{
    "info": {
        "nct_id": "NCT01205334",
        "official_title": "Phase I/II Administration of CMV (Cytomegalovirus)-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme (COGLI)",
        "inclusion_criteria": "Healthy volunteers allowed",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "INCLUSION CRITERIA:\n\n* Histopathological verification of glioblastoma multiforme (GBM: WHO grade IV) in remission (Group A) or with active disease (Group B).\n* CMV-positive GBM\n* CMV seropositive\n* Life expectancy 6 weeks or greater\n* Karnofsky/Lansky score 50 or greater\n* Patient or parent/guardian capable of providing informed consent\n* Bilirubin less than 1.5x upper limit of normal, AST less than 3x upper limit of normal, serum creatinine less than 1.5x normal and Hgb 8.0 g/dL or greater\n* Pulse oximetry of 90% or greater on room air\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom.\n* Patients should have been off other investigational antineoplastic therapy for one month prior to entry in this study.\n* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.\n\nEXCLUSION CRITERIA:\n\n* Severe intercurrent infection\n* Known HIV positivity\n* Pregnant or lactating\n* History of hypersensitivity reactions to murine protein-containing products."
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Histopathological verification of glioblastoma multiforme (GBM: WHO grade IV) in remission (Group A) or with active disease (Group B).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Histopathological verification of glioblastoma multiforme"
                    ],
                    "criterion": "glioblastoma multiforme",
                    "requirement_type": "verification",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "glioblastoma multiforme (GBM: WHO grade IV)"
                    ],
                    "criterion": "glioblastoma multiforme",
                    "requirement_type": "grade",
                    "expected_value": "WHO grade IV"
                },
                {
                    "exact_snippets": [
                        "glioblastoma multiforme",
                        "in remission"
                    ],
                    "criterion": "glioblastoma multiforme",
                    "requirement_type": "disease status",
                    "expected_value": "remission"
                },
                {
                    "exact_snippets": [
                        "glioblastoma multiforme",
                        "with active disease"
                    ],
                    "criterion": "glioblastoma multiforme",
                    "requirement_type": "disease status",
                    "expected_value": "active disease"
                }
            ]
        },
        {
            "line": "* CMV-positive GBM",
            "criterions": [
                {
                    "exact_snippets": [
                        "CMV-positive"
                    ],
                    "criterion": "CMV",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "GBM"
                    ],
                    "criterion": "GBM",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* CMV seropositive",
            "criterions": [
                {
                    "exact_snippets": [
                        "CMV seropositive"
                    ],
                    "criterion": "CMV",
                    "requirement_type": "serostatus",
                    "expected_value": "positive"
                }
            ]
        },
        {
            "line": "* Life expectancy 6 weeks or greater",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy 6 weeks or greater"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Karnofsky/Lansky score 50 or greater",
            "criterions": [
                {
                    "exact_snippets": [
                        "Karnofsky/Lansky score"
                    ],
                    "criterion": "Karnofsky/Lansky score",
                    "requirement_type": "value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 50
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patient or parent/guardian capable of providing informed consent",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient or parent/guardian capable of providing informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "capability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Bilirubin less than 1.5x upper limit of normal, AST less than 3x upper limit of normal, serum creatinine less than 1.5x normal and Hgb 8.0 g/dL or greater",
            "criterions": [
                {
                    "exact_snippets": [
                        "Bilirubin less than 1.5x upper limit of normal"
                    ],
                    "criterion": "bilirubin",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 1.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "AST less than 3x upper limit of normal"
                    ],
                    "criterion": "AST",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "serum creatinine less than 1.5x normal"
                    ],
                    "criterion": "serum creatinine",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 1.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Hgb 8.0 g/dL or greater"
                    ],
                    "criterion": "Hgb",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 8.0
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Pulse oximetry of 90% or greater on room air",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pulse oximetry",
                        "90% or greater"
                    ],
                    "criterion": "pulse oximetry",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 90
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Sexually active patients"
                    ],
                    "criterion": "sexual activity",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "must be willing to utilize one of the more effective birth control methods"
                    ],
                    "criterion": "birth control method",
                    "requirement_type": "willingness to use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "for 6 months after the CTL infusion"
                    ],
                    "criterion": "birth control method",
                    "requirement_type": "duration of use",
                    "expected_value": "6 months"
                },
                {
                    "exact_snippets": [
                        "The male partner should use a condom"
                    ],
                    "criterion": "condom use",
                    "requirement_type": "requirement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients should have been off other investigational antineoplastic therapy for one month prior to entry in this study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "off other investigational antineoplastic therapy for one month prior to entry"
                    ],
                    "criterion": "investigational antineoplastic therapy",
                    "requirement_type": "cessation period",
                    "expected_value": {
                        "operator": ">=",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Informed consent explained to, understood by and signed by patient/guardian"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "signed",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patient/guardian given copy of informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "copy given",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Severe intercurrent infection",
            "criterions": [
                {
                    "exact_snippets": [
                        "Severe intercurrent infection"
                    ],
                    "criterion": "intercurrent infection",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                }
            ]
        },
        {
            "line": "* Known HIV positivity",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known HIV positivity"
                    ],
                    "criterion": "HIV",
                    "requirement_type": "positivity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of hypersensitivity reactions to murine protein-containing products.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of hypersensitivity reactions"
                    ],
                    "criterion": "hypersensitivity reactions",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "murine protein-containing products"
                    ],
                    "criterion": "murine protein-containing products",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        }
    ]
}