Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)

Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Glioblastoma; Glioma of Brainstem; High Grade Glioma; Glioma, Malignant

Treatments: Combination Product: Combined immune adjuvants and radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03392545

B0011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Combined immune adjuvants and radiation

Experimental group

Description:

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

Treatment:

Combination Product: Combined immune adjuvants and radiation