Glioma
Conditions
Keywords
supratentoria glioma
Brief summary
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.
Interventions
BIOLOGICALgp96
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Sponsors
Beijing Tiantan Hospital
Cure&Sure Biotech Co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 1 g tumor sample. 5. Karnofsky functional status rating \> or equal to 70. 6. 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) 7. Agree to Surgical indications of Heart & lung and without the coagulation system disease 8. Negative pregnancy test for female patients of childbearing potential 9. Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration
Exclusion criteria
1. Inability to comply with study-related procedures 2. patient not suitable for Neurosurgery. 3. Unavailability of at least 6 doses of vaccine 4. Progression prior to vaccination as determined by the Principal Investigator 5. Patient with allergic constitution 6. Unstable or severe intercurrent medical conditions 7. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection. 8. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids. 9. any other clinical trials within 30 days pre-vaccination. 10. Female patients who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| electrocardiogram | baseline | electrocardiogram test within 3 days before first vaccination |
| progression-free survival rate of six month | six month after surgery | progression-free survival rate of six month |
| blood count | baseline | blood count within 3 days before first vaccination |
| blood chemistries | baseline | blood chemistries test within 3 days before first vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tumor control rate | six month after surgery | tumor control rate at 6th month after surgery |
| changes in antigen specific T cells | baseline and within 3 days before the 6th injection | tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen. |
| progress free survive | up to 3 years | — |
| overall survive | up to 3 years | — |
| quality of life | up to 3 years | — |
Countries
China
Outcome results
None listed