{
"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": ""
},
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"identified_line": {
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"unit": "vaccine"
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}
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"expected_value": false
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"exact_snippets": "systemic corticosteroids should be stopped at least 4 weeks prior to enrollment",
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}
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],
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}
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}
},
{
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}
}
]
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},
{
"exact_snippets": "all antihistamines five days before and five days after each injection of study drug",
"criterion": "antihistamines",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Subjects who are allergic to Aspirin are excluded",
"criterions": [
{
"exact_snippets": "allergic to Aspirin",
"criterion": "Aspirin allergy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
},
{
"exact_snippets": "co morbid disease that would contraindicate study therapy",
"criterion": "co morbid disease",
"requirement": {
"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",
"requirement": {
"requirement_type": "impact on study results",
"expected_value": "confuse interpretation"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "sub-occlusive disease",
"criterion": "sub-occlusive disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of abdominal fistula",
"criterion": "abdominal fistula",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "gastrointestinal perforation",
"criterion": "gastrointestinal perforation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "intra-abdominal abscess",
"criterion": "intra-abdominal abscess",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "bowel involvement on CT scan",
"criterion": "bowel involvement",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "clinical symptoms of bowel obstruction",
"criterion": "bowel obstruction",
"requirement": {
"requirement_type": "clinical symptoms",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}