What side effects are associated with this type of intervention?

The most common treatments for glioblastoma, including temozolomide and radiation therapy, are associated with several side effects. Temozolomide can cause nausea, vomiting, fatigue, and myelosuppression, which can lead to an increased risk of infection. Radiation therapy can result in fatigue, hair loss at the treatment site, skin changes, and potential neurotoxicity, which may manifest as cognitive decline. Combining these treatments can amplify these side effects, necessitating careful management and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for glioblastoma, with temozolomide being a cornerstone. Temozolomide, an oral alkylating agent, is often used concomitantly with radiation therapy and as an adjuvant treatment. This combination has been shown to improve survival rates in glioblastoma patients. Additionally, bevacizumab, an anti-VEGF monoclonal antibody, has been approved for recurrent glioblastoma due to its ability to inhibit tumor blood vessel growth. These treatments form the basis of current standard care, which the NG101m trial aims to enhance with additional adjuvant therapy.

What other types of research exist?

Promising novel alternatives to NG101m for glioblastoma multiforme patients include: 1) Ivosidenib, a mutant-IDH1 inhibitor, which has shown tolerability and potential efficacy in clinical trials. 2) Vorasidenib, a dual mutant-IDH1/2 inhibitor, currently in phase III testing. Both therapies target IDH mutations and may offer new avenues for treatment in 2024.

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NG101m Adjuvant Therapy for Glioblastoma

Phase 1 & 2

Waitlist Available

Research Sponsored by NeuGATE Theranostics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary treatment must consist of a chemoradiation therapy (CRT) regimen

Must not be on any other alternative therapies

Must not have

Corticosteroid therapy that cannot be tapered down to a dose of 1 - 2 mg/day of dexamethasone or its equivalent

History of peptic ulcer disease or gastrointestinal perforation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if adding NG101m capsules to standard brain cancer treatments can help patients with newly diagnosed glioblastoma multiforme live longer. NG101m is expected to make chemotherapy and radiation more effective.

Who is the study for?

This trial is for adults over 18 with newly diagnosed glioblastoma who are set to start chemoradiation therapy. They must have certain blood and organ function levels, not be pregnant or breastfeeding, and can't be on other therapies or have specific allergies or diseases like immunodeficiency or autoimmune disorders.

What is being tested?

The trial tests NG101m capsules as an add-on to the standard glioblastoma treatment, which includes temozolomide chemotherapy and intensity-modulated radiation therapy. The goal is to see if adding NG101m improves outcomes.

What are the potential side effects?

Potential side effects of NG101m aren't specified here but may include reactions related to vitamin A, D3, L-citrulline (its components), plus common cancer treatment side effects from chemo and radiation such as fatigue, nausea, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My main treatment is a combination of chemotherapy and radiation.

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I am not using any alternative therapies.

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I am able to care for myself but may not be able to do active work.

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I have been recently diagnosed with glioblastoma.

Exclusion Criteria

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

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I cannot reduce my steroid medication to a low dose.

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I have had a peptic ulcer or a hole in my digestive tract.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate.

Number of participants with treatment-emergent adverse events and serious adverse events

Secondary study objectives

Progression-free survival (PFS)

Quality of Life (QoL)

Response assessment in neuro-oncology (RANO) criteria

Other study objectives

Identify and quantify immune/effector cells

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: NG101m and standard treatmentExperimental Treatment3 Interventions

Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity-modulated radiation therapy

2006

Completed Phase 3

~1240

Temozolomide

2010

Completed Phase 3

~1880

0 / 6Eligibility 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

The most common treatments for Glioblastoma include temozolomide and radiation therapy. Temozolomide is an alkylating agent that damages DNA in tumor cells, leading to cell death, while radiation therapy uses high-energy rays to destroy cancer cells by damaging their DNA. These treatments are often used together to maximize their effectiveness. The addition of NG101m as an adjuvant therapy aims to further enhance the efficacy of this standard treatment regimen, potentially improving outcomes for glioblastoma patients by making the tumor more susceptible to the effects of temozolomide and radiation.