Function and Composition of Regulatory B Cells in Participants With Glioblastoma (GBMdexaB)

Amsterdam UMC, location VUmc

Status: Terminated

Conditions: Glioblastoma, Adult

Treatments: Drug: Dexamethasone

Study type: Observational

Funder types: Other

Identifiers

NCT04128774

CCA2018-5-50 (Other Grant/Funding Number)

2019.554

NL71359.029.19 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 2 patient groups

GBM-dexa

Description:

Participants with clinical diagnosis of GBM, that require dexamethasone due to neurological deficits. Dose is based on the clinical judgement of the treating physician but should be given at least two weeks. Dexamethasone is given once a day.

Treatment:

Drug: Dexamethasone

GBM-control

Description:

Participants with clinical diagnosis of GBM not requiring dexamethasone treatment.