Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma: a Phase II Study
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
• THE AUTOLOGOUS SURGICAL SPECIMEN NEEDED FOR VACCINE MANUFACTURING MUST HAVE BEEN COLLECTED AND SENT TO THE SOMATIC CELL THERAPY LAB OF ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) ISTITUTO DI RICOVERO E CURA A CARATTERE SCIENTIFICO (IRCCS) AND MUST FULFIL ALL THE ACCEPTANCE CRITERIA PRESCRIBED BY THE GOOD MANUFACTURING PRACTICES (GMP) PROCEDURES.
• Availability of sufficient leukapheretic material for the preparation of the vaccine product.
• No progressive disease near-complete resection (= 5 ml residual tumor volume) confirmed by MRI after standard radiochemotherapy treatment (Stupp regimen)
• Patients must have recovered (grade 1 or less by CTCAE 5.0) from all the events related to previous treatments.
• Be willing and able to provide written informed consent/assent for the trial.
• Be \>= 18 years of age on day of signing informed consent.
• Have a Karnofsky performance status (KPS) = 70% or a performance status of 0 or 1 on the ECOG Performance Scale.
• Demonstrate adequate organ and marrow function