Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG) (CSREIG)
Primary Purpose
Recurrent Glioblastoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Combined stereotactic radiosurgery and enhanced immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring recurrent glioblastomas, stereotactic radiosurgery, enhanced immunotherapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Beijing Tiantan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy
rGBM Group with
Arm Description
Patients with rGBMs will receive combined stereotactic radiosurgery and enhanced immunal adjuvants (GM-CSF, Sapylin, MnCl2). The safety and efficacy will be analyzed.
After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group.
Outcomes
Primary Outcome Measures
Incidence of Treatment-related Adverse Events
Adverse events during and after the combined treatment
Progression-free Survival
Disease progression free survival time after combined treatment
Secondary Outcome Measures
overall survival
Overall survival time after the combined treatment
Full Information
NCT ID
NCT05131711
First Posted
November 16, 2021
Last Updated
November 16, 2021
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05131711
Brief Title
Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)
Acronym
CSREIG
Official Title
Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas (inSituVac2)(CSREIG)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
November 16, 2022 (Anticipated)
Study Completion Date
November 16, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
Keywords
recurrent glioblastomas, stereotactic radiosurgery, enhanced immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy
Arm Type
Experimental
Arm Description
Patients with rGBMs will receive combined stereotactic radiosurgery and enhanced immunal adjuvants (GM-CSF, Sapylin, MnCl2). The safety and efficacy will be analyzed.
Arm Title
rGBM Group with
Arm Type
No Intervention
Arm Description
After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group.
Intervention Type
Combination Product
Intervention Name(s)
Combined stereotactic radiosurgery and enhanced immunotherapy
Other Intervention Name(s)
stereotactic radiosurgery and GM-CSF, Sapylin, MnCl2
Intervention Description
Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.
Primary Outcome Measure Information:
Title
Incidence of Treatment-related Adverse Events
Description
Adverse events during and after the combined treatment
Time Frame
2 years
Title
Progression-free Survival
Description
Disease progression free survival time after combined treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival
Description
Overall survival time after the combined treatment
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peijuan Ren, M.D.
Phone
+861059978039
Email
ttyyirb@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Song Lin, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Lin, M.D.
Phone
861059976509
Email
linsong2005@126.com
First Name & Middle Initial & Last Name & Degree
Xiaohui Ren, M.D.
Phone
+861059976509
Email
xiaohuiren@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)
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