Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)

NCT03392545 | Unknown Phase 1

• 1 other identifier: B0011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. 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 malignant gliomas, prolonging survivals of patients.

Conditions

High Grade Glioma; Glioblastoma; Glioma of Brainstem; Glioma, Malignant

Keywords

gliomas; radiotherapy; immunetherapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-related Adverse Events

  Adverse events during and after the combined treatment

  2 years

Secondary Outcomes (2)

• Progression-free Survival

  2 years

• Overall Survival

  2 years

Study Arms (1)

Combined immune adjuvants and radiation

EXPERIMENTAL

Patients with malignant gliomas will receive combined immune adjuvants (GM-CSF, TLR ligands) and radiation. The safety and efficacy will be analyzed.

Combination Product: Combined immune adjuvants and radiation

Interventions

Combined immune adjuvants and radiation COMBINATION_PRODUCT

24 hours before the radiation, patients will be administrated poly I:C or CAR-T or TCR-T intratumorally and receive granulocyte macrophage colony stimulating factor 5 days after the radiation.

Also known as: GM-CSF, poly I:C and radiation, CAR-T, TCR-T

Combined immune adjuvants and radiation

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 glioma
• 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 60days 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
• Duke University: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (2)

• Zheng Y, Jiang H, Yang N, Shen S, Huang D, Jia L, Ling J, Xu L, Li M, Yu K, Ren X, Cui Y, Lan X, Lin S, Lin X. Glioma-derived ANXA1 suppresses the immune response to TLR3 ligands by promoting an anti-inflammatory tumor microenvironment. Cell Mol Immunol. 2024 Jan;21(1):47-59. doi: 10.1038/s41423-023-01110-0. Epub 2023 Dec 4.

  PMID: 38049523 DERIVED

• Jiang H, Yu K, Cui Y, Ren X, Li M, Yang C, Zhao X, Zhu Q, Lin S. Combination of Immunotherapy and Radiotherapy for Recurrent Malignant Gliomas: Results From a Prospective Study. Front Immunol. 2021 May 7;12:632547. doi: 10.3389/fimmu.2021.632547. eCollection 2021.

  PMID: 34025640 DERIVED

MeSH Terms

Conditions

Glioma; Glioblastoma

Interventions

Radiation; Granulocyte-Macrophage Colony-Stimulating Factor; Poly I-C

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Phenomena; 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; Poly C; Polyribonucleotides; Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Poly I

Study Officials

• Peijuan Ren, M.D.

  Beijing Tiantan Hospital

  STUDY DIRECTOR

• Song Lin, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• You-Wen He, M.D. Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Lin, M.D.

CONTACT

+861067096509; linsong2005@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD and Chief Physician

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 8, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

CN (1)