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

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.

Timeline

Start

2009-10

Primary completion

2014-08

Completion

2014-08

Publications

• Background Liau LM, Black KL, Prins RM, Sykes SN, DiPatre PL, Cloughesy TF, Becker DP, Bronstein JM. Treatment of intracranial gliomas with bone marrow-derived dendritic cells pulsed with tumor antigens. J Neurosurg. 1999 Jun;90(6):1115-24. doi: 10.3171/jns.1999.90.6.1115.
• Background Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
• Background Omuro AM, Faivre S, Raymond E. Lessons learned in the development of targeted therapy for malignant gliomas. Mol Cancer Ther. 2007 Jul;6(7):1909-19. doi: 10.1158/1535-7163.MCT-07-0047.
• Inoges S, Tejada S, de Cerio AL, Gallego Perez-Larraya J, Espinos J, Idoate MA, Dominguez PD, de Eulate RG, Aristu J, Bendandi M, Pastor F, Alonso M, Andreu E, Cardoso FP, Valle RD. A phase II trial of autologous dendritic cell vaccination and radiochemotherapy following fluorescence-guided surgery in newly diagnosed glioblastoma patients. J Transl Med. 2017 May 12;15(1):104. doi: 10.1186/s12967-017-1202-z.

Drugs

Indications