This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Overall Goals: \- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome. Primary Aim: \- to further evaluate effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work. Secondary Aims: to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
25 mcg IH
temozolomide monotherapy (150-200 mg / m2 / day for 5 days, then discontinuance for 23 days , 28 days for a a cycle, a total of 6 cycles ).
Stupp regimen of radiotherapy
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITING1-year survival rate
Time frame: 1 years
Progression-free survival rate
Time frame: 1 year
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
changes in antigen specific T cells
tumor antigen specific T cells are determined by IFN-γ Enzyme-linked Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.
Time frame: within 3 days before the first vaccination and within 10 days after the last vaccination
Number of participants with adverse events related to gp96 immunotherapy
A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria.
Time frame: up to 3 months after vaccine completion
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