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Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03392545
Collaborator
Duke University (Other)
30
Enrollment
1
Location
1
Arm
26
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. 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 malignant gliomas, prolonging survivals of patients.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Combined immune adjuvants and radiation
 Phase 1

Detailed Description

High grade gliomas, such as glioblatoma (GBM) is an aggressive malignancy with a poor prognosis. The current strategy for newly diagnosed GBM patients includes surgery, chemotherapy and radiotherapy. Unfortunately, after the standard treatmetn,the median survival of GBM is only about one year. Once relapsed, 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 high grade gliomas, especially after progression, have yet to be established. Newly diagnosed GBM patients experience recurrence in five or seven months after standard treatment. We will investigate whether combining radiotherapy with intratumoral and systemic administration of immune adjuvants will improve the treatment outcome of high grade gliomas. We will use several immune adjuvants that activate innate and adaptive immunity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combined immune adjuvants and radiation

Patients with malignant gliomas will receive combined immune adjuvants (GM-CSF, TLR ligands) and radiation. The safety and efficacy will be analyzed.

Combination Product: Combined immune adjuvants and radiation
24 hours before the radiation, patients will be administrated poly I:C or CAR-T or TCR-T intratumorally and receive granulocyte macrophage colony stimulating factor 5 days after the radiation.
Other Names:
  • GM-CSF, poly I:C and radiation
  • CAR-T
  • TCR-T

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Adverse events during and after the combined treatment

    Secondary Outcome Measures

    1. Progression-free Survival [2 years]

      Disease progression free survival time after combined treatment

    2. 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 glioma

    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 60days 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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Beijing Tiantan Hospital
    • Duke University

    Investigators

    • Study Director: Peijuan Ren, M.D., Beijing Tiantan Hospital
    • Principal Investigator: Song Lin, M.D., Beijing Tiantan Hospital
    • Principal Investigator: You-Wen He, M.D. Ph.D., Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Song Lin, MD and Chief Physician, Beijing Tiantan Hospital
    ClinicalTrials.gov Identifier:
    NCT03392545
    Other Study ID Numbers:
    • B0011
    First Posted:
    Jan 8, 2018
    Last Update Posted:
    Jul 11, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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, MD and Chief Physician, Beijing Tiantan Hospital
    gliomas
    radiotherapy
    immunetherapy
    Additional relevant MeSH terms:
    Glioblastoma
    Glioma
    Adjuvants, Immunologic

    Study Results

    No Results Posted as of Jul 11, 2019