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NCT03392545 Clinical Trial

Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)

Glioblastoma Clinical Trial

— InSituVac1  

Official title:
Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03392545
Other study ID # B0011
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 1, 2018
Est. completion date June 1, 2020

Study information
Verified date July 2019
Source Beijing Tiantan Hospital
Contact Song Lin, M.D.
Phone +861067096509
Email linsong2005@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China Beijing Tiantan Hospital Beijing Beijing

Sponsors (2)
Lead Sponsor Collaborator
Beijing Tiantan Hospital Duke University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-related Adverse Events Adverse events during and after the combined treatment 2 years
Secondary Progression-free Survival Disease progression free survival time after combined treatment 2 years
Secondary Overall Survival Overall survival time after the combined treatment 2 years
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