Safe Study of Dendritic Cell (DC) Based Therapy Targeting Tumor Stem Cells in Glioblastoma

Inclusion criteria

• Accessible volume and quality of tumor tissue for vaccine production
• MRI after surgery with minimal tumor remnant.
• Between 18 and 70 years of age.
• Must have histologically confirmed glioma grade IV, and a candidate for combined radiation therapy and chemotherapy ("Stupps regimen").
• Must be ambulatory with a ECOG performance status 0 or 1.
• A minimum 4 weeks must have elapsed between the end of glucocorticoid treatment and beginning of vaccination.
• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented.

Exclusion criteria

• Tumor in a localization where a modest increase in size due to reactive oedema may have a large impact on patients neurological condition.
• Large tumor remnant after surgery.
• History of prior malignancy other than glioma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB.
• Chronic active infection requiring antibiotic therapy.
• Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
• Prior splenectomy.
• Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure.
• Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
• History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis- dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
• Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
• Pregnancy or lactation.
• Any reason why, in the opinion of the investigator, the patient should not participate.