "exact_snippets": "Hematopoietic:",
                        "criterion": "hematopoietic system",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hematopoietic:",
                        "criterion": "hematopoietic system",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count at least 1,000/mm3",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count at least 1,000/mm3",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "mm3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count at least 1,000/mm3",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "mm3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count at least 100,000/mm3 (transfusion independent)",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count at least 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "transfusion independent",
                        "criterion": "transfusion independence",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count at least 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "transfusion independent",
                        "criterion": "transfusion independence",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin at least 10 g/dL (RBC transfusion allowed)",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin at least 10 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "RBC transfusion allowed",
                        "criterion": "RBC transfusion",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin at least 10 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "RBC transfusion allowed",
                        "criterion": "RBC transfusion",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hepatic:",
                "criterions": [
                    {
                        "exact_snippets": "Hepatic:",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hepatic:",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bilirubin no greater than 1.5 times normal",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin no greater than 1.5 times normal",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Bilirubin no greater than 1.5 times normal",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times normal"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* SGOT no greater than 2.5 times normal",
                "criterions": [
                    {
                        "exact_snippets": "SGOT no greater than 2.5 times normal",
                        "criterion": "SGOT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "SGOT no greater than 2.5 times normal",
                        "criterion": "SGOT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times normal"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Renal:",
                "criterions": [
                    {
                        "exact_snippets": "Renal:",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Renal:",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate renal function as defined by one of the following:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Adequate renal function",
                                "criterion": "renal function",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* GFR by creatinine clearance",
                "criterions": [
                    {
                        "exact_snippets": "GFR by creatinine clearance",
                        "criterion": "GFR",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "creatinine clearance"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "GFR by creatinine clearance",
                        "criterion": "GFR",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "creatinine clearance"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Radioisotope GFR",
                "criterions": [
                    {
                        "exact_snippets": "Radioisotope GFR",
                        "criterion": "radioisotope GFR",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Radioisotope GFR",
                        "criterion": "radioisotope GFR",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Iothalamate at least 70 mL/min",
                "criterions": [
                    {
                        "exact_snippets": "Iothalamate at least 70 mL/min",
                        "criterion": "iothalamate clearance",
                        "requirement": {
                            "requirement_type": "clearance rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Iothalamate at least 70 mL/min",
                        "criterion": "iothalamate clearance",
                        "requirement": {
                            "requirement_type": "clearance rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Cardiovascular:",
                "criterions": [
                    {
                        "exact_snippets": "Cardiovascular:",
                        "criterion": "cardiovascular condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Cardiovascular:",
                        "criterion": "cardiovascular condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate cardiac function as defined by one of the following:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate cardiac function",
                        "criterion": "cardiac function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Adequate cardiac function",
                        "criterion": "cardiac function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ejection fraction at least 55% by MUGA",
                "criterions": [
                    {
                        "exact_snippets": "Ejection fraction at least 55% by MUGA",
                        "criterion": "ejection fraction",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Ejection fraction at least 55% by MUGA",
                        "criterion": "ejection fraction",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "MUGA"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ejection fraction at least 55% by MUGA",
                        "criterion": "ejection fraction",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Ejection fraction at least 55% by MUGA",
                        "criterion": "ejection fraction",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "MUGA"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Fractional shortening at least 28% by echocardiogram",
                "criterions": [
                    {
                        "exact_snippets": "Fractional shortening at least 28% by echocardiogram",
                        "criterion": "fractional shortening",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Fractional shortening at least 28% by echocardiogram",
                        "criterion": "fractional shortening",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
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                    "exact_snippets": "No prior thiotepa",
                    "criterion": "thiotepa treatment",
                    "requirement": {
                        "requirement_type": "prior treatment",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No other concurrent chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "No other concurrent chemotherapy",
                        "criterion": "concurrent chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No other concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ]
}