{
    "info": {
        "nct_id": "NCT00634231",
        "official_title": "A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors",
        "inclusion_criteria": "* Patients must be 3 years of age or older\n* Patients must be planning to undergo standard of care treatment with surgery and radiation therapy.\n* Patients must have malignant glioma or recurrent ependymoma\n* Tumor must be accessible for injection and must not be located in the brainstem or deep midbrain\n* Performance Score: Karnofsky ≥60% if >10y/o, Lansky ≥60 if ≤10y/o\n* Bone Marrow Function: Patients must have adequate bone marrow function defined as a peripheral absolute neutrophil count ≥ 1000/µl, platelet count ≥ 100,000/µl (transfusion independent) and hemoglobin ≥ 8.0 gm/dL\n* Renal Function: Patients must have serum creatinine ≤ 1.5 times upper limit of institutional normal for age and/or GFR ≥ 70 mL/min/1.73 m2.\n* Hepatic Function: Bilirubin ≤ 1.5 times institutional normal; SGPT (ALT) < 3 times institutional normal\n* Serum electrolyte values (sodium, potassium, magnesium, calcium) must be checked prior to enrollment and clinically significant abnormalities corrected prior to surgery/AdV-tk injection\n* Patients with seizure disorder may be enrolled if well controlled\n* Signed informed consent according to institutional guidelines must be obtained\nHealthy volunteers allowed\nMust have minimum age of 3 Years\nMust have maximum age of 21 Years",
        "exclusion_criteria": "* Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection\n* Patients on immunosuppressive drugs (with exception of corticosteroid)\n* Known history of HIV or underlying immunodeficiency\n* Patients with acute infections (viral, bacterial or fungal infections requiring therapy)\n* Pregnant or breast-feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy\n* Other serious co-morbid illness or compromised organ function\n* No other investigational anti-tumor agents within 30 days prior to study entry or during active participation in the study (defined as from study entry until tumor progression)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must be 3 years of age or older",
            "criterions": [
                {
                    "exact_snippets": "3 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be planning to undergo standard of care treatment with surgery and radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be planning to undergo standard of care treatment with surgery",
                    "criterion": "standard of care treatment with surgery",
                    "requirements": [
                        {
                            "requirement_type": "planning",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must be planning to undergo standard of care treatment with ... radiation therapy",
                    "criterion": "standard of care treatment with radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "planning",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have malignant glioma or recurrent ependymoma",
            "criterions": [
                {
                    "exact_snippets": "malignant glioma",
                    "criterion": "malignant glioma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent ependymoma",
                    "criterion": "recurrent ependymoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance Score: Karnofsky ≥60% if >10y/o, Lansky ≥60 if ≤10y/o",
            "criterions": [
                {
                    "exact_snippets": "Performance Score: Karnofsky ≥60% if >10y/o",
                    "criterion": "Karnofsky Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 10,
                                        "unit": "y/o"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance Score: ... Lansky ≥60 if ≤10y/o",
                    "criterion": "Lansky Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "y/o"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": ""
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bone Marrow Function: Patients must have adequate bone marrow function defined as a peripheral absolute neutrophil count ≥ 1000/µl, platelet count ≥ 100,000/µl (transfusion independent) and hemoglobin ≥ 8.0 gm/dL",
            "criterions": [
                {
                    "exact_snippets": "peripheral absolute neutrophil count ≥ 1000/µl",
                    "criterion": "peripheral absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "µl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥ 100,000/µl (transfusion independent)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "µl"
                            }
                        },
                        {
                            "requirement_type": "transfusion independence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥ 8.0 gm/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "gm/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal Function: Patients must have serum creatinine ≤ 1.5 times upper limit of institutional normal for age and/or GFR ≥ 70 mL/min/1.73 m2.",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine ≤ 1.5 times upper limit of institutional normal for age",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper limit of institutional normal for age"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "GFR ≥ 70 mL/min/1.73 m2",
                    "criterion": "GFR",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "mL/min/1.73 m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatic Function: Bilirubin ≤ 1.5 times institutional normal; SGPT (ALT) < 3 times institutional normal",
            "criterions": [
                {
                    "exact_snippets": "Hepatic Function: Bilirubin ≤ 1.5 times institutional normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times institutional normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic Function: ... SGPT (ALT) < 3 times institutional normal",
                    "criterion": "SGPT (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times institutional normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum electrolyte values (sodium, potassium, magnesium, calcium) must be checked prior to enrollment and clinically significant abnormalities corrected prior to surgery/AdV-tk injection",
            "criterions": [
                {
                    "exact_snippets": "Serum electrolyte values (sodium, potassium, magnesium, calcium) must be checked",
                    "criterion": "serum electrolyte values",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant abnormalities corrected",
                    "criterion": "clinically significant abnormalities in serum electrolyte values",
                    "requirements": [
                        {
                            "requirement_type": "correction",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with seizure disorder may be enrolled if well controlled",
            "criterions": [
                {
                    "exact_snippets": "Patients with seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if well controlled",
                    "criterion": "seizure disorder control",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "well controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent according to institutional guidelines must be obtained",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent ... must be obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 3 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 3 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 21 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection",
            "criterions": [
                {
                    "exact_snippets": "Prior or ongoing liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known cirrhosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B or C infection",
                    "criterion": "hepatitis B or C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "distant history of resolved hepatitis A infection",
                    "criterion": "resolved hepatitis A infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients on immunosuppressive drugs (with exception of corticosteroid)",
            "criterions": [
                {
                    "exact_snippets": "Patients on immunosuppressive drugs",
                    "criterion": "immunosuppressive drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(with exception of corticosteroid)",
                    "criterion": "corticosteroid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of HIV or underlying immunodeficiency",
            "criterions": [
                {
                    "exact_snippets": "Known history of HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "underlying immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with acute infections (viral, bacterial or fungal infections requiring therapy)",
            "criterions": [
                {
                    "exact_snippets": "acute infections (viral, bacterial or fungal infections requiring therapy)",
                    "criterion": "acute infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "viral",
                                "bacterial",
                                "fungal"
                            ]
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients of childbearing age",
                    "criterion": "female patients of childbearing age",
                    "requirements": [
                        {
                            "requirement_type": "pregnancy test result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum or urine pregnancy test within 1 week of beginning therapy",
                    "criterion": "pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 1 week of beginning therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other serious co-morbid illness or compromised organ function",
            "criterions": [
                {
                    "exact_snippets": "serious co-morbid illness",
                    "criterion": "co-morbid illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "compromised organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "compromised"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other investigational anti-tumor agents within 30 days prior to study entry or during active participation in the study (defined as from study entry until tumor progression)",
            "criterions": [
                {
                    "exact_snippets": "No other investigational anti-tumor agents within 30 days prior to study entry",
                    "criterion": "use of investigational anti-tumor agents",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 30 days prior to study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "No other investigational anti-tumor agents ... during active participation in the study (defined as from study entry until tumor progression)",
                    "criterion": "use of investigational anti-tumor agents",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during active participation in the study (defined as from study entry until tumor progression)"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Tumor must be accessible for injection and must not be located in the brainstem or deep midbrain",
            "criterions": [
                {
                    "exact_snippets": "Tumor must be accessible for injection",
                    "criterion": "tumor accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": "for injection"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor ... must not be located in the brainstem",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "not in brainstem"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor ... must not be located in the ... deep midbrain",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "not in deep midbrain"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}