{
    "info": {
        "nct_id": "NCT00006220",
        "official_title": "Arsenic Trioxide Alone or With ATRA (Vesanoid) for Resistant Hematologic Malignancy",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 15 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Patients with any of the following diagnoses: Acute lymphocytic leukemia OR acute myeloid leukemia Failed to achieve complete remission (CR) with induction chemotherapy OR Relapsed within one year of initial CR OR Relapsed after autologous or allogeneic transplant OR Any subsequent relapse OR Refractory following relapse CR2 or more (phase I only) Blastic phase chronic myelogenous leukemia Prior therapy allowed Myelodysplastic syndrome, including the following: Refractory anemia with excess blasts (RAEB) OR RAEB in transformation (high intermediate or high risk only) Relapsed after transplant CR2 or more (phase I only) Non-Hodgkin's lymphoma OR Hodgkin's disease Newly diagnosed or in first relapse and failed to achieve CR or partial remission after induction or salvage chemotherapy OR Second or later relapse OR Relapsed after transplant No disease that can be encompassed in a standard radiation port No asymptomatic, minimally symptomatic, or low grade lymphoma Multiple myeloma Symptomatic, progressive, or recurrent disease after treatment with alkylating agents, high dose corticosteroids, or anthracyclines OR Relapsed following transplant Not eligible for autologous or allogeneic transplant A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of \"indolent\" or \"aggressive\" lymphoma will replace the former terminology of \"low\", \"intermediate\", or \"high\" grade lymphoma. However, this protocol uses the former terminology.\n\nPATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 500/mm3* Platelet count at least 50,000/mm3* *Unless caused by marrow infiltration by tumor No congenital bleeding disorder Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 3 times ULN Renal: Creatinine clearance greater than 25 mL/min Cardiovascular: No myocardial infarction, stroke, or unstable angina within the past 12 months No uncompensated congestive heart failure Left ventricular ejection fraction at least 40% Other: No active infection HIV negative HTLV I/II negative Not pregnant Fertile patients must use effective contraception during and for 2 years following study\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Prior hydroxyurea allowed Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: Not specified Other: At least 3 weeks since prior antileukemic therapy (except leukapheresis)"
    },
    "inclusion_lines": [
        {
            "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 15 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 15 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Patients with any of the following diagnoses: Acute lymphocytic leukemia OR acute myeloid leukemia Failed to achieve complete remission (CR) with induction chemotherapy OR Relapsed within one year of initial CR OR Relapsed after autologous or allogeneic transplant OR Any subsequent relapse OR Refractory following relapse CR2 or more (phase I only) Blastic phase chronic myelogenous leukemia Prior therapy allowed Myelodysplastic syndrome, including the following: Refractory anemia with excess blasts (RAEB) OR RAEB in transformation (high intermediate or high risk only) Relapsed after transplant CR2 or more (phase I only) Non-Hodgkin's lymphoma OR Hodgkin's disease Newly diagnosed or in first relapse and failed to achieve CR or partial remission after induction or salvage chemotherapy OR Second or later relapse OR Relapsed after transplant No disease that can be encompassed in a standard radiation port No asymptomatic, minimally symptomatic, or low grade lymphoma Multiple myeloma Symptomatic, progressive, or recurrent disease after treatment with alkylating agents, high dose corticosteroids, or anthracyclines OR Relapsed following transplant Not eligible for autologous or allogeneic transplant A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of \"indolent\" or \"aggressive\" lymphoma will replace the former terminology of \"low\", \"intermediate\", or \"high\" grade lymphoma. However, this protocol uses the former terminology.",
            "criterions": [
                {
                    "exact_snippets": "Acute lymphocytic leukemia",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Acute lymphocytic leukemia"
                        }
                    ]
                },
                {
                    "exact_snippets": "acute myeloid leukemia",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "acute myeloid leukemia"
                        }
                    ]
                },
                {
                    "exact_snippets": "Failed to achieve complete remission (CR) with induction chemotherapy",
                    "criterion": "remission status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "Failed to achieve complete remission with induction chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Relapsed within one year of initial CR",
                    "criterion": "relapse status",
                    "requirements": [
                        {
                            "requirement_type": "time since CR",
                            "expected_value": "within one year"
                        }
                    ]
                },
                {
                    "exact_snippets": "Relapsed after autologous or allogeneic transplant",
                    "criterion": "relapse status",
                    "requirements": [
                        {
                            "requirement_type": "post-transplant",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any subsequent relapse",
                    "criterion": "relapse status",
                    "requirements": [
                        {
                            "requirement_type": "subsequent relapse",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Refractory following relapse CR2 or more (phase I only)",
                    "criterion": "refractory status",
                    "requirements": [
                        {
                            "requirement_type": "following relapse CR2 or more",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Blastic phase chronic myelogenous leukemia",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Blastic phase chronic myelogenous leukemia"
                        }
                    ]
                },
                {
                    "exact_snippets": "Myelodysplastic syndrome",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Myelodysplastic syndrome"
                        }
                    ]
                },
                {
                    "exact_snippets": "Refractory anemia with excess blasts (RAEB)",
                    "criterion": "subtype of myelodysplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Refractory anemia with excess blasts (RAEB)"
                        }
                    ]
                },
                {
                    "exact_snippets": "RAEB in transformation (high intermediate or high risk only)",
                    "criterion": "subtype of myelodysplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": [
                                "high intermediate",
                                "high"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Relapsed after transplant CR2 or more (phase I only)",
                    "criterion": "relapse status",
                    "requirements": [
                        {
                            "requirement_type": "post-transplant",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-Hodgkin's lymphoma",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Non-Hodgkin's lymphoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hodgkin's disease",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Hodgkin's disease"
                        }
                    ]
                },
                {
                    "exact_snippets": "Newly diagnosed or in first relapse and failed to achieve CR or partial remission after induction or salvage chemotherapy",
                    "criterion": "remission status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "Newly diagnosed or in first relapse and failed to achieve CR or partial remission after induction or salvage chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Second or later relapse",
                    "criterion": "relapse status",
                    "requirements": [
                        {
                            "requirement_type": "relapse count",
                            "expected_value": "Second or later"
                        }
                    ]
                },
                {
                    "exact_snippets": "Relapsed after transplant",
                    "criterion": "relapse status",
                    "requirements": [
                        {
                            "requirement_type": "post-transplant",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No disease that can be encompassed in a standard radiation port",
                    "criterion": "disease location",
                    "requirements": [
                        {
                            "requirement_type": "radiation port",
                            "expected_value": "cannot be encompassed"
                        }
                    ]
                },
                {
                    "exact_snippets": "No asymptomatic, minimally symptomatic, or low grade lymphoma",
                    "criterion": "lymphoma grade",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": "not asymptomatic, minimally symptomatic, or low grade"
                        }
                    ]
                },
                {
                    "exact_snippets": "Multiple myeloma",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Multiple myeloma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptomatic, progressive, or recurrent disease after treatment with alkylating agents, high dose corticosteroids, or anthracyclines",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "treatment response",
                            "expected_value": "Symptomatic, progressive, or recurrent after treatment with alkylating agents, high dose corticosteroids, or anthracyclines"
                        }
                    ]
                },
                {
                    "exact_snippets": "Relapsed following transplant",
                    "criterion": "relapse status",
                    "requirements": [
                        {
                            "requirement_type": "post-transplant",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Not eligible for autologous or allogeneic transplant",
                    "criterion": "transplant eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 500/mm3* Platelet count at least 50,000/mm3* *Unless caused by marrow infiltration by tumor No congenital bleeding disorder Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 3 times ULN Renal: Creatinine clearance greater than 25 mL/min Cardiovascular: No myocardial infarction, stroke, or unstable angina within the past 12 months No uncompensated congestive heart failure Left ventricular ejection fraction at least 40% Other: No active infection HIV negative HTLV I/II negative Not pregnant Fertile patients must use effective contraception during and for 2 years following study",
            "criterions": [
                {
                    "exact_snippets": "Age: 15 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: ECOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "ECOG"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy: Not specified",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophil count at least 500/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "minimum count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count at least 50,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "minimum count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No congenital bleeding disorder",
                    "criterion": "congenital bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin less than 2 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "maximum level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT less than 3 times ULN",
                    "criterion": "SGOT level",
                    "requirements": [
                        {
                            "requirement_type": "maximum level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine clearance greater than 25 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "minimum clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No myocardial infarction, stroke, or unstable angina within the past 12 months",
                    "criterion": "myocardial infarction, stroke, or unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "occurrence within past 12 months",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No uncompensated congestive heart failure",
                    "criterion": "uncompensated congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Left ventricular ejection fraction at least 40%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "minimum fraction",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "HTLV I/II negative",
                    "criterion": "HTLV I/II status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Fertile patients must use effective contraception during and for 2 years following study",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "requirement for fertile patients",
                            "expected_value": "must use effective contraception during and for 2 years following study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Prior hydroxyurea allowed Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: Not specified Other: At least 3 weeks since prior antileukemic therapy (except leukapheresis)",
            "criterions": [
                {
                    "exact_snippets": "Prior hydroxyurea allowed",
                    "criterion": "prior hydroxyurea",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since prior antileukemic therapy (except leukapheresis)",
                    "criterion": "prior antileukemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}