{
    "info": {
        "nct_id": "NCT01183065",
        "official_title": "A Multi-Institution Phase II Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)",
        "inclusion_criteria": "* Patients must have histopathologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck, including unknown primary squamous cell carcinomas of the neck. Confirmation of biopsy/diagnosis will be performed at MSKCC or at participating sites (NYU Cancer Institute/NYU Medical Center/ Bellevue Hospital Center).\n* Patients must be at least 18 years of age.\n* ECOG performance status must be ≥ 0 or 1.\n* Disease must be measurable by RECIST version 1.1 criteria.\n* Patients must have been previously treated with systemic chemotherapy (i.e., chemotherapy and/or targeted therapies such as cetuximab for recurrent/metastatic HNSCC,.\n* At least four weeks must have elapsed from previous radiation therapy. Patients must have recovered from the acute toxic effects of treatment prior to study enrollment.\n* Patients must have adequate organ function, as follows:\n\nAdequate bone marrow reserve: absolute neutrophil count (ANC) > 1,000 cells/mm3, platelets > 100,000 cells/mm3, and hemoglobin > 9 g/dL Hepatic: AST and ALT ≤ 3 X upper limit of normal (ULN); AST and ALT ≤ 5 X ULN if liver metastasis present; Total bilirubin ≤ 1.5 x ULN unless Gilbert's disease is present Renal: Serum creatinine ≤ 1.5 mg/dL or creatinine clearance (by either 24 hour urine collection or Cockcroft-Gault equation) > or = to 55 ml/min\n\n* Both women and men and members of all races and ethnic groups are eligible for this trial.\n* Women of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Both men and women must agree to use a reliable method of birth control until 30 days following the last dose of study drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of any brain metastases unless resected with no evidence for > 12 weeks and not on steroids\n* Women who are lactating\n* Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis\n* Patients who have undergone an allogeneic stem cell transplant",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have histopathologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck, including unknown primary squamous cell carcinomas of the neck. Confirmation of biopsy/diagnosis will be performed at MSKCC or at participating sites (NYU Cancer Institute/NYU Medical Center/ Bellevue Hospital Center).",
            "criterions": [
                {
                    "exact_snippets": "histopathologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck",
                    "criterion": "squamous cell carcinoma of the head and neck",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unknown primary squamous cell carcinomas of the neck",
                    "criterion": "unknown primary squamous cell carcinomas of the neck",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be at least 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status must be ≥ 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status must be ≥ 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease must be measurable by RECIST version 1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "Disease must be measurable by RECIST version 1.1 criteria.",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have been previously treated with systemic chemotherapy (i.e., chemotherapy and/or targeted therapies such as cetuximab for recurrent/metastatic HNSCC,.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have been previously treated with systemic chemotherapy",
                    "criterion": "previous treatment with systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy and/or targeted therapies such as cetuximab",
                    "criterion": "previous treatment with chemotherapy or targeted therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent/metastatic HNSCC",
                    "criterion": "recurrent/metastatic HNSCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least four weeks must have elapsed from previous radiation therapy. Patients must have recovered from the acute toxic effects of treatment prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "At least four weeks must have elapsed from previous radiation therapy.",
                    "criterion": "time since previous radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have recovered from the acute toxic effects of treatment",
                    "criterion": "recovery from acute toxic effects of treatment",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequate organ function, as follows:",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Adequate bone marrow reserve: absolute neutrophil count (ANC) > 1,000 cells/mm3, platelets > 100,000 cells/mm3, and hemoglobin > 9 g/dL Hepatic: AST and ALT ≤ 3 X upper limit of normal (ULN); AST and ALT ≤ 5 X ULN if liver metastasis present; Total bilirubin ≤ 1.5 x ULN unless Gilbert's disease is present Renal: Serum creatinine ≤ 1.5 mg/dL or creatinine clearance (by either 24 hour urine collection or Cockcroft-Gault equation) > or = to 55 ml/min",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count (ANC) > 1,000 cells/mm3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets > 100,000 cells/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin > 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤ 3 X upper limit of normal (ULN)",
                    "criterion": "AST and ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤ 5 X ULN if liver metastasis present",
                    "criterion": "AST and ALT with liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 x ULN unless Gilbert's disease is present",
                    "criterion": "Total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 mg/dL",
                    "criterion": "Serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance (by either 24 hour urine collection or Cockcroft-Gault equation) > or = to 55 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Both women and men and members of all races and ethnic groups are eligible for this trial.",
            "criterions": [
                {
                    "exact_snippets": "women and men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": [
                                "female",
                                "male"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "members of all races and ethnic groups",
                    "criterion": "race and ethnicity",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "all"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Both men and women must agree to use a reliable method of birth control until 30 days following the last dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test within 14 days of treatment",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days of treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Both men and women must agree to use a reliable method of birth control until 30 days following the last dose of study drug",
                    "criterion": "birth control",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "until 30 days following the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* History of any brain metastases unless resected with no evidence for > 12 weeks and not on steroids",
            "criterions": [
                {
                    "exact_snippets": "History of any brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless resected",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "resection",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence for > 12 weeks",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not on steroids",
                    "criterion": "steroid use",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are lactating",
            "criterions": [
                {
                    "exact_snippets": "Women who are lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis",
            "criterions": [
                {
                    "exact_snippets": "Other active malignancy",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis",
                    "criterion": "indolent malignancies",
                    "requirements": [
                        {
                            "requirement_type": "interference with treatment and safety analysis",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have undergone an allogeneic stem cell transplant",
            "criterions": [
                {
                    "exact_snippets": "Patients who have undergone an allogeneic stem cell transplant",
                    "criterion": "allogeneic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}