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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy | Experimental | Patients with rGBMs will receive combined stereotactic radiosurgery and enhanced immunal adjuvants (GM-CSF, Sapylin, MnCl2). The safety and efficacy will be analyzed. |
|
| rGBM Group with | No Intervention | After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined stereotactic radiosurgery and enhanced immunotherapy | Combination Product | Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-related Adverse Events | Adverse events during and after the combined treatment | 2 years |
| Progression-free Survival | Disease progression free survival time after combined treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Overall survival time after the combined treatment | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peijuan Ren, M.D. | Contact | +861059978039 | ttyyirb@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Song Lin, M.D. | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C569879 | streptococcal preparation 722 |
| C025340 | manganese chloride |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |