What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, such as temozolomide and bevacizumab, often have side effects including nausea, vomiting, fatigue, and increased risk of infection due to bone marrow suppression. Temozolomide can also cause constipation, headache, and liver enzyme abnormalities. Bevacizumab may lead to hypertension, proteinuria, and increased risk of bleeding or thromboembolic events. Treatments like NEO100 (Perillyl Alcohol) are still under investigation, but potential side effects could include gastrointestinal disturbances and mild to moderate headaches, similar to other small-molecule drugs with anti-tumor properties.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, focusing on mechanisms such as inducing apoptosis and inhibiting tumor growth. Temozolomide, an oral alkylating agent, is commonly used in combination with radiotherapy and has shown efficacy in prolonging survival. Bevacizumab, an anti-VEGF monoclonal antibody, is approved for recurrent Glioblastoma and works by inhibiting angiogenesis. Additionally, Tumor Treating Fields (TTF) therapy, which uses electric fields to disrupt cancer cell division, has been approved for newly diagnosed and recurrent Glioblastoma. These treatments share some mechanistic similarities with NEO100, which is being studied for its potential anti-tumor properties.

What other types of research exist?

Promising novel alternatives to NEO100 for Glioblastoma patients include: 1) Tyrosine Kinase Inhibitors (TKIs) such as Alectinib and Ceritinib, which have shown efficacy in brain metastases from non-small cell lung cancer and may have potential in glioblastoma. 2) Antisense Oligonucleotide Therapy, such as Tofersen, which targets specific genetic mutations. 3) Immunotherapy agents like PD-1 inhibitors (e.g., Nivolumab) that have shown activity in recurrent high-grade meningiomas and may be applicable to glioblastoma. 4) mTORC1 inhibitors combined with other agents, such as Everolimus and Octreotide, which have shown promise in aggressive meningiomas and could be explored for glioblastoma.

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Monoterpene

Perillyl Alcohol for Glioblastoma

Phase 1 & 2

Recruiting

Research Sponsored by Neonc Technologies, Inc.

Eligibility Criteria Checklist

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

Must have

Have radiographically-confirmed progression of, or recurrent, primary or secondary Grade IV glioma, including infratentorial (brainstem, cerebellar) glioma (confirmed by biopsy) and subcortical glioma; or have radiographically-confirmed progression of, recurrent, primary or secondary Grade III astrocytoma.

All patients must be on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.

Must not have

Patient has had chemotherapy within 28 days prior to first administration of study drug.

Patient has had prior treatment with bevacizumab, a chemotherapy wafer implant (Gliadel), or any other FDA-approved chemotherapy except temozolomide.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing NEO100, a purified form of perillyl alcohol, to treat aggressive brain tumors in patients whose cancer has returned or not responded to other treatments. The treatment is given through the nose regularly and may help slow down tumor growth. Perillyl alcohol (POH) is a naturally occurring substance with properties that may inhibit tumor growth, and NEO100 is a highly purified version of POH currently being tested for glioblastoma treatment.

Who is the study for?

This trial is for patients with Grade IV glioma that has progressed after radiation or temozolomide treatment. They must have a life expectancy of at least three months, be in fair to good physical condition (ECOG 0-2 or KPS ≥60), and not have had recent surgery or chemotherapy. Participants need stable steroid use before consent, adequate organ function, and agree to contraception.

What is being tested?

NEO100 (perillyl alcohol) is being tested through nasal administration for its safety and effectiveness against recurrent Grade IV glioma. The study includes two phases: Phase 1 determines the maximum tolerated dose via a '3+3' design; Phase 2a treats patients with this dose. Up to six cycles of NEO100 are given daily over a period of four weeks each.

What are the potential side effects?

Specific side effects aren't listed but may include typical reactions related to cancer treatments such as irritation at the administration site, systemic reactions due to absorption of the drug, fatigue, nausea, headaches, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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My brain tumor has worsened or returned after treatment.

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I have been on a stable or decreasing dose of steroids for at least five days.

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My previous treatments with radiation or radiation combined with temozolomide did not work.

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I can take care of myself and perform daily activities.

Exclusion Criteria

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

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I have received chemotherapy in the last 28 days.

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I have been treated with specific cancer drugs before, but not temozolomide.

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My tumor is larger than 30mm and has multiple focal points.

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My cancer has come back or gotten worse more than once.

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I haven't had cancer, except for skin cancer, in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: NEO100 Phase 2AExperimental Treatment1 Intervention

Intranasal delivery of NEO100 (perillyl alcohol) four times a day. Treatment of total of 25 patients at maximum tolerated dose.

Group II: NEO100 Phase 1Experimental Treatment1 Intervention

Intranasal delivery of NEO100 (perillyl alcohol) four times a day, escalation up to four different doses to determine maximum tolerated dose.

0 / 9Eligibility 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 typically involve chemotherapy, radiation therapy, and novel agents like NEO100 (Perillyl Alcohol). Chemotherapy agents, such as temozolomide, damage the DNA of cancer cells, leading to their death. Radiation therapy uses high-energy particles to destroy cancer cells by causing DNA damage. Novel agents like NEO100 are being studied for their potential to induce apoptosis (programmed cell death) and inhibit tumor growth. These mechanisms are important for Glioblastoma patients as they guide the selection of effective treatments and help manage treatment expectations.

The Landscape of Novel Therapeutics and Challenges in Glioblastoma Multiforme: Contemporary State and Future Directions.