Study of Niacin in Glioblastoma

Exclusion Criteria

• •Glioblastoma, IDH-mutant.
• •Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Additionally, any low grade or low risk malignancy not requiring treatment will not exclude a patient from participation in the trial.
• •Known hypersensitivity to niacin.
• •Inability to provide informed consent.
• •Active liver disease or unexplained persistent elevations of serum transaminases.
• •Active peptic ulcer or active gastrointestinal bleeding.
• •Unstable angina or myocardial infarction within 6 months.
• •Symptomatic gout.
• •Patients on 3-hydroxy-3-methylglutaryl-coenzyme (HMG-COA reductase) inhibitors that cannot discontinue them at least 2 weeks before starting Niacin CRT™.
• •Any prior systemic treatment for glioblastoma (standard, evidence based or experimental) or radiotherapy/radiosurgery.
• •Individuals with MRI non-compatible metal in the body, or unable to undergo MRI procedures including allergy to gadolinium.
• •Patients unfit for any treatment component, including contraindications for radiotherapy or Connective Tissue Disease.
• •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• •Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial.
• •Pregnant, breast-feeding, unable and/or unwilling to use contraception methods.