Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-related Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histopathologically confirmed glioma
- •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
Arms & Interventions
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.
Intervention: Combined immune adjuvants and radiation (Combination Product)
Outcomes
Primary Outcomes
Incidence of Treatment-related Adverse Events
Time Frame: 2 years
Adverse events during and after the combined treatment
Secondary Outcomes
- Progression-free Survival(2 years)
- Overall Survival(2 years)
Investigators
Song Lin
MD and Chief Physician
Beijing Tiantan Hospital