Glioma of BrainPhase 2NCT03650257
A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
A Phase 2 study testing gp96, Temozolomide and radiotherapy in people with Glioma of Brain, run by Cure&Sure Biotech Co., LTD at 1 site in China.
Trial summary
This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma of Brain
- What is being tested?
- gp96, Temozolomide and radiotherapy
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2019to 20 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050
hua Gao, 18600678822, gh2004518@163.com
About this study
This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
Read the 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.
- Conditions
- Glioma of Brain
- Being tested
- gp96, Temozolomide, radiotherapy
- Keywords
- supratentorial glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp96Biological
Also called Heat Shock, HSPPC-96
25 mcg IH
TemozolomideDrug
Also called TZM
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 ).
radiotherapyRadiation
Stupp regimen of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Drug: Temozolomide; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year survival rate
Measured: 1 years
Secondary outcomes (5)
Progression-free survival rate
Measured: 1 year
Progression-free survival
Measured: 5 years
Overall survival
Measured: 5 years
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.
Measured: 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
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.
Measured: up to 3 months after vaccine completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start21 Aug 2019
- Primary completion20 Aug 2021 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma of BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cure&Sure Biotech Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital, Shenzhen Second People's Hospital
- Responsible party
- Sponsor
- Investigators
- zhixian Gao, Doctor, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650257
- Sponsor's protocol ID
- CS-TT-G-02
- Status last verified
- Feb 2020
- First submitted
- 22 Aug 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
- ClinicalTrials.gov ID
- NCT03650257
- Acronym / sponsor ID
- CS-TT-G-02
- Conditions
- Glioma of Brain
- Keywords
- supratentorial glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cure&Sure Biotech Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital, Shenzhen Second People's Hospital
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 20 Aug 2021 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gp96 group | Experimental | Biological: gp96, Drug: Temozolomide, Radiation: radiotherapyPatients 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) |
| control group | Active comparator | Drug: Temozolomide, Radiation: radiotherapyPatients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gp96Also: Heat Shock, HSPPC-9625 mcg IH | Biological | gp96 group |
| TemozolomideAlso: TZMtemozolomide 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 ). | Drug | control group, gp96 group |
| radiotherapyStupp regimen of radiotherapy | Radiation | control group, gp96 group |
Primary outcome
1-year survival rate
Time frame: 1 years
5 secondary outcomes
Progression-free survival rate
Time frame: 1 year
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
changes in antigen specific T cells
Time frame: 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
Time frame: up to 3 months after vaccine completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhixian Gao, Doctor principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gp96, Temozolomide and radiotherapy in people with Glioma of Brain, run by Cure&Sure Biotech Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhixian Gao, Doctor (086-13810876745, zhixian_g@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year survival rate (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.