Efficacy & Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme After Complete Surgical Resection
NCT01006044
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Brief Summary
1. Primary outcome measure: a.Evaluation of the treatment impact on progression-free survival. 2. Secondary outcome measures: 1. Safety evaluation. * Direct effects attributable cell obtaining and administration. * Adverse events during treatment. * Neurological deterioration quantified using the NIH Stroke Scale. * Autoimmune phenomena. 2. Evaluation of impact on other efficiency clinical parameters. * Overall survival. * Quality of life measured with EORTC questionnaire. 3. Study of specific immune response and correlates with clinical outcome. * Delayed hypersensitivity. * Humoral response to autologous tumor cells/tumoral lysate. * Cellular response (proliferation, cytokine production, specific cytotoxicity). 4. Cell line characterization and correlate the final product with clinical efficacy. * Phenotypic studies.
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