{
    "info": {
        "nct_id": "NCT00357448",
        "official_title": "Phase I Dose Escalation Study of Intraperitoneal (I.P.) ONTAK® Administered to Patients With Advanced Stage Ovarian Cancer",
        "inclusion_criteria": "* Patients with a histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or epithelial fallopian tube carcinoma\n* Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, transitional cell carcinoma, and mixed epithelial carcinoma\n* Patients with advanced stage refractory ovarian carcinoma: patients unable to achieve first complete remission (CR) with first or second line chemotherapy OR patients with disease relapse after achieving second CR\n* Patients must be 30 days out from last chemotherapy; previous chemotherapy must include a platinumbased regimen and paclitaxel (Taxol)\n* Patients must have undergone primary debulking surgery\n* Patients must have a peritoneal catheter suitable for I.P. infusion\n* White blood cell count (WBC) > 3.0 THOU/ul\n* Serum creatinine =< 2.5 mg/dL\n* ALT =< 2.5 x upper limit of normal\n* AST =< 2.5 x upper limit of normal\n* Total bilirubin =< 2.0 x upper limit of normal\n* Albumin >= 3.0 g/dL\n* Subjects must have a Performance Status Score (Zubrod/SWOG Scale) =< 2\n* Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment\n* Lymphocytes > 1.0 THOU/ul\n* Platelets >= 100 THOU/ul\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2\n* Known history of hypersensitivity to diphtheria toxin or IL-2\n* Moderate (symptomatic requiring the use of diuretics) or severe (symptomatic requiring paracentesis or other invasive intervention) ascites\n* Active autoimmune disease\n* Known history of pulmonary disease except controlled asthma\n* Known history significant cardiac disease\n* Concurrent malignancy requiring active treatment\n* Clinical or radiological evidence of acute bowel obstruction within 30 days of enrollment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with a histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or epithelial fallopian tube carcinoma",
            "criterions": [
                {
                    "exact_snippets": "histologic diagnosis of epithelial ovarian carcinoma",
                    "criterion": "epithelial ovarian carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic diagnosis of ... primary peritoneal carcinoma",
                    "criterion": "primary peritoneal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic diagnosis of ... epithelial fallopian tube carcinoma",
                    "criterion": "epithelial fallopian tube carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, transitional cell carcinoma, and mixed epithelial carcinoma",
            "criterions": [
                {
                    "exact_snippets": "histologic epithelial cell types ... Serous adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "Serous adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "endometrioid adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... mucinous adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "mucinous adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... undifferentiated carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "undifferentiated carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... clear cell adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "clear cell adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... transitional cell carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "transitional cell carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... mixed epithelial carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "mixed epithelial carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with advanced stage refractory ovarian carcinoma: patients unable to achieve first complete remission (CR) with first or second line chemotherapy OR patients with disease relapse after achieving second CR",
            "criterions": [
                {
                    "exact_snippets": "advanced stage refractory ovarian carcinoma",
                    "criterion": "ovarian carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        },
                        {
                            "requirement_type": "refractory",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to achieve first complete remission (CR) with first or second line chemotherapy",
                    "criterion": "complete remission (CR)",
                    "requirements": [
                        {
                            "requirement_type": "achievement",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "chemotherapy line",
                            "expected_value": [
                                "first",
                                "second"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "disease relapse after achieving second CR",
                    "criterion": "disease relapse",
                    "requirements": [
                        {
                            "requirement_type": "after achieving",
                            "expected_value": "second CR"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be 30 days out from last chemotherapy; previous chemotherapy must include a platinumbased regimen and paclitaxel (Taxol)",
            "criterions": [
                {
                    "exact_snippets": "Patients must be 30 days out from last chemotherapy",
                    "criterion": "time since last chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "previous chemotherapy must include a platinumbased regimen",
                    "criterion": "previous chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "platinumbased regimen"
                        }
                    ]
                },
                {
                    "exact_snippets": "previous chemotherapy must include ... paclitaxel (Taxol)",
                    "criterion": "previous chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "paclitaxel (Taxol)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have undergone primary debulking surgery",
            "criterions": [
                {
                    "exact_snippets": "Patients must have undergone primary debulking surgery",
                    "criterion": "primary debulking surgery",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have a peritoneal catheter suitable for I.P. infusion",
            "criterions": [
                {
                    "exact_snippets": "peritoneal catheter suitable for I.P. infusion",
                    "criterion": "peritoneal catheter",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": "I.P. infusion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood cell count (WBC) > 3.0 THOU/ul",
            "criterions": [
                {
                    "exact_snippets": "White blood cell count (WBC) > 3.0 THOU/ul",
                    "criterion": "white blood cell count (WBC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "THOU/ul"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine =< 2.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine =< 2.5 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT =< 2.5 x upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "ALT =< 2.5 x upper limit of normal",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST =< 2.5 x upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "AST =< 2.5 x upper limit of normal",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin =< 2.0 x upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin =< 2.0 x upper limit of normal",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin >= 3.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Albumin >= 3.0 g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have a Performance Status Score (Zubrod/SWOG Scale) =< 2",
            "criterions": [
                {
                    "exact_snippets": "Performance Status Score (Zubrod/SWOG Scale) =< 2",
                    "criterion": "Performance Status Score",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Zubrod/SWOG Scale"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment",
            "criterions": [
                {
                    "exact_snippets": "recovered from major infections",
                    "criterion": "major infections",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered from ... surgical procedures",
                    "criterion": "surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not have a significant active concurrent medical illness",
                    "criterion": "active concurrent medical illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lymphocytes > 1.0 THOU/ul",
            "criterions": [
                {
                    "exact_snippets": "Lymphocytes > 1.0 THOU/ul",
                    "criterion": "lymphocytes",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.0,
                                "unit": "THOU/ul"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets >= 100 THOU/ul",
            "criterions": [
                {
                    "exact_snippets": "Platelets >= 100 THOU/ul",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "THOU/ul"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with ONTAK (DAB389IL-2)",
                    "criterion": "prior treatment with ONTAK (DAB389IL-2)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... DAB486IL-2",
                    "criterion": "prior treatment with DAB486IL-2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of hypersensitivity to diphtheria toxin or IL-2",
            "criterions": [
                {
                    "exact_snippets": "Known history of hypersensitivity to diphtheria toxin",
                    "criterion": "hypersensitivity to diphtheria toxin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of hypersensitivity to ... IL-2",
                    "criterion": "hypersensitivity to IL-2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Moderate (symptomatic requiring the use of diuretics) or severe (symptomatic requiring paracentesis or other invasive intervention) ascites",
            "criterions": [
                {
                    "exact_snippets": "Moderate (symptomatic requiring the use of diuretics) ... ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "moderate"
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "use of diuretics"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe (symptomatic requiring paracentesis or other invasive intervention) ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "paracentesis",
                                "other invasive intervention"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of pulmonary disease except controlled asthma",
            "criterions": [
                {
                    "exact_snippets": "Known history of pulmonary disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except controlled asthma",
                    "criterion": "controlled asthma",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history significant cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "Known history significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent malignancy requiring active treatment",
            "criterions": [
                {
                    "exact_snippets": "Concurrent malignancy requiring active treatment",
                    "criterion": "concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "active treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical or radiological evidence of acute bowel obstruction within 30 days of enrollment",
            "criterions": [
                {
                    "exact_snippets": "Clinical or radiological evidence of acute bowel obstruction",
                    "criterion": "acute bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "clinical",
                                "radiological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 30 days of enrollment",
                    "criterion": "time since acute bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}