Status:
SUSPENDED
Study of Niacin in Glioblastoma
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Tom Baker Cancer Centre
Conditions:
Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 (co...
Detailed Description
During the Phase I stage Niacin CRT™ dose will be escalated every 4 weeks until the maximum tolerated dose (MTD) is determined. The MTD dose will be prescribed to patients during the Phase II stage. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04677049
Start Date
March 18 2021
End Date
December 31 2026
Last Update
January 2 2026
Active Locations (1)
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1
Tom Baker Cancer Centre/Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2