Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma
Trial Parameters
Brief Summary
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).
Eligibility Criteria
After signing the informed consent form for pre-screening, patient will assess the procedures to obtain sufficient leukapheretic material for the dendritic cell vaccine manufacturing and will perform the standard radiochemotherapy treatment (Stupp regimen) for the disease. For the pre-screening phase of the study the eligibility criteria are: 1. Histologically confirmed "monofocal" glioblastoma 2. Near-complete resection (= 5 ml residual tumor volume) confirmed by "central neuroradiologist on magnetic resonance imaging (MRI) or CT scan within 72 h postoperative" 3. Karnofsky performance status (KPS) = 70% or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Appendix A) 4. Be willing and able to provide written informed consent/assent for the pre-screening phase of the trial. 5. Be = 18 years of age on day of signing informed consent. 6. Life expectancy of greater than 12 weeks. 7. Patient suitable for the collection of biological material