Study of Niacin in Glioblastoma
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|ClinicalTrials.gov Identifier: NCT04677049|
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : March 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype||Drug: Niacin CRT||Phase 1 Phase 2|
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.
During the Phase I study a sample of blood at baseline, at each level dose of Niacin CRT™, and every two months during the maintenance phase while on Niacin CRTTM will be sent to a lab to evaluate the peripheral activity of Niacin CRT™ in innate immune system cells. These samples will be taken at the time of routine standard of care lab work.
Based on prior clinical trials evaluating niacin extended release formulation for the management of dyslipidaemias there is vast experience on dose escalation of niacin. One of the main side effects is flushing that is ameliorated by escalating doses in intervals no shorter than 4 weeks and usually decreases with time.
Following this schema, there is no increase in dose coinciding with TMZ while administered in a 5/28 days schedule (given daily for 5 days of each 28-day cycle). This will not only improve tolerance but also will allow us to differentiate potential adverse events from chemotherapy from the ones from Niacin CRT™.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiotherapy and Temozolomide Followed by Monthly Temozolomide|
|Actual Study Start Date :||March 18, 2021|
|Estimated Primary Completion Date :||January 2026|
|Estimated Study Completion Date :||January 2026|
Niacin controlled release technology (CRT):
Niacin CRT™ is to be started 7 days before concurrent Radiation Therapy (RT)- Temozolomide (TMZ) treatment.
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.
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.
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.
Drug: Niacin CRT
A controlled release technology (CRT) tablet of Niacin
- Determining the Maximum Tolerated Dose [ Time Frame: Up to 24 weeks after registration onto the study ]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).
- Evaluating if Niacin CRT Improves Glioblastoma Survival Rates [ Time Frame: 6 months after determining the maximum tolerated dose which can last up to 24 weeks after registration onto the study ]To evaluate if adding Niacin CRT to current standard first line treatment of GB improves progression free survival (PFS) at 6 months.
- Effect of Niacin CRT in Peripheral Monocytes [ Time Frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years. ]To evaluate the effect of Niacin CRT in peripheral monocytes by comparing control monocytoid cells to those that have been treated with Niacin.
- Response Rate Associated with Niacin [ Time Frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years. ]To determine the response rate associated with the investigational regimen.
- Overall Survival Rate Associated with Niacin [ Time Frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years. ]To determine the overall survival (OS) associated with the investigational regimen.
- Quality of Life While on Study using EORTC QLQ-C30 Questionnaires [ Time Frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years. ]To determine Quality of Life (QOL) that will be evaluated throughout the study using EORTC QLQ-C30 questionnaires.
- Quality of Life While on Study using EORTC BN-20 Questionnaires [ Time Frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years. ]To determine Quality of Life (QOL) that will be evaluated throughout the study using EORTC BN-20 questionnaires.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677049
|Contact: Gloria Roldan Urgoiti, MD||403-521-3688||Gloria.RoldanUrgoiti@ahs.ca|
|Contact: Amy Abelemail@example.com|
|Tom Baker Cancer Centre||Recruiting|
|Calgary, Alberta, Canada, T2N 4N2|
|Contact: Gloria Roldan Urgoiti, MD 403-521-3688 Gloria.RoldanUrgoiti@ahs.ca|
|Contact: Mahsa Alaee Mahsa.Alaee@ahs.ca|
|Principal Investigator:||Gloria Roldan Urgoiti, MD||Tom Baker Cancer Centre|
|Responsible Party:||AHS Cancer Control Alberta|
|Other Study ID Numbers:||
|First Posted:||December 21, 2020 Key Record Dates|
|Last Update Posted:||March 23, 2023|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents