A Triple-blind Randomized Clinical Study of Vaccination With Dendritic Cells Loaded With Glioma Stem-like Cells Associated Antigens Against Brain Glioblastoma Multiform
Despite the advances in diagnosis and treatment (surgery +radiation +chemotherapy), median
survival for patients with newly diagnosed brain glioblastoma multiform (GBM) is about one
year, for recurrent GBM is about 4 months. Recently, immunotherapy has emerged as a novel
treatment strategy for glioma with improving patient survival. Usually, processed tumor
antigens from the patient's own tumor or a peptide vaccine is capable of producing an
anti-glioma response. Our previous experiment revealed that the CD133+ tumor stem-like cells
associated antigens could elicit highly intensive immune response against human malignant
glioma , and in phase I study, we have confirmed that DC vaccine loaded with glioma
stem-like cells associated antigens against malignant glioma in recurrent patients was of
Autologous DCs will be obtained from peripheral blood mononuclear cells (PBMCs) from each
patient. Stem-like cells associated antigens (SAA) will be prepared with glioma stem-like
cells that are harvested from patients with GBM and primary cultured and sorted
flowcytometrically and then irradiated. Approximately 4 weeks will be required for vaccine
production and the first vaccine administration. Each patient will receive an injection of
DCs at his/her assigned dose once every week during the first 6 week. The dose of DCs is
defined as 8~10×10^6.
Clinical trials that utilize DCs for immunotherapy have demonstrated significant survival
benefit for patients who exhibit robust immune responses against tumor cells. Unfortunately,
at the present time the majority of clinical trials were in phase I that illustrated the
safety. The efficacy of DCs against glioblastoma is still lack of sufficient randomized
phase II study. According to our previous phase I study, here we designed this clinical
trial in a triple-blind randomized manner to validate the efficacy of DCs vaccination.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To determine time to death in the enrolled patients.
within 2 years after the surgery
Liangfu Zhou, M.D.
Huashan Hospital, Fudan University
China: Food and Drug Administration