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

Glioma of Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03650257
• Other study ID #: CS-TT-G-02
• Status: Recruiting
• Phase: Phase 2
• Start date: August 21, 2019
• Est. completion date: August 20, 2024

Study information

• Verified date: February 2020
• Source: Cure&Sure Biotech Co., LTD
• Contact: zhixian Gao, Doctor
• Phone: 086-13810876745
• Email: zhixian_g[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 20, 2024
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Glioma of Brain

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Cure&Sure Biotech Co., LTD	Beijing Tiantan Hospital, Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year survival rate		1 years
Secondary	Progression-free survival rate		1 year
Secondary	Progression-free survival		5 years
Secondary	Overall survival		5 years
Secondary	changes in antigen specific T cells	tumor antigen specific T cells are determined by IFN-? Enzyme-linked Tumor antigen specific T cells will be determined by IFN-? Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.	within 3 days before the first vaccination and within 10 days after the last vaccination
Secondary	Number of participants with adverse events related to gp96 immunotherapy	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.	up to 3 months after vaccine completion