A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

Study Purpose

This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.

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 4 g tumor sample; 5. Patient must receive concurrent chemoradiotherapy (temozolomide chemotherapy and radiotherapy). 6. Karnofsky functional status rating > or equal to 70. 7. 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) 8. Agree to Surgical indications of Heart & lung and without the coagulation system disease. 9. Except for surgery and radiotherapy and chemotherapy before vaccine treatment, no other cancer treatment is received.

Exclusion Criteria:

1. Inability to comply with study-related procedures. 2. Unavailability of at least 6 doses of vaccine. 3. Severe allergies. 4. Unstable or severe intercurrent medical conditions. 5. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection. 6. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids. 7. any other clinical trials within 30 days pre-vaccination. 8. Female patients who are pregnant or breastfeeding. 9. Carmustine extended release implant surgery within 6 months. 10. Steroidal drugs are currently being used systemically.

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.

NCT03650257
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 2
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 Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma of Brain
Additional Details

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. Overall Goals:

  • - to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
Primary Aim:
  • - to further evaluate effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
Secondary Aims: to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.

Arms & Interventions

Arms

Experimental: gp96 group

Patients receive standard treatment with radiation and temozolomide after surgery. Then 6 times of autologous gp96 vaccination are administered via subcutaneous injection in 25μg doses at the 2nd week after the end of postoperative radiotherapy. ( gp96 is administered once a week for the first 4 weeks, the 5th injection is administered 2 weeks after the 4th injection, and the 6th injection is administered 3 weeks after the 5th injection. ) The first adjunctive temozolomide startes on the day of the fifth gp96 injection. (150-200 mg/m2/day for 5 days, then stop for 23 days, one cycle is 28 days for a total of 6 cycles)

Active Comparator: control group

Patients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered.

Interventions

Biological: - gp96

25 mcg IH

Drug: - Temozolomide

temozolomide monotherapy (150-200 mg / m2 / day for 5 days, then discontinuance for 23 days , 28 days for a a cycle, a total of 6 cycles ).

Radiation: - radiotherapy

Stupp regimen of radiotherapy

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, Beijing, China

Status

Recruiting

Address

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing, 100050

Site Contact

hua Gao

gh2004518@163.com

18600678822

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