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Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05131711
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Combined stereotactic radiosurgery and enhanced immunotherapy
 Phase 1/Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas (inSituVac2)(CSREIG)
Actual Study Start Date :
Nov 16, 2021
Anticipated Primary Completion Date :
Nov 16, 2022
Anticipated Study Completion Date :
Nov 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy

Patients with rGBMs will receive combined stereotactic radiosurgery and enhanced immunal adjuvants (GM-CSF, Sapylin, MnCl2). The safety and efficacy will be analyzed.

Combination Product: Combined stereotactic radiosurgery and enhanced immunotherapy
Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.
Other Names:
  • stereotactic radiosurgery and GM-CSF, Sapylin, MnCl2

    		•
    No Intervention: rGBM Group with

    After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-related Adverse Events [2 years]

      Adverse events during and after the combined treatment

    2. Progression-free Survival [2 years]

      Disease progression free survival time after combined treatment

    Secondary Outcome Measures

    1. overall survival [2 years]

      Overall survival time after the combined treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Histopathologically confirmed rGBM
      1. Age18-65
      1. Participants had undergone maximal surgical resection
      1. Amount of dexamethasone was not more than 2mg/ days
      1. Ability and willingness to sign informed consent
      1. Karnofsky Performance Score of 70 or more
      1. Normal liver and kidney function
      1. Not accepted other treatment plan during the immunotherapy
    Exclusion Criteria:
      1. Not conforming to the standard
      1. 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
      1. Received other drugs for glioma therapy 60 days before participated
      1. Allergy to immune adjuvant
      1. Nervous system disease and diffuse leptomeningeal disease
      1. Amount of dexamethasone was more than 2mg/days during the immunotherapy
      1. Pregnant or lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tiantan Hospital Beijing Beijing China 100050

    Sponsors and Collaborators

    • Beijing Tiantan Hospital

    Investigators

    • Principal Investigator: Song Lin, M.D., Beijing Tiantan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Song Lin, Neurosurgery, Beijing Tiantan Hospital
    ClinicalTrials.gov Identifier:
    NCT05131711
    Other Study ID Numbers:
    • B0012
    First Posted:
    Nov 23, 2021
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Song Lin, Neurosurgery, Beijing Tiantan Hospital
    recurrent glioblastomas
    stereotactic radiosurgery
    enhanced immunotherapy
    Additional relevant MeSH terms:
    Glioblastoma
    Recurrence

    Study Results

    No Results Posted as of Nov 23, 2021