Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Glioma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

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.

Participants with clinical diagnosis of GBM not requiring dexamethasone treatment.

The case group receives dexamethasone based on the clinical indication.

Mathilde CM Kouwenhoven, MD, PhD

Juan JJ Vallejo, PhD

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.

Function and Composition of Regulatory B Cells in Participants With Glioblastoma

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

Data will be stored in coded form in a Castor database. At this moment data will not be available to other researchers.

ldentify if dexamethasone treatment alters the frequency and functionality of atypic B cells (CD25+CD95Fas+-B cells) in blood in GBM.

Changes in the frequency and functionality of regulatory B cells in blood after two weeks of treatment with dexamethasone.

Changes in the frequency and functionality of regulatory B cells in blood in patients not treated with dexamethasone.

Amsterdam UMC, location VUmc

Neurologist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Function and Composition of Regulatory B Cells in Participants With Glioblastoma	NCT04128774	Glioblastoma, A...	Dexamethasone	18 Years -	Amsterdam UMC, location VUmc
Function and Composition of Regulatory B Cells in Participants With Glioblastoma	NCT04128774	Glioblastoma, A...	Dexamethasone	18 Years -	Amsterdam UMC, location VUmc

Spots Global Cancer Trial Database for regulatory b cells