{
"info": {
"nct_id": "NCT00014131",
"official_title": "Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 16 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed renal cell carcinoma\n\n * Stage III or IV disease involving invasions beyond Gerota's fascia, regional lymph node involvement, or distant metastases OR\n * Recurrent disease involving lymph node metastases or soft tissue nodules\n* Measurable disease by anatomic-based radiological tests (unless no evidence of disease as documented by prior surgery)\n* Planned resection of tumor to establish an autologous tumor cell line\n* No active CNS metastases such as brain metastases, spinal cord compression, or leptomeningeal disease\n\n * Prior brain metastases or spinal cord compression allowed provided there is radiographic evidence of lack of progression and no requirement for pharmacologic doses of corticosteroids\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 16 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 4 months\n\nHematopoietic:\n\n* Hematocrit greater than 25%\n* Platelet count greater than 100,000/mm3\n* No ongoing transfusion requirements\n* No active blood clotting or bleeding diathesis\n\nHepatic:\n\n* Bilirubin no greater than 2.0 mg/dL\n* Albumin at least 3.0 g/dL\n* No significant hepatic dysfunction\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n* No significant renal dysfunction\n\nCardiovascular:\n\n* No underlying cardiac disease associated with New York Heart Association class III or IV heart function\n* No unstable angina related to atherosclerotic cardiovascular disease\n\nOther:\n\n* No other malignancy within the past 5 years except carcinoma in situ, basal cell or localized squamous cell skin cancer, or localized prostate cancer\n* No active infection\n* No other active medical condition that could be eminently life threatening\n* Not pregnant\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Other prior putative vaccines allowed\n* Recovered from prior biologic therapy\n* No concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36%\n\nChemotherapy:\n\n* At least 3 weeks since prior chemotherapy and recovered\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* No concurrent corticosteroids\n\nRadiotherapy:\n\n* At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and recovered\n* No concurrent radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* Recovered from prior surgery\n\nOther:\n\n* Concurrent bisphosphonates allowed for patients with lytic bone metastases\n* No concurrent digoxin or other medications designed to improve cardiac output\n* No other concurrent anticancer therapy or investigational therapy"
},
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"line": "DISEASE CHARACTERISTICS:",
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}
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}
}
]
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]
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}
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},
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},
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},
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}
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"then_criteria": null,
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}
},
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}
]
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},
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}
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}
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}
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}
},
{
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},
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}
]
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