Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)

Recurrent Glioblastoma Clinical Trial

— CSREIG  

Official title:

Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas (inSituVac2)(CSREIG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05131711
• Other study ID #: B0012
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 16, 2021
• Est. completion date: November 16, 2023

Study information

• Verified date: November 2021
• Source: Beijing Tiantan Hospital
• Contact: Peijuan Ren, M.D.
• Phone: +861059978039
• Email: ttyyirb[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma

Intervention

Combination Product:
• Combined stereotactic radiosurgery and enhanced immunotherapy
Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-related Adverse Events	Adverse events during and after the combined treatment	2 years
Primary	Progression-free Survival	Disease progression free survival time after combined treatment	2 years
Secondary	overall survival	Overall survival time after the combined treatment	2 years