Back to resultsResearch for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Primary Purpose
Glioma
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
gp96
Sponsored by
About this trial
This is an interventional treatment trial for Glioma focused on measuring supratentoria glioma
Eligibility Criteria
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
Sites / Locations
- Beijing Tiantan Hospital Affiliated to Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gp96 group
Arm Description
autologous gp96 vaccination + basal treatment
Outcomes
Primary Outcome Measures
blood count
blood count within 3 days before first vaccination
blood count
blood count within 3 days after the second injection
blood count
blood count within 3 days after the 6th injection
blood chemistries
blood chemistries test within 3 days before first vaccination
blood chemistries
blood chemistries test within 3 days after the second injection
blood chemistries
blood chemistries test within 3 days after the 6th injection
electrocardiogram
electrocardiogram test within 3 days before first vaccination
electrocardiogram
electrocardiogram test within 3 days after the second injection
electrocardiogram
electrocardiogram test within 3 days after the 6th injection
progression-free survival rate of six month
progression-free survival rate of six month
Secondary Outcome Measures
tumor control rate
tumor control rate at 6th month after surgery
progress free survive
overall survive
quality of life
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.
Full Information
NCT ID
NCT02122822
First Posted
April 23, 2014
Last Updated
November 15, 2017
Sponsor
Cure&Sure Biotech Co., LTD
Collaborators
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02122822
Brief Title
Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Official Title
Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cure&Sure Biotech Co., LTD
Collaborators
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
supratentoria glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gp96 group
Arm Type
Experimental
Arm Description
autologous gp96 vaccination + basal treatment
Intervention Type
Biological
Intervention Name(s)
gp96
Intervention Description
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Primary Outcome Measure Information:
Title
blood count
Description
blood count within 3 days before first vaccination
Time Frame
baseline
Title
blood count
Description
blood count within 3 days after the second injection
Time Frame
within 3 days after the second injection
Title
blood count
Description
blood count within 3 days after the 6th injection
Time Frame
within 3 days after the 6th injection
Title
blood chemistries
Description
blood chemistries test within 3 days before first vaccination
Time Frame
baseline
Title
blood chemistries
Description
blood chemistries test within 3 days after the second injection
Time Frame
within 3 days after the second injection
Title
blood chemistries
Description
blood chemistries test within 3 days after the 6th injection
Time Frame
within 3 days after the 6th injection
Title
electrocardiogram
Description
electrocardiogram test within 3 days before first vaccination
Time Frame
baseline
Title
electrocardiogram
Description
electrocardiogram test within 3 days after the second injection
Time Frame
within 3 days after the second injection
Title
electrocardiogram
Description
electrocardiogram test within 3 days after the 6th injection
Time Frame
within 3 days after the 6th injection
Title
progression-free survival rate of six month
Description
progression-free survival rate of six month
Time Frame
six month after surgery
Secondary Outcome Measure Information:
Title
tumor control rate
Description
tumor control rate at 6th month after surgery
Time Frame
six month after surgery
Title
progress free survive
Time Frame
up to 3 years
Title
overall survive
Time Frame
up to 3 years
Title
quality of life
Time Frame
up to 3 years
Title
changes in antigen specific T cells
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixian Gao, Doctor
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical University
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
29769450
Citation
Ji N, Zhang Y, Liu Y, Xie J, Wang Y, Hao S, Gao Z. Heat shock protein peptide complex-96 vaccination for newly diagnosed glioblastoma: a phase I, single-arm trial. JCI Insight. 2018 May 17;3(10):e99145. doi: 10.1172/jci.insight.99145. eCollection 2018 May 17.
Results Reference
derived
Learn more about this trial
Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
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