glioblastoma
Conditions
Interventions
gp96 group:autologous gp96 vaccination + basal treatment
Sponsors
Beijing Tiantan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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] and 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. Patients with good compliance and follow-up should participate in the trial voluntarily; 9. Negative pregnancy test for female patients of childbearing potential within 7 days before study treatment; 10. 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
Exclusion criteria: 1. Inability to comply with study-related procedures; 2. patient not suitable for Neurosurgery; 3. Inavailability of at least 6 doses of vaccine; 4. Patient with allergic constitution; 5. Unstable or severe intercurrent medical conditions; 6. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection; 7. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids; 8. any other cilical trials within 30 days pre-vaccination; 9. Female patients who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety profile of gp96;progression-free survival rate of six months; | — |
Secondary
| Measure | Time frame |
|---|---|
| survivel;tumor control rate;quality of life;Immunological parameter; | — |
Countries
China
Contacts
Public ContactZhixian Gao
Outcome results
None listed