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Efficacy & Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme After Complete Surgical Resection

NCT01006044

PHASE2INTERVENTIONAL
Clinica Universidad de Navarra, Universidad de Navarra
26 participants
Started 2009-10 · Completed 2014-08
Status: Completed (as of 12-23-2025)

Conditions

Glioblastoma Multiforme

Linked Papers (from SciSciNet-V2)

Total Papers3
Background
0
Result
0
Derived
0
Unknown
3

Total Citations Per Year

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.