Adjuvant dendritic-cell immunotherapy plus temozolomide following surgery and chemoradiation in patients with newly diagnosed glioblastoma

Prior treatment

• Prior radiation or chemotherapy
• Any pre-existing contraindication for temozolomide treatment

Other illness

• History of another malignancy, except for adequately controlled basal cell skin carcinoma, squamous skin carcinoma, or carcinoma in situ of the uterine cervix or unless the investigator rationalizes otherwise
• Known positive viral serology for HIV, HBV, HCV, or syphilis
• Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications

Other

• Any pre-existing contraindication for contrast-enhanced brain MRI
• Pregnant or breast-feeding
• Documented immune deficiency or systemic immune-suppressive treatment

• Newly diagnosed, histologically verified glioblastoma (WHO grade IV)
• Life expectancy ≥ 3 months as estimated by the Investigator
• Aged ≥ 18 years
• Total or subtotal resection: (A) Total resection = macroscopic complete resection as assessed by the neurosurgeon and absence of any residual contrast-enhancing mass on post-operative (≤ 72h) brain MRI (B) Subtotal resection = macroscopic complete resection as assessed by the neurosurgeon, but with residual contrast-enhancement ≤ 2 cm³ on post-operative (≤ 72h) brain MRI
• Signed informed consent
• Willing and able to comply with the protocol as judged by the Investigator
• Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection
• Fit to undergo: leukapheresis, chemoradiation, chemotherapy and immunotherapy
• No corticosteroid treatment ≤ 1 week before apheresis
• WHO performance status ≤ 2