Glioma of Brain
Conditions
Keywords
supratentorial glioma
Brief summary
This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
Detailed description
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.
Interventions
BIOLOGICALgp96
25 mcg IH
DRUGTemozolomide
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 ).
RADIATIONradiotherapy
Stupp regimen of radiotherapy
Sponsors
Beijing Tiantan Hospital
Shenzhen Second People's Hospital
Cure&Sure Biotech Co., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able to read and understand the informed consent document; must sign the informed consent; 2. Aged 18 to 75 years old , sex is not limited; 3. Newly Diagnosed supratentoria glioma, Must have undergone a at least a 80% resection; 4. Availability of at least 4 g tumor sample; 5. Patient must receive concurrent chemoradiotherapy (temozolomide chemotherapy and radiotherapy). 6. Karnofsky functional status rating \> or equal to 70. 7. Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; Hemoglobin \> 10g/dL ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\] \<2.5 times institutional upper limit of normals \[IULNs\] ), and adequate renal function (BUN and creatinine \<1.5 times IULNs) 8. Agree to Surgical indications of Heart & lung and without the coagulation system disease 9. Except for surgery and radiotherapy and chemotherapy before vaccine treatment, no other cancer treatment is received.
Exclusion criteria
1. Inability to comply with study-related procedures 2. Unavailability of at least 6 doses of vaccine 3. Severe allergies 4. Unstable or severe intercurrent medical conditions 5. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection. 6. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids. 7. any other clinical trials within 30 days pre-vaccination. 8. Female patients who are pregnant or breastfeeding 9. Carmustine extended release implant surgery within 6 months 10. Steroidal drugs are currently being used systemically.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate | 1 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival rate | 1 year | — |
| Progression-free survival | 5 years | — |
| Overall survival | 5 years | — |
| changes in antigen specific T cells | within 3 days before the first vaccination and within 10 days after the last vaccination | 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. |
| Number of participants with adverse events related to gp96 immunotherapy | up to 3 months after vaccine completion | 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. |
Countries
China
Contacts
Primary Contactzhixian Gao, Doctor
Outcome results
None listed