Phase I/II Trial of Vaccine Therapy With Tumor Stem Cell Derived mRNA- Transfected Dendritic Cells in Patients Receiving Standard Therapy for Glioblastoma
- 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.
- 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
- 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