Single arm, monocentric trial to assess the safety and the progression-free survival related to the combined treatment of dendritic cell vaccine loaded with autologous tumor homogenate and temozolomide in patients operated for glioblastoma and then treated with standard radiochemotherapy (according to Stupp regimen).
Histologically confirmed "monofocal" glioblastoma
Near-complete resection (= 5 ml residual tumor volume) confirmed by "central neuroradiologist on magnetic resonance imaging (MRI) or CT scan within 72 h postoperative"
Karnofsky performance status (KPS) = 70% or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Appendix A)
Be willing and able to provide written informed consent/assent for the pre-screening phase of the trial.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy > 10 mg prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has a known history of active Bacillus Tuberculosis (TB)
Previous treatment with a cancer vaccine
Single group
Autologous Dendritic Cells (DC) vaccine
Biological/Vaccine10×10exp6 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)
Temozolomide
DrugAdjuvant temozolomide assumed orally from day 1 to 5 (start on week 5). Dosage: 150mg/m2/day for the first cycle and 200 mg/m2/day for subsequent cycles (q28).
clinical activity
Progression free survival (PFS), measured as the proportion of patients without progression of disease at three months from leukapheresis
Incidence of Treatment-Emergent Adverse Events
Proportion of patients experienced grade 3 or higher adverse events related to the study treatment
Immune response in vivo
Evaluation of the prognostic role of a positive DTH test after at least four vaccine administrations
Clinical Outcome (Overall Survival (OS))
Overall Survival (OS) is calculated as the time from the date of leukapheresis to the date of death for any cause. Patients still alive at the time of analysis are censored at the last time they are known to be alive.
Immunological efficacy
Immunological efficacy: ability to enhance the proportion of circulating immune effectors specific for tumor antigens; evaluation of the persistence of an anti-tumor immune response; determination of plasma levels of a panel of inflammatory cytokines and pro-angiogenic factors; evaluation of the prognostic and predictive role of tumor antigen expression in tumor tissue; analysis of the prognostic and predictive role of immune cells in the peripheral blood and in the tumor microenvironment
Human leukocyte antigen (HLA) class I and II characterization characterization of patients
Explorative endpoint (optional participation for patients): HLA class I and II characterization of patients
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