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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Glioblastoma
• Intervention / Treatment: Combination product: Combined stereotactic radiosurgery and enhanced immunotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Peijuan Ren, M.D.; Phone Number: +861059978039; Email: ttyyirb@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Song Lin, M.D.; Phone Number: 861059976509; Email: linsong2005@126.com
      • Contact: Xiaohui Ren, M.D.; Phone Number: +861059976509; Email: xiaohuiren@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy; Patients with rGBMs will receive combined stereotactic radiosurgery and enhanced immunal adjuvants (GM-CSF, Sapylin, MnCl2). The safety and efficacy will be analyzed.	Combination product: Combined stereotactic radiosurgery and enhanced immunotherapy; Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.; Other Names: stereotactic radiosurgery and GM-CSF, Sapylin, MnCl2
No Intervention: rGBM Group with; After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	Overall survival time after the combined treatment	2 years

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Song Lin, M.D., Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Anticipated): November 16, 2022
• Study Completion (Anticipated): November 16, 2023

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: stereotactic radiosurgery; recurrent glioblastomas; enhanced immunotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Recurrence
• Other Study ID Numbers: B0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No