Evaluating Niacin for Glioblastoma Treatment

A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiotherapy and Temozolomide Followed by Monthly Temozolomide

This study is testing if adding Niacin CRT™ to the usual treatment can help newly diagnosed glioblastoma patients feel better while also looking at how much of the drug is safe to use.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: AHS Cancer Control Alberta (Academic / other)
• Drugs / interventions: Radiation, chemotherapy
• Locations: 1 site (Calgary, Alberta)
• Trial ID: NCT04677049 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the addition of Niacin CRT™ to the standard treatment regimen for newly diagnosed glioblastoma patients with IDH wild type. The study is divided into two phases: Phase I focuses on determining the maximum tolerated dose (MTD) of Niacin CRT™, while Phase II assesses its efficacy alongside concurrent radiation therapy and temozolomide. Blood samples will be collected to evaluate the immune response to Niacin CRT™ throughout the treatment process. The trial aims to improve patient tolerance to treatment and differentiate side effects from chemotherapy and Niacin CRT™.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed glioblastoma IDH wild type who are eligible for standard first-line treatment.

Not a fit: Patients with serious medical conditions or those unable to take oral medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes and tolerability for glioblastoma patients.

How similar studies have performed: Previous studies have shown promise with niacin in other contexts, but this specific application in glioblastoma is novel.

Eligibility 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. Patients that only had biopsy are included as long as pathology confirms the diagnoses and it is considered the maximal safe procedure for that patient.
* 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. 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.

Where this trial is running

Calgary, Alberta

• Tom Baker Cancer Centre — Calgary, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Gloria Roldan Urgoiti, MD — Tom Baker Cancer Centre
• Study coordinator: Gloria Roldan Urgoiti, MD

Conditions Glioblastoma IDH Wildtype; Glioblastoma