{
"info": {
"nct_id": "NCT00645060",
"official_title": "A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed advanced solid tumor for which no standard or effective treatment is available\n\n * Patients who refuse an available standard but non-curative treatment may also be eligible\n* Tumors must produce CEA as documented by either an elevated serum CEA above the upper limit of normal (ULN) or by immunohistochemical (IHC) methods\n\n * Positive CEA IHC stain is determined if more than 30% of the tumor cells have an intensity of 2+ or greater\n* Measurable disease\n* Estimated < 1/3 of liver involvement if tumor involves the liver\n* No brain or leptomeningeal involvement with cancer\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 60-100%\n* Life expectancy ≥ 3 months\n* WBC ≥ 4,000/μL\n* ANC ≥ 1,500/μL\n* Platelet count ≥ 125,000/μL\n* Creatinine ≤ 1.5 mg/dL and/or creatinine clearance > 60 mL/min\n* Bilirubin ≤ 1.5 mg/dL\n* ALT and AST ≤ 2 times ULN\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Patients currently being treated for severe infections or recovering from other intercurrent illnesses (such as poorly controlled diabetes or hypertension) are ineligible until recovery is deemed complete by the investigator\n* Serum anti-antibody testing must be negative for human anti-humanized antibodies (if patient received prior monoclonal antibody)\n* Serum HIV-negative\n* Serum hepatitis B antigen- and hepatitis C antibody-negative\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 4 weeks since prior radiotherapy, immunotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered\n* Recovered from prior major surgery\n* No prior radiotherapy to > 50% of bone marrow\n* No other concurrent chemotherapy, radiotherapy, or immunotherapy"
},
"inclusion_lines": [
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"identified_line": {
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}
}
]
},
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},
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"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
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}
}
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{
"exact_snippets": "minimum age of 18 Years",
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"identified_line": {
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"value": 120,
"unit": "Years"
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}
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"exact_snippets": "maximum age of 120 Years",
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"unit": "Years"
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],
"exclusion_lines": [],
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"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
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"exact_snippets": "DISEASE CHARACTERISTICS",
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"requirement": {
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}
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}
},
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"criterion": "treatment availability",
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"exact_snippets": "elevated serum CEA above the upper limit of normal (ULN)",
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"operator": ">",
"value": 1,
"unit": "ULN"
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}
},
{
"exact_snippets": "immunohistochemical (IHC) methods",
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}
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{
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"unit": "%"
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}
},
{
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}
}
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"condition": {
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"unit": "fraction"
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"identified_line": {
"line": "* WBC ≥ 4,000/μL",
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"exact_snippets": "WBC ≥ 4,000/μL",
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"identified_line": {
"line": "* ANC ≥ 1,500/μL",
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"exact_snippets": "ANC ≥ 1,500/μL",
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"identified_line": {
"line": "* Platelet count ≥ 125,000/μL",
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"exact_snippets": "Platelet count ≥ 125,000/μL",
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{
"identified_line": {
"line": "* Bilirubin ≤ 1.5 mg/dL",
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"exact_snippets": "Bilirubin ≤ 1.5 mg/dL",
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"identified_line": {
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},
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},
{
"identified_line": {
"line": "* Serum anti-antibody testing must be negative for human anti-humanized antibodies (if patient received prior monoclonal antibody)",
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{
"exact_snippets": "Serum anti-antibody testing must be negative for human anti-humanized antibodies",
"criterion": "serum anti-antibody testing",
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}
},
{
"exact_snippets": "if patient received prior monoclonal antibody",
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}
}
]
},
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},
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}
},
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}
},
{
"identified_line": {
"line": "* Serum HIV-negative",
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{
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}