{
    "info": {
        "nct_id": "NCT01312376",
        "official_title": "A Phase-1 Trial of Adoptive Transfer of Vaccine-Primed CD3/CD28-Costimulated Autologous T-Cells Combined With Vaccine Boost and Bevacizumab for Recurrent Ovarian Fallopian Tube or Primary Peritoneal Cancer Previously Vaccinated With Autologous Tumor Vaccine",
        "inclusion_criteria": "* Subjects who have received at least one vaccine under protocol UPCC-19809 or UPCC-29810.\n* ECOG performance status 0 or 1.\n* Subject has sufficient vaccine (2 vaccine doses are sufficient)\n* Must be at least 4 weeks post-operative\n* Blood coagulation parameters: PT such that international normalized ratio (INR) is less than1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT less than1.2 times the upper limit of normal.\n* Subject must be 18 years of age or older.\n* Life expectancy of greater than 4 months.\n* Normal organ and bone marrow function as defined by: Absolute neutrophil count greater than 1,000/microliter, Platelets greater than 100,000/microliter, Hematocrit greater than 30%, AST (SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal, Bilirubin less than 2.0 mg/dL unless secondary to bile duct blockage by tumor, and Creatinine less than 1.8 mg/dL\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subjects who require or are likely to require more than a two-week course of corticosteroids for intercurrent illness. Subjects must complete therapy prior to enrollment. Topical corticosteroids should be stopped at least 2 weeks prior to enrollment and systemic corticosteroids should be stopped at least 4 weeks prior to enrollment.\n* Subjects with any acute infection that requires specific therapy. Acute therapy must have been completed at least seven days prior to study enrollment\n* Subjects with any underlying conditions, which would contraindicate therapy with, study treatment (or allergies to reagents used in this study).\n* Subjects with prior history or symptoms suggestive of partial or complete bowel obstruction.\n* Subjects receiving class III antiarrythmic medications.\n* Subjects receiving medications that might affect immune function. Additionally, H2 blockers are excluded, as are all antihistamines five days before and five days after each injection of study drug. NOTE: The following are exceptions: Proton pump Inhibitors (PPIs), NSAIDS including COX-2 inhibitors, acetaminophen.\n* Subjects who are allergic to Aspirin are excluded\n* Development of clinically significant co morbid disease that would contraindicate study therapy or confuse interpretation of study results.\n* Subjects with a History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.\n* Subjects with evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects who have received at least one vaccine under protocol UPCC-19809 or UPCC-29810.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have received at least one vaccine under protocol UPCC-19809",
                    "criterion": "vaccine under protocol UPCC-19809",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "vaccine"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received at least one vaccine under protocol ... UPCC-29810",
                    "criterion": "vaccine under protocol UPCC-29810",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "vaccine"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has sufficient vaccine (2 vaccine doses are sufficient)",
            "criterions": [
                {
                    "exact_snippets": "sufficient vaccine (2 vaccine doses are sufficient)",
                    "criterion": "vaccine doses",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "doses"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be at least 4 weeks post-operative",
            "criterions": [
                {
                    "exact_snippets": "at least 4 weeks post-operative",
                    "criterion": "post-operative period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Blood coagulation parameters: PT such that international normalized ratio (INR) is less than1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT less than1.2 times the upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "PT such that international normalized ratio (INR) is less than1.5",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PTT less than1.2 times the upper limit of normal",
                    "criterion": "PTT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.2,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must be 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "Subject must be 18 years of age or older.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of greater than 4 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of greater than 4 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal organ and bone marrow function as defined by: Absolute neutrophil count greater than 1,000/microliter, Platelets greater than 100,000/microliter, Hematocrit greater than 30%, AST (SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal, Bilirubin less than 2.0 mg/dL unless secondary to bile duct blockage by tumor, and Creatinine less than 1.8 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count greater than 1,000/microliter",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "microliter"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets greater than 100,000/microliter",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "microliter"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematocrit greater than 30%",
                    "criterion": "hematocrit",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST (SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal",
                    "criterion": "AST (SGOT)/ALT(SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "X institutional upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin less than 2.0 mg/dL unless secondary to bile duct blockage by tumor",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine less than 1.8 mg/dL",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.8,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Subjects who require or are likely to require more than a two-week course of corticosteroids for intercurrent illness. Subjects must complete therapy prior to enrollment. Topical corticosteroids should be stopped at least 2 weeks prior to enrollment and systemic corticosteroids should be stopped at least 4 weeks prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "require or are likely to require more than a two-week course of corticosteroids",
                    "criterion": "corticosteroid requirement",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Topical corticosteroids should be stopped at least 2 weeks prior to enrollment",
                    "criterion": "topical corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "cessation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic corticosteroids should be stopped at least 4 weeks prior to enrollment",
                    "criterion": "systemic corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "cessation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with any acute infection that requires specific therapy. Acute therapy must have been completed at least seven days prior to study enrollment",
            "criterions": [
                {
                    "exact_snippets": "any acute infection that requires specific therapy",
                    "criterion": "acute infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Acute therapy must have been completed at least seven days prior to study enrollment",
                    "criterion": "acute therapy completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with any underlying conditions, which would contraindicate therapy with, study treatment (or allergies to reagents used in this study).",
            "criterions": [
                {
                    "exact_snippets": "any underlying conditions, which would contraindicate therapy with, study treatment",
                    "criterion": "underlying conditions",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergies to reagents used in this study",
                    "criterion": "allergies to reagents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with prior history or symptoms suggestive of partial or complete bowel obstruction.",
            "criterions": [
                {
                    "exact_snippets": "prior history or symptoms suggestive of partial or complete bowel obstruction",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "history or symptoms",
                            "expected_value": "partial or complete"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects receiving class III antiarrythmic medications.",
            "criterions": [
                {
                    "exact_snippets": "Subjects receiving class III antiarrythmic medications.",
                    "criterion": "class III antiarrythmic medications",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects receiving medications that might affect immune function. Additionally, H2 blockers are excluded, as are all antihistamines five days before and five days after each injection of study drug. NOTE: The following are exceptions: Proton pump Inhibitors (PPIs), NSAIDS including COX-2 inhibitors, acetaminophen.",
            "criterions": [
                {
                    "exact_snippets": "Subjects receiving medications that might affect immune function.",
                    "criterion": "medications affecting immune function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "H2 blockers are excluded",
                    "criterion": "H2 blockers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "all antihistamines five days before and five days after each injection of study drug",
                    "criterion": "antihistamines",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Proton pump Inhibitors (PPIs), NSAIDS including COX-2 inhibitors, acetaminophen",
                    "criterion": "medications exceptions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who are allergic to Aspirin are excluded",
            "criterions": [
                {
                    "exact_snippets": "allergic to Aspirin",
                    "criterion": "Aspirin allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Development of clinically significant co morbid disease that would contraindicate study therapy or confuse interpretation of study results.",
            "criterions": [
                {
                    "exact_snippets": "Development of clinically significant co morbid disease",
                    "criterion": "co morbid disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "co morbid disease that would contraindicate study therapy",
                    "criterion": "co morbid disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on study therapy",
                            "expected_value": "contraindicate"
                        }
                    ]
                },
                {
                    "exact_snippets": "co morbid disease that would ... confuse interpretation of study results",
                    "criterion": "co morbid disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on study results",
                            "expected_value": "confuse interpretation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with a History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.",
            "criterions": [
                {
                    "exact_snippets": "History of bowel obstruction",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sub-occlusive disease",
                    "criterion": "sub-occlusive disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of abdominal fistula",
                    "criterion": "abdominal fistula",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal perforation",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intra-abdominal abscess",
                    "criterion": "intra-abdominal abscess",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.",
            "criterions": [
                {
                    "exact_snippets": "evidence of recto-sigmoid involvement by pelvic examination",
                    "criterion": "recto-sigmoid involvement",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bowel involvement on CT scan",
                    "criterion": "bowel involvement",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms of bowel obstruction",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "clinical symptoms",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}