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This study examined a vaccine therapy (autologous dendritic cell-adenovirus p53 vaccine) given after chemotherapy (Carboplatin and Etoposide) in patients with extensive-stage small cell lung cancer. Patients aged 18 and over with histologically confirmed extensive-stage small cell lung cancer could take part. The study was carried out in Phase 1/Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS: * Histologically confirmed small cell lung cancer * Extensive stage disease * Measurable disease * No uncontrolled central nervous system (CNS) metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * Not specified Hematopoietic * White blood count (WBC) greater than 3,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hematocrit greater than 25% Hepatic * Bilirubin less than 2.0 mg/dL Renal * Creatinine less than 2.0 mg/dL Immunologic * HIV negative * No serious ongoing infection * No pre-existing immunodeficiency * No known pre-existing autoimmune disorder Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * At least 4 weeks since prior steroids (before vaccination) * No concurrent chronic steroids (during vaccination) Radiotherapy * At least 2 weeks since prior radiotherapy (before vaccination) Surgery * Not specified