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Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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], 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02122822
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cure&Sure Biotech Co., LTD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Zhixian Gao, Doctor
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Completed
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Arms & Interventions

Arms

Experimental: gp96 group

autologous gp96 vaccination + basal treatment

Interventions

Biological: - gp96

vaccination of autologous gp96 derived from tumor tissue + basal treatment

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, China

Status

Address

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, ,

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