Clinical trial NCT03650257: A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Official title: A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioma of Brain
Keywords: supratentorial glioma
Lead sponsor: Cure&Sure Biotech Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
name: Shenzhen Second People's Hospital
First posted: 2018-08-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: 1-year survival rate
timeFrame: 1 years
Secondary outcomes:
measure: Progression-free survival rate
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: changes in antigen specific T cells
timeFrame: within 3 days before the first vaccination and within 10 days after the last vaccination
measure: Number of participants with adverse events related to gp96 immunotherapy
timeFrame: up to 3 months after vaccine completion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: zhixian Gao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: