Clinical trial · Interventional
Study of Niacin in Glioblastoma
A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiotherapy and Temozolomide Followed by Monthly Temozolomide
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Niacin CRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Niacin
- description
- Niacin controlled release technology (CRT): Niacin CRT™ is to be started 7 days before concurrent Radiation Therapy (RT)- Temozolomide (TMZ) treatment. Chemo/Radiation Therapy: For all patients, regardless of the phase of the study, concurrent RT and TMZ for 6 weeks followed by 6-12 cycles of monthly TMZ will be given. Concurrent Temozolomide: TMZ will be administered from the first to the last day of RT at 75 mg/m2 orally (PO) for a maximum of 49 days. Monthly Temozolomide: Cycles of chemotherapy Day 1 to Day 5 every 28 days will start 28 days (+/- 2 days) after the end of RT-TMZ. First cycle of TMZ is administered at 150 mg/m2 Day 1-Day 5 by mouth (PO) and increased to 200 mg/m2 Day 1-Day 5 PO from cycle 2 onwards if well tolerated. While 6 cycles are standard of care, the Neuro-Oncologist may continue up to 12 cycles if clinically appropriate.
- interventionNames
- Drug: Niacin CRT
Primary outcomes (2)
- measure
- Determining the Maximum Tolerated Dose
- timeFrame
- Up to 24 weeks after registration onto the study
- description
- To evaluate and determine maximum tolerated dose (MTD) of Niacin CRT added to concurrent radiotherapy (RT) and temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GB).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDPoon CC, Hagen KM, Sarkar S, Mirzaei R, Silva C, Ueno A, de Robles P, Roldan-Urgoiti G, Yong VW. Niacin Modulates Immune Responses in a Phase I Dose-Escalation Clinical Trial of Newly Diagnosed Glioblastoma. Neurol Neuroimmunol Neuroinflamm. 2026 Mar;13(2):e200530. doi: 10.1212/NXI.0000000000200530. Epub 2026 Feb 3. PMID 41632924
- DERIVEDRoldan Urgoiti G, de Robles P, Tsang RY, Willson M, Ghosh S, Faruqi M, Lim G, Loewen S, Nordal R, Cairncross G, Leckie C, Poon CC, Yong VW. A phase I-II study of niacin in patients with newly diagnosed glioblastoma: safety and interim phase II analysis. J Neurooncol. 2025 Nov 28;176(1):101. doi: 10.1007/s11060-025-05351-z. PMID 41313494