{
    "info": {
        "nct_id": "NCT00089427",
        "official_title": "Phase I Study of Convection Enhanced Delivery (CED) of IL13-PE38QQR Infusion After Resection Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma",
        "inclusion_criteria": "* Patients must be ≥18 years old.\n* Patients must have undergone a gross total resection of the solid contrast-enhancing lesion(s) > 1.0 cm in diameter.\n* Patients must be able to have catheters placed within 14 days of tumor resection (including a planned Gross Total Resection following an initial biopsy or subtotal resection)\n* Patients must have histopathologic confirmation of malignant glioma from resection specimen. Diagnosis must be consistent with either GBM, AA, or malignant mixed OA.\n* Patients must be in adequate general condition and meet the following criteria:\n* a. Karnofsky Performance Scale score ≥ 70\n* b. Adequate hematologic status:\n\n  * Absolute neutrophil count ≥ 1,500/mm³\n  * Hemoglobin ≥ 10 gm/dL\n  * Platelets ≥ 100,000/mm³\n  * PT & aPTT within institutional limits of normal\n* Female patients must not be pregnant or breast-feeding.\n* Patients must practice an effective method of birth control during the study and for 60 days beyond the last day of infusion.\n* Patients must understand the investigational nature of this study and its potential risks and benefits, and sign an approved written informed consent prior to performance of any study-specific procedure.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with residual contrast-enhancing tumor crossing the midline, multifocal tumor not amenable to gross total resection or non-parenchymal tumor dissemination (e.g., subependymal or leptomeningeal).\n* Patients with clinically significant increased ICP (e.g., impending herniation), uncontrolled seizures or requirement for immediate palliative treatment.\n* Patients who have received any prior anti-tumor treatment (other than corticosteroids) including any investigational agents.\n* Patients with any metallic prosthesis that would prevent MRI and/or MRS scanning procedures of the brain.\n* Patients unwilling or unable to follow protocol requirements.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must be ≥18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be ≥18 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have undergone a gross total resection of the solid contrast-enhancing lesion(s) > 1.0 cm in diameter.",
            "criterions": [
                {
                    "exact_snippets": "undergone a gross total resection of the solid contrast-enhancing lesion(s)",
                    "criterion": "gross total resection of solid contrast-enhancing lesion(s)",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion(s) > 1.0 cm in diameter",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to have catheters placed within 14 days of tumor resection (including a planned Gross Total Resection following an initial biopsy or subtotal resection)",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to have catheters placed",
                    "criterion": "catheter placement ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days of tumor resection",
                    "criterion": "catheter placement timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have histopathologic confirmation of malignant glioma from resection specimen. Diagnosis must be consistent with either GBM, AA, or malignant mixed OA.",
            "criterions": [
                {
                    "exact_snippets": "histopathologic confirmation of malignant glioma",
                    "criterion": "malignant glioma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis must be consistent with either GBM, AA, or malignant mixed OA",
                    "criterion": "diagnosis consistency",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": [
                                "GBM",
                                "AA",
                                "malignant mixed OA"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be in adequate general condition and meet the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "adequate general condition",
                    "criterion": "general condition",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* a. Karnofsky Performance Scale score ≥ 70",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Scale score ≥ 70",
                    "criterion": "Karnofsky Performance Scale score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* b. Adequate hematologic status:",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic status",
                    "criterion": "hematologic status",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/mm³",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/mm³",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 10 gm/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 10 gm/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "gm/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100,000/mm³",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100,000/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PT & aPTT within institutional limits of normal",
            "criterions": [
                {
                    "exact_snippets": "PT ... within institutional limits of normal",
                    "criterion": "PT",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within institutional limits of normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "aPTT within institutional limits of normal",
                    "criterion": "aPTT",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within institutional limits of normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients must not be pregnant or breast-feeding.",
            "criterions": [
                {
                    "exact_snippets": "Female patients must not be pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients must not be ... breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must practice an effective method of birth control during the study and for 60 days beyond the last day of infusion.",
            "criterions": [
                {
                    "exact_snippets": "Patients must practice an effective method of birth control",
                    "criterion": "birth control",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for 60 days beyond the last day of infusion",
                    "criterion": "duration of birth control",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 60 days beyond the last day of infusion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must understand the investigational nature of this study and its potential risks and benefits, and sign an approved written informed consent prior to performance of any study-specific procedure.",
            "criterions": [
                {
                    "exact_snippets": "Patients must understand the investigational nature of this study and its potential risks and benefits",
                    "criterion": "understanding of study nature and risks/benefits",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign an approved written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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 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": [
        {
            "line": "* Patients with residual contrast-enhancing tumor crossing the midline, multifocal tumor not amenable to gross total resection or non-parenchymal tumor dissemination (e.g., subependymal or leptomeningeal).",
            "criterions": [
                {
                    "exact_snippets": "residual contrast-enhancing tumor crossing the midline",
                    "criterion": "residual contrast-enhancing tumor crossing the midline",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "multifocal tumor not amenable to gross total resection",
                    "criterion": "multifocal tumor",
                    "requirements": [
                        {
                            "requirement_type": "amenability to gross total resection",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-parenchymal tumor dissemination (e.g., subependymal or leptomeningeal)",
                    "criterion": "non-parenchymal tumor dissemination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with clinically significant increased ICP (e.g., impending herniation), uncontrolled seizures or requirement for immediate palliative treatment.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant increased ICP",
                    "criterion": "increased intracranial pressure (ICP)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled seizures",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "requirement for immediate palliative treatment",
                    "criterion": "palliative treatment",
                    "requirements": [
                        {
                            "requirement_type": "urgency",
                            "expected_value": "immediate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received any prior anti-tumor treatment (other than corticosteroids) including any investigational agents.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received any prior anti-tumor treatment (other than corticosteroids)",
                    "criterion": "prior anti-tumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including any investigational agents",
                    "criterion": "prior investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with any metallic prosthesis that would prevent MRI and/or MRS scanning procedures of the brain.",
            "criterions": [
                {
                    "exact_snippets": "any metallic prosthesis that would prevent MRI and/or MRS scanning procedures of the brain",
                    "criterion": "metallic prosthesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unwilling or unable to follow protocol requirements.",
            "criterions": [
                {
                    "exact_snippets": "Patients unwilling ... to follow protocol requirements.",
                    "criterion": "willingness to follow protocol requirements",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients ... unable to follow protocol requirements.",
                    "criterion": "ability to follow protocol requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}