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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650257
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : March 12, 2020
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Shenzhen Second People's Hospital
Information provided by (Responsible Party):
Cure&Sure Biotech Co., LTD

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

Condition or disease Intervention/treatment Phase
Glioma of Brain Biological: gp96 Drug: Temozolomide Radiation: radiotherapy Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : August 20, 2021
Estimated Study Completion Date : August 20, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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)

Biological: gp96
25 mcg IH
Other Names:
  • Heat Shock
  • HSPPC-96

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 ).
Other Name: TZM

Radiation: radiotherapy
Stupp regimen of radiotherapy

Active Comparator: control group
Patients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered.
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 ).
Other Name: TZM

Radiation: radiotherapy
Stupp regimen of radiotherapy




Primary Outcome Measures :
  1. 1-year survival rate [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. Progression-free survival rate [ Time Frame: 1 year ]
  2. Progression-free survival [ Time Frame: 5 years ]
  3. Overall survival [ Time Frame: 5 years ]
  4. changes in antigen specific T cells [ Time Frame: within 3 days before the first vaccination and within 10 days after the last vaccination ]
    tumor antigen specific T cells are determined by IFN-γ Enzyme-linked Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.

  5. Number of participants with adverse events related to gp96 immunotherapy [ Time Frame: up to 3 months after vaccine completion ]
    A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650257


Contacts
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Contact: zhixian Gao, Doctor 086-13810876745 zhixian_g@hotmail.com

Locations
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China, Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: hua Gao    18600678822    gh2004518@163.com   
Sponsors and Collaborators
Cure&Sure Biotech Co., LTD
Beijing Tiantan Hospital
Shenzhen Second People's Hospital
Investigators
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Principal Investigator: zhixian Gao, Doctor Beijing Tiantan Hospital
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Responsible Party: Cure&Sure Biotech Co., LTD
ClinicalTrials.gov Identifier: NCT03650257    
Other Study ID Numbers: CS-TT-G-02
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Cure&Sure Biotech Co., LTD:
supratentorial glioma
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents