Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
NCT ID: NCT02122822
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2013-07-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
gp96 group
autologous gp96 vaccination + basal treatment
gp96
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
gp96
vaccination of autologous gp96 derived from tumor tissue + basal treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Tiantan Hospital
OTHER
Cure&Sure Biotech Co., LTD
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhixian Gao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CS-TT-G-01
Identifier Type: -
Identifier Source: org_study_id