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Niacin CRT for Glioblastoma

Phase 1 & 2
Recruiting
Led By Gloria Roldan Urgoiti, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
New diagnoses of glioblastoma IDH wild type
Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines niacin with radiation and chemotherapy. The goal is to find out if it is safe and effective for treating glioblastoma.

Who is the study for?
This trial is for adults aged 18-75 with a new diagnosis of glioblastoma IDH wild type, who've had surgery to remove as much tumor as possible. They must be fit for standard cancer treatment and agree to use effective birth control. Excluded are those with certain health conditions like active heart disease, gout, liver disease, or prior treatments for glioblastoma.Check my eligibility
What is being tested?
The study tests the safety and maximum dose (Phase I) and effectiveness (Phase II) of Niacin CRT added to the Stupp protocol (standard radiation therapy plus Temozolomide chemotherapy), in treating newly diagnosed glioblastoma without IDH mutation.See study design
What are the potential side effects?
Potential side effects may include reactions related to niacin such as skin flushing or gastrointestinal issues. Since it's combined with standard treatments, other side effects can include fatigue, nausea, hair loss from radiation therapy and low blood cell counts from chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My glioblastoma is IDH wild type.
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I am using a highly effective method of birth control.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I can take pills without any issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determining the Maximum Tolerated Dose
Glioblastoma
Secondary outcome measures
Effect of Niacin CRT in Peripheral Monocytes
Overall Survival Rate Associated with Niacin
Quality of Life While on Study using EORTC BN-20 Questionnaires
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: NiacinExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,153 Total Patients Enrolled
7 Trials studying Glioblastoma
350 Patients Enrolled for Glioblastoma
Tom Baker Cancer CentreOTHER
29 Previous Clinical Trials
8,796 Total Patients Enrolled
1 Trials studying Glioblastoma
10 Patients Enrolled for Glioblastoma
Gloria Roldan Urgoiti, MDPrincipal InvestigatorTom Baker Cancer Centre
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Niacin CRT Clinical Trial Eligibility Overview. Trial Name: NCT04677049 — Phase 1 & 2
Glioblastoma Research Study Groups: Niacin
Glioblastoma Clinical Trial 2023: Niacin CRT Highlights & Side Effects. Trial Name: NCT04677049 — Phase 1 & 2
Niacin CRT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04677049 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a person is over 35 years old, can they still participate in this research project?

"Eligible patients for this study must be aged 18-75. There are currently 35 clinical trials underway for people younger than 18 and 441 for senior citizens."

Answered by AI

How does one go about signing up for this trial?

"Up to 59 people with glioblastoma who meet the following requirements can be admitted into this trial: new diagnoses of glioblastoma IDH wild type, absence of known human immunodeficiency virus (HIV) infection, chronic hepatitis b or hepatitis c infection, ECOG 0-2 , ability to take oral medication, and being accessible for treatment and follow-up at the participating centre."

Answered by AI

What conditions commonly warrant a Niacin CRT prescription?

"Niacin CRT is often employed to mitigate cardiovascular risk. Additionally, it has therapeutic value for treating dyslipidemias, lipidemia, and the potential onset of pancreatitis."

Answered by AI

What are the key goals that researchers hope to achieve with this trial?

"The primary outcome for this study, which will be assessed over a period of 6 months after treatment begins (which can last up to 24 weeks), is Determining the Maximum Tolerated Dose. Secondary outcomes include Response Rate Associated with Niacin and Effect of Niacin CRT in Peripheral Monocytes, which will be evaluated by comparing control monocytoid cells to those that have been treated with Niacin. Quality of Life While on Study using EORTC BN-20 Questionnaires will also be monitored throughout the study in order to determine any changes in quality of life."

Answered by AI

How many people fit the requirements to participate in this clinical trial?

"That is correct. Information available on clinicaltrials.gov affirms that this study began recruiting on March 18th, 2021 and is still actively looking for 59 participants at a single location."

Answered by AI

Are we able to enroll more patients in this research project?

"Yes, this information can be found on clinicaltrials.gov. The trial was posted on 3/18/2021 and last updated 7/18/2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Niacin in Glioblastoma
2021. "Study of Niacin in Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04677049.
~21 spots leftby Jan 2026
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