Recurrent Glioblastoma
Conditions
Keywords
recurrent glioblastomas, stereotactic radiosurgery, enhanced immunotherapy
Brief summary
The study will investigate combined stereotactic radiosurgery and enhanced immunotherapy for recurrent glioblastomas. 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 recurrent glioblastomas, prolonging survivals of patients.
Detailed description
Recurrent glioblatoma (rGBM) is an aggressive malignancy with a poor prognosis. 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 rGBMs have yet to be established. The last clinical trial (inSituVac1) showed promised results and this study was based on it. We will investigate whether combining stereotactic radiosurgery with intratumoral and systemic administration of enhanced immune adjuvants will improve the treatment outcome of rGBMs. We will use several immune adjuvants that activate innate and adaptive immunity.
Interventions
COMBINATION_PRODUCTCombined stereotactic radiosurgery and enhanced immunotherapy
Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Histopathologically confirmed rGBM * 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 60 days 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-related Adverse Events | 2 years | Adverse events during and after the combined treatment |
| Progression-free Survival | 2 years | Disease progression free survival time after combined treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 2 years | Overall survival time after the combined treatment |
Countries
China
Contacts
Primary ContactPeijuan Ren, M.D.
Outcome results
None listed