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Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1) (InSituVac1)

Primary Purpose

High Grade Glioma, Glioblastoma, Glioma of Brainstem

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Combined immune adjuvants and radiation
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Grade Glioma focused on measuring gliomas, radiotherapy, immunetherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined immune adjuvants and radiation

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Treatment-related Adverse Events
Adverse events during and after the combined treatment

Secondary Outcome Measures

Progression-free Survival
Disease progression free survival time after combined treatment
Overall Survival
Overall survival time after the combined treatment

Full Information

First Posted
December 11, 2017
Last Updated
July 9, 2019
Sponsor
Beijing Tiantan Hospital
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03392545
Brief Title
Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
Acronym
InSituVac1
Official Title
Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Duke University

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Glioma, Glioblastoma, Glioma of Brainstem, Glioma, Malignant
Keywords
gliomas, radiotherapy, immunetherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined immune adjuvants and radiation
Arm Type
Experimental
Arm Description
Patients with malignant gliomas will receive combined immune adjuvants (GM-CSF, TLR ligands) and radiation. The safety and efficacy will be analyzed.
Intervention Type
Combination Product
Intervention Name(s)
Combined immune adjuvants and radiation
Other Intervention Name(s)
GM-CSF, poly I:C and radiation, CAR-T, TCR-T
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-related Adverse Events
Description
Adverse events during and after the combined treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Disease progression free survival time after combined treatment
Time Frame
2 years
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: Histopathologically confirmed glioma Age18-65 Participants had undergone maximal surgical resection Amount of dexamethasone was not more than 2mg/ days Ability and willingness to sign informed consent Karnofsky Performance Score of 70 or more Normal liver and kidney function Not accepted other treatment plan during the immunotherapy Exclusion Criteria: Not conforming to the standard 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 Received other drugs for glioma therapy 60days before participated Allergy to immune adjuvant Nervous system disease and diffuse leptomeningeal disease Amount of dexamethasone was more than 2mg/days during the immunotherapy Pregnant or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Song Lin, M.D.
Phone
+861067096509
Email
linsong2005@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peijuan Ren, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Song Lin, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
You-Wen He, M.D. Ph.D.
Organizational Affiliation
Duke University
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
861067096509
Email
linsong2005@126.com
First Name & Middle Initial & Last Name & Degree
Chun Zeng, M.D.
Phone
861067096509
Email
zengchun79@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34025640
Citation
Jiang H, Yu K, Cui Y, Ren X, Li M, Yang C, Zhao X, Zhu Q, Lin S. Combination of Immunotherapy and Radiotherapy for Recurrent Malignant Gliomas: Results From a Prospective Study. Front Immunol. 2021 May 7;12:632547. doi: 10.3389/fimmu.2021.632547. eCollection 2021.
Results Reference
derived

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Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)

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