Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

Study Overview
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Brief Summary
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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.

Official Title
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Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

Conditions
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Glioma

Intervention / Treatment
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* Biological: gp96


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read and understand the informed consent document; must sign the informed consent. Aged 18 to 75 years old , sex is not limited Newly Diagnosed supratentoria glioma, Must have undergone a at least a 80% resection Availability of at least 1 g tumor sample. Karnofsky functional status rating > or equal to 70. 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) Agree to Surgical indications of Heart & lung and without the coagulation system disease Negative pregnancy test for female patients of childbearing potential 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: Inability to comply with study-related procedures patient not suitable for Neurosurgery. Unavailability of at least 6 doses of vaccine Progression prior to vaccination as determined by the Principal Investigator Patient with allergic constitution Unstable or severe intercurrent medical conditions Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids. any other clinical trials within 30 days pre-vaccination. Female patients who are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gp96 group<br>autologous gp96 vaccination + basal treatment | Biological: gp96<br>* vaccination of autologous gp96 derived from tumor tissue + basal treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood count | blood count within 3 days before first vaccination | baseline | 
| blood count | blood count within 3 days after the second injection | within 3 days after the second injection | 
| blood count | blood count within 3 days after the 6th injection | within 3 days after the 6th injection | 
| blood chemistries | blood chemistries test within 3 days before first vaccination | baseline | 
| blood chemistries | blood chemistries test within 3 days after the second injection | within 3 days after the second injection | 
| blood chemistries | blood chemistries test within 3 days after the 6th injection | within 3 days after the 6th injection | 
| electrocardiogram | electrocardiogram test within 3 days before first vaccination | baseline | 
| electrocardiogram | electrocardiogram test within 3 days after the second injection | within 3 days after the second injection | 
| electrocardiogram | electrocardiogram test within 3 days after the 6th injection | within 3 days after the 6th injection | 
| progression-free survival rate of six month | progression-free survival rate of six month | six month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor control rate | tumor control rate at 6th month after surgery | six month after surgery | 
| progress free survive |  | up to 3 years | 
| overall survive |  | up to 3 years | 
| quality of life |  | 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. | baseline and within 3 days before the 6th injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supratentoria glioma