{
"info": {
"nct_id": "NCT00002773",
"official_title": "A CLINICAL TRIAL FOR PANCREAS CANCER USING ACTIVE INTRALYMPHATIC IMMUNOTHERAPY WITH INTERFERON-TREATED PANCREAS CANCER TISSUE CULTURE CELLS, GMCSF, AND LOW-DOSE CYCLOPHOSPHAMIDE",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas that is locoregionally active or metastatic and not amenable to cure or long-term control by surgery, radiotherapy, or chemotherapy No brain metastases refractory to irradiation or surgery\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 OR Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prior or concurrent significant cardiovascular disease Pulmonary: No prior or concurrent significant pulmonary disease Other: No AIDS HIV negative No prior or concurrent autoimmune disease No other concurrent major medical illness Not pregnant or nursing Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent chronic steroid therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other prior therapy"
},
"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 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": [],
"miscellaneous_lines": [
{
"line": "DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas that is locoregionally active or metastatic and not amenable to cure or long-term control by surgery, radiotherapy, or chemotherapy No brain metastases refractory to irradiation or surgery",
"criterions": [
{
"exact_snippets": "Histologically confirmed adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma of the pancreas",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "locoregionally active or metastatic",
"criterion": "adenocarcinoma of the pancreas",
"requirements": [
{
"requirement_type": "activity",
"expected_value": [
"locoregionally active",
"metastatic"
]
}
]
},
{
"exact_snippets": "not amenable to cure or long-term control by surgery, radiotherapy, or chemotherapy",
"criterion": "adenocarcinoma of the pancreas",
"requirements": [
{
"requirement_type": "amenability to cure or long-term control",
"expected_value": false
}
]
},
{
"exact_snippets": "No brain metastases refractory to irradiation or surgery",
"criterion": "brain metastases",
"requirements": [
{
"requirement_type": "refractory to irradiation or surgery",
"expected_value": false
}
]
}
]
},
{
"line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 OR Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prior or concurrent significant cardiovascular disease Pulmonary: No prior or concurrent significant pulmonary disease Other: No AIDS HIV negative No prior or concurrent autoimmune disease No other concurrent major medical illness Not pregnant or nursing Fertile patients must use effective contraception",
"criterions": [
{
"exact_snippets": "Age: 18 and over",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "Performance status: ECOG 0-3 OR Karnofsky 60-100%",
"criterion": "performance status",
"requirements": [
{
"requirement_type": "ECOG",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "ECOG"
},
{
"operator": "<=",
"value": 3,
"unit": "ECOG"
}
]
}
},
{
"requirement_type": "Karnofsky",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
]
},
{
"exact_snippets": "Life expectancy: At least 3 months",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
},
{
"exact_snippets": "Cardiovascular: No prior or concurrent significant cardiovascular disease",
"criterion": "cardiovascular disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Pulmonary: No prior or concurrent significant pulmonary disease",
"criterion": "pulmonary disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Other: No AIDS",
"criterion": "AIDS",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "HIV negative",
"criterion": "HIV status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "No prior or concurrent autoimmune disease",
"criterion": "autoimmune disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No other concurrent major medical illness",
"criterion": "major medical illness",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Not pregnant or nursing",
"criterion": "pregnancy or nursing status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "not pregnant or nursing"
}
]
},
{
"exact_snippets": "Fertile patients must use effective contraception",
"criterion": "contraception use",
"requirements": [
{
"requirement_type": "requirement for fertile patients",
"expected_value": "must use effective contraception"
}
]
}
]
},
{
"line": "PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent chronic steroid therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other prior therapy",
"criterions": [
{
"exact_snippets": "At least 4 weeks since prior chemotherapy",
"criterion": "prior chemotherapy",
"requirements": [
{
"requirement_type": "time since",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "No concurrent chronic steroid therapy",
"criterion": "concurrent chronic steroid therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "At least 4 weeks since prior radiotherapy",
"criterion": "prior radiotherapy",
"requirements": [
{
"requirement_type": "time since",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "At least 4 weeks since other prior therapy",
"criterion": "other prior therapy",
"requirements": [
{
"requirement_type": "time since",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}