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

NCT03650257 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: CS-TT-G-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glioma of Brain

Keywords

supratentorial glioma

Outcome Measures

Primary Outcomes (1)

• 1-year survival rate

  1 years

Secondary Outcomes (5)

• Progression-free survival rate

  1 year

• Progression-free survival

  5 years

• Overall survival

  5 years

• changes in antigen specific T cells

  within 3 days before the first vaccination and within 10 days after the last vaccination

• Number of participants with adverse events related to gp96 immunotherapy

  up to 3 months after vaccine completion

Study Arms (2)

gp96 group

EXPERIMENTAL

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; Drug: Temozolomide; Radiation: radiotherapy

control group

ACTIVE COMPARATOR

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

Drug: Temozolomide; Radiation: radiotherapy

Interventions

gp96 BIOLOGICAL

25 mcg IH

Also known as: Heat Shock, HSPPC-96

gp96 group

Temozolomide DRUG

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 ).

Also known as: TZM

control group; gp96 group

radiotherapy RADIATION

Stupp regimen of radiotherapy

control group; gp96 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and understand the informed consent document; must sign the informed consent;
• Aged 18 to 75 years old , sex is not limited;
• Newly Diagnosed supratentoria glioma, Must have undergone a at least a 80% resection;
• Availability of at least 4 g tumor sample;
• Patient must receive concurrent chemoradiotherapy (temozolomide chemotherapy and radiotherapy).
• Karnofsky functional status rating \> or equal to 70.
• 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)
• Agree to Surgical indications of Heart \& lung and without the coagulation system disease
• Except for surgery and radiotherapy and chemotherapy before vaccine treatment, no other cancer treatment is received.

You may not qualify if:

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

Sponsors & Collaborators

• Cure&Sure Biotech Co., LTD: lead
• Beijing Tiantan Hospital: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Interventions

glucose-regulated proteins; Heat-Shock Response; vitespin; Temozolomide; Radiotherapy

Intervention Hierarchy (Ancestors)

Stress, Physiological; Physiological Phenomena; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• zhixian Gao, Doctor

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhixian Gao, Doctor

CONTACT

086-13810876745; zhixian_g@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 28, 2018
• Study Start: August 21, 2019
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2024
• Last Updated: March 12, 2020

Record last verified: 2020-02

Locations

CN (1)