What side effects are associated with this type of intervention?

Common treatments for glioblastoma, such as concurrent radiation therapy (RT) and Temozolomide (TMZ), are associated with several side effects. Radiation therapy can lead to neurocognitive dysfunction, fatigue, and potential damage to surrounding brain tissue. Temozolomide, an alkylating agent, may cause myelosuppression, leading to increased risk of infections, as well as nausea, vomiting, and potential reproductive toxicity. Additionally, there is a risk of nephrotoxicity and gastrointestinal disturbances. These treatments aim to manage the tumor but come with significant risks that need to be monitored closely.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, focusing on various mechanisms of action. Temozolomide, an oral alkylating agent, is commonly used in combination with radiation therapy (Stupp protocol) and has shown efficacy in extending survival. Bevacizumab, an anti-VEGF monoclonal antibody, is approved for recurrent Glioblastoma due to its ability to inhibit angiogenesis. Lomustine, another alkylating agent, is often used in combination regimens. While Niacin CRT™ is being studied for its potential to modulate cellular metabolism and provide anti-inflammatory and neuroprotective effects, similar metabolic modulators or anti-inflammatory agents have not yet been specifically approved for Glioblastoma by the FDA.

What other types of research exist?

Promising novel alternatives to Niacin CRT™ for Glioblastoma patients include: 1) Vismodegib, a Smoothened (SMO) inhibitor that targets the sonic hedgehog (SHH) pathway, showing efficacy in reducing tumor burden. 2) Selumetinib, a MEK inhibitor, which has shown positive responses in pediatric low-grade gliomas and may be applicable to glioblastoma. 3) Pembrolizumab, an immune checkpoint inhibitor, which has demonstrated efficacy in various cancers and is being explored for glioblastoma. 4) Bevacizumab, an anti-VEGF antibody, which has been used to manage glioblastoma by inhibiting angiogenesis. These alternatives are based on their mechanisms of action and recent clinical trial outcomes.

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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

Must not have

Active peptic ulcer or active gastrointestinal bleeding

Patients unfit for any treatment component, including contraindications for radiotherapy or Connective Tissue Disease

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

No Placebo-Only Group

Summary

This study is evaluating whether a new drug called Niacin CRT™ can improve the survival of people with 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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an active stomach ulcer or bleeding in my digestive tract.

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I am not fit for certain treatments due to health issues.

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My brain tumor is identified as glioblastoma with an IDH mutation.

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I cannot stop taking my cholesterol medication before starting a new treatment.

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I have liver disease or unexplained high liver enzyme levels.

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I experience pain and swelling from gout.

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I have received any treatment or radiotherapy for glioblastoma.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determining the Maximum Tolerated Dose

Glioblastoma

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma treatments primarily include surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible, reducing the tumor burden. Radiation therapy uses high-energy beams to kill cancer cells and shrink tumors, targeting residual cells post-surgery. Chemotherapy, particularly with temozolomide, works by damaging the DNA of cancer cells, inhibiting their ability to replicate. Treatments like Niacin CRT™ are being studied for their ability to modulate cellular metabolism and provide anti-inflammatory and neuroprotective effects, which could potentially enhance the efficacy of standard treatments and improve patient outcomes by targeting the tumor environment and reducing treatment-related side effects.