Recurrent GlioblastomaPhase 1/2CSREIGNCT05131711
Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)
A Phase 1/2 study testing Combined stereotactic radiosurgery and enhanced immunotherapy in people with Recurrent Glioblastoma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The study will investigate combined stereotactic radiosurgery and enhanced immunotherapy for recurrent glioblastomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Combined stereotactic radiosurgery and enhanced immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2021to 16 Nov 2023
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histopathologically confirmed rGBM
- 2. Age18-65
- 3. Participants had undergone maximal surgical resection
- 4. Amount of dexamethasone was not more than 2mg/ days
- 5. Ability and willingness to sign informed consent
- 6. Karnofsky Performance Score of 70 or more
- 7. Normal liver and kidney function
- 8. Not accepted other treatment plan during the immunotherapy
Who cannot join
- 1. Not conforming to the standard
- 2. Systemic illness or medical condition may pose additional risk,including cardiac, incompensated renal or liver function abnormalities;inflammatory and immune system diseases of rheumatic arthritis
- 3. Received other drugs for glioma therapy 60 days before participated
- 4. Allergy to immune adjuvant
- 5. Nervous system disease and diffuse leptomeningeal disease
- 6. Amount of dexamethasone was more than 2mg/days during the immunotherapy
- 7. Pregnant or lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Song Lin, M.D., 861059976509, linsong2005@126.com
Xiaohui Ren, M.D., +861059976509, xiaohuiren@aliyun.com
About this study
Official title: Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas (inSituVac2)(CSREIG)
The study will investigate combined stereotactic radiosurgery and enhanced immunotherapy for recurrent glioblastomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the specific antitumor immunity in patients with recurrent glioblastomas, prolonging survivals of patients.
Read the detailed description
Recurrent glioblatoma (rGBM) is an aggressive malignancy with a poor prognosis. There is no standard therapy and survival is less than 9 months. Recently, personalized cancer immunotherapy has shown great promise in treating different types of cancers. However, effective immunotherapies for rGBMs have yet to be established. The last clinical trial (inSituVac1) showed promised results and this study was based on it. We will investigate whether combining stereotactic radiosurgery with intratumoral and systemic administration of enhanced immune adjuvants will improve the treatment outcome of rGBMs. We will use several immune adjuvants that activate innate and adaptive immunity.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Combined stereotactic radiosurgery and enhanced immunotherapy
- Keywords
- recurrent glioblastomas, stereotactic radiosurgery, enhanced immunotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined stereotactic radiosurgery and enhanced immunotherapyCombination product
Also called stereotactic radiosurgery and GM-CSF, Sapylin, MnCl2
Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.
| Study group | Role | What they receive |
|---|---|---|
| rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy | Experimental | Patients with rGBMs will receive combined stereotactic radiosurgery and enhanced immunal adjuvants (GM-CSF, Sapylin, MnCl2). The safety and efficacy will be analyzed. Receives: Combination Product: Combined stereotactic radiosurgery and enhanced immunotherapy |
| rGBM Group with | No intervention | After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-related Adverse Events
Adverse events during and after the combined treatment
Measured: 2 years
Progression-free Survival
Disease progression free survival time after combined treatment
Measured: 2 years
Secondary outcomes (1)
overall survival
Overall survival time after the combined treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start16 Nov 2021
- Primary completion16 Nov 2022 (estimated)
- Study completion16 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Lin, Beijing Tiantan Hospital
- Investigators
- Song Lin, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131711
- Sponsor's protocol ID
- B0012
- Acronym
- CSREIG
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas (inSituVac2)(CSREIG)
- ClinicalTrials.gov ID
- NCT05131711
- Acronym / sponsor ID
- CSREIG / B0012
- Conditions
- Recurrent Glioblastoma
- Keywords
- recurrent glioblastomas, stereotactic radiosurgery, enhanced immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 16 Nov 2022 (estimated)
- Study completion
- 16 Nov 2023 (estimated)
- First posted
- 23 Nov 2021 (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.
The study will investigate combined stereotactic radiosurgery and enhanced immunotherapy for recurrent glioblastomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the specific antitumor immunity in patients with recurrent glioblastomas, prolonging survivals of patients.
Detailed description
Recurrent glioblatoma (rGBM) is an aggressive malignancy with a poor prognosis. There is no standard therapy and survival is less than 9 months. Recently, personalized cancer immunotherapy has shown great promise in treating different types of cancers. However, effective immunotherapies for rGBMs have yet to be established. The last clinical trial (inSituVac1) showed promised results and this study was based on it. We will investigate whether combining stereotactic radiosurgery with intratumoral and systemic administration of enhanced immune adjuvants will improve the treatment outcome of rGBMs. We will use several immune adjuvants that activate innate and adaptive immunity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy | Experimental | Combination Product: Combined stereotactic radiosurgery and enhanced immunotherapyPatients with rGBMs will receive combined stereotactic radiosurgery and enhanced immunal adjuvants (GM-CSF, Sapylin, MnCl2). The safety and efficacy will be analyzed. |
| rGBM Group with | No intervention | –After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Histopathologically confirmed rGBM
- 2. Age18-65
- 3. Participants had undergone maximal surgical resection
- 4. Amount of dexamethasone was not more than 2mg/ days
- 5. Ability and willingness to sign informed consent
Key exclusion criteria (7 listed)
- 1. Not conforming to the standard
- 2. Systemic illness or medical condition may pose additional risk,including cardiac, incompensated renal or liver function abnormalities;inflammatory and immune system diseases of rheumatic arthritis
- 3. Received other drugs for glioma therapy 60 days before participated
- 4. Allergy to immune adjuvant
- 5. Nervous system disease and diffuse leptomeningeal disease
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 |
|---|---|---|
| Combined stereotactic radiosurgery and enhanced immunotherapyAlso: stereotactic radiosurgery and GM-CSF, Sapylin, MnCl2Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery. | Combination product | rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy |
Primary outcome
Incidence of Treatment-related Adverse Events
Time frame: 2 years
Adverse events during and after the combined treatment
Progression-free Survival
Time frame: 2 years
Disease progression free survival time after combined treatment
1 secondary outcome
overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Recurrent Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
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.
Song Lin, M.D. 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 1/2 study testing Combined stereotactic radiosurgery and enhanced immunotherapy in people with Recurrent Glioblastoma, run by Beijing Tiantan Hospital 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 8 inclusion and 7 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 23 Nov 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Peijuan Ren, M.D. (+861059978039, ttyyirb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-related Adverse Events (time frame: 2 years). The study lists 2 primary outcomes in all. 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 23 Nov 2021.