Study of Niacin in Glioblastoma

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single institution Phase I-II study to evaluate the tolerability and Maximum Tolerated Dose (MTD) (Phase I) and efficacy (Phase II) of adding Niacin CRT™ to standard first line treatment (concurrent Radiation Therapy (RT) and Temozolomide (TMZ) following by monthly TMZ - AKA Stupp protocol) in patients with newly diagnosed glioblastoma isocitrate dehydrogenase (IDH) wild type.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Collaborator: Tom Baker Cancer Centre
• Treatments: Niacin; Nicotinic Acids

Criteria

Inclusion Criteria:

• Adults, 18 years old to 75 years old inclusive.

• New diagnoses of glioblastoma IDH wild type.

• ECOG 0-2 (Appendix I).

• Candidates for concurrent standard first line treatment according to their Neuro-Oncologist and Radiotherapy Oncologist after maximal safe debulking neurosurgery.

• Adequate hematological, renal and hepatic function (see details in Section 4.1 of the protocol).

• Absence of known human immunodeficiency virus (HIV) infection, chronic hepatitis B or hepatitis C infection.

• Absence of any other serious medical condition according to the medical judgment of the Qualified Investigator prior to registration.

• Absence of any medical condition, which could interfere with oral medication intake.

• Signed informed consent.

• Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre.

• Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.

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.

• 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.