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

Primary Purpose

Glioma of Brain

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
gp96
Temozolomide
radiotherapy
Sponsored by
Cure&Sure Biotech Co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma of Brain focused on measuring supratentorial glioma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan Hospital Affiliated to Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gp96 group

control group

Arm Description

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)

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

Outcomes

Primary Outcome Measures

1-year survival rate

Secondary Outcome Measures

Progression-free survival rate
Progression-free survival
Overall survival
changes in antigen specific T cells
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.
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.

Full Information

First Posted
August 22, 2018
Last Updated
March 10, 2020
Sponsor
Cure&Sure Biotech Co., LTD
Collaborators
Beijing Tiantan Hospital, Shenzhen Second People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03650257
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
August 20, 2021 (Anticipated)
Study Completion Date
August 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cure&Sure Biotech Co., LTD
Collaborators
Beijing Tiantan Hospital, Shenzhen Second People's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma of Brain
Keywords
supratentorial glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gp96 group
Arm Type
Experimental
Arm Description
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)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered.
Intervention Type
Biological
Intervention Name(s)
gp96
Other Intervention Name(s)
Heat Shock, HSPPC-96
Intervention Description
25 mcg IH
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
TZM
Intervention Description
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 ).
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
Stupp regimen of radiotherapy
Primary Outcome Measure Information:
Title
1-year survival rate
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Progression-free survival rate
Time Frame
1 year
Title
Progression-free survival
Time Frame
5 years
Title
Overall survival
Time Frame
5 years
Title
changes in antigen specific T cells
Description
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.
Time Frame
within 3 days before the first vaccination and within 10 days after the last vaccination
Title
Number of participants with adverse events related to gp96 immunotherapy
Description
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.
Time Frame
up to 3 months after vaccine completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhixian Gao, Doctor
Phone
086-13810876745
Email
zhixian_g@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhixian Gao, Doctor
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hua Gao
Phone
18600678822
Email
gh2004518@163.com

12. IPD Sharing Statement

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

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