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. PURPOSE: This trial is studying the safety and effectiveness of autologous gp96 treatment of glioblastoma and to see how well it works in treating patients with newly diagnosed supratentoria glioma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, China
blood count
blood count within 3 days before first vaccination
Time frame: baseline
blood count
blood count within 3 days after the second injection
Time frame: within 3 days after the second injection
blood count
blood count within 3 days after the 6th injection
Time frame: within 3 days after the 6th injection
blood chemistries
blood chemistries test within 3 days before first vaccination
Time frame: baseline
blood chemistries
blood chemistries test within 3 days after the second injection
Time frame: within 3 days after the second injection
blood chemistries
blood chemistries test within 3 days after the 6th injection
Time frame: within 3 days after the 6th injection
electrocardiogram
electrocardiogram test within 3 days before first vaccination
Time frame: baseline
electrocardiogram
electrocardiogram test within 3 days after the second injection
Time frame: within 3 days after the second injection
electrocardiogram
electrocardiogram test within 3 days after the 6th injection
Time frame: within 3 days after the 6th injection
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progression-free survival rate of six month
progression-free survival rate of six month
Time frame: six month after surgery
tumor control rate
tumor control rate at 6th month after surgery
Time frame: six month after surgery
progress free survive
Time frame: up to 3 years
overall survive
Time frame: up to 3 years
quality of life
Time frame: up to 3 years
changes in antigen specific T cells
tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.
Time frame: baseline and within 3 days before the 6th injection