Clinical trial NCT03392545: Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
Official title: Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: High Grade Glioma
Glioblastoma
Glioma of Brainstem
Glioma, Malignant
Keywords: gliomas
radiotherapy
immunetherapy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2018-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-related Adverse Events
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Peijuan Ren, M.D.
role: STUDY_DIRECTOR
affiliation: Beijing Tiantan Hospital
name: Song Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: You-Wen He, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.