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

NCT05131711 | Unknown Phase 1

• 1 other identifier: B0012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Glioblastoma

Keywords

recurrent glioblastomas; stereotactic radiosurgery; enhanced immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• overall survival

  2 years

Study Arms (2)

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.

Combination Product: Combined stereotactic radiosurgery and enhanced immunotherapy

rGBM Group with

NO INTERVENTION

After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group.

Interventions

Combined stereotactic radiosurgery and enhanced immunotherapy COMBINATION_PRODUCT

Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.

Also known as: stereotactic radiosurgery and GM-CSF, Sapylin, MnCl2

rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histopathologically confirmed rGBM
• \. Age18-65
• \. 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

You may not qualify if:

• \. 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 60 days 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiosurgery; Granulocyte-Macrophage Colony-Stimulating Factor; streptococcal preparation 722; manganese chloride

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Song Lin, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peijuan Ren, M.D.

CONTACT

+861059978039; ttyyirb@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgery

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 23, 2021
• Study Start: November 16, 2021
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2023
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)