Function and Composition of Regulatory B Cells in Participants With Glioblastoma

Glioblastoma, Adult Clinical Trial

— GBMdexaB  

Official title:

The Function and Composition of B Cells in Participants With Glioblastoma Treated With and Without Dexamethasone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128774
• Other study ID #: 2019.554
• Secondary ID: CCA2018-5-50NL71
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2021
• Source: VU University Medical Center
• Contact: Mathilde CM Kouwenhoven, MD, PhD
• Phone: +31 20 4444444
• Email: m.kouwenhoven[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rationale: This project elaborates on a novel finding of the investigators that has not yet been reported in literature, namely the presence of elevated levels of atypical B cells in participants with glioblastoma. ln the period 2015 2018 the investigators analysed the blood immune subset composition of a cohort of 180 participants undergoing neurosurgery. The most relevant finding was the presence of an abnormally elevated level of B cells in the blood of the great majority of participants with glioblastoma. These B cells may be involved in the immunosuppression associated with glioblastoma that makes this tumor refractory to immunotherapy. Multiple regression analysis indicated that the increase in the frequency of atypical B cells in participants' peripheral blood was related with the administration of dexamethasone prior to surgery. However, this study design did not allow the investigators to address the causality of the relationship between dexamethasone and atypic B cell dysregulation. Alternative treatments to dexamethasone exist.

Objective: To investigate the effect of dexamethasone in the dysregulation of atypic B cells in participants with glioblastoma.

Study design: Observational case control pilot study with 20 participants (10 per group).

Study population: Newly diagnosed participants with glioblastoma. Intervention (if applicable): Observational study. Main study parameters/endpoints: Changes in the immune subset composition and functionality in the peripheral blood of participants with glioblastoma upon administration of dexamethasone for neurological signs of peritumoral edema (oral dexamethasone).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators will collect blood (28 ml) during the first visit and again (28 ml) at the time of surgery (2 weeks ± 3 days). There will not be additional site visits, physical examinations or any other tests, questionnaires. Blood collection is only a minor discomfort and it does not represent any additional risk.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Clinical diagnosis Glioblastoma Patients are 18 years or older at first diagnosis

Exclusion Criteria:

No indication for surgery to confirm radiological diagnosis Not able or willing to give informed consent Allergy or intolerance to dexamethasone

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma, Adult

Intervention

Drug:
• Dexamethasone
The case group receives dexamethasone based on the clinical indication.

Locations

Country	Name	City	State
Netherlands	Amsterdam Medical Universities	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Dusoswa SA, Verhoeff J, Garcia-Vallejo JJ. OMIP-054: Broad Immune Phenotyping of Innate and Adaptive Leukocytes in the Brain, Spleen, and Bone Marrow of an Orthotopic Murine Glioblastoma Model by Mass Cytometry. Cytometry A. 2019 Apr;95(4):422-426. doi: 10.1002/cyto.a.23725. Epub 2019 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of regulatory B cells in blood of participant with Glioblastoma	ldentify if dexamethasone treatment alters the frequency and functionality of atypic B cells (CD25+CD95Fas+-B cells) in blood in GBM.	Two weeks
Secondary	Changes in frequency of regulatory B cells after treatment of participants with Glioblastoma with dexamethasone	Changes in the frequency and functionality of regulatory B cells in blood after two weeks of treatment with dexamethasone.	Two weeks
Secondary	Changes in frequency of regulatory B cells in participants with Glioblastoma	Changes in the frequency and functionality of regulatory B cells in blood in patients not treated with dexamethasone.	Two weeks