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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing a new way to administer a drug, perillyl alcohol, to patients with brain tumors. The goal is to see if it is safe and effective. Up to 24 patients will be enrolled in the first phase of the trial, and 25 in the second phase. The drug will be administered four times a day for 28 days, and patients will be monitored for side effects and effectiveness.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1 : Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Phase 2 : Number of Participants Who Are Alive Each Month For 6 Months

Phase 2 : Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related To Treatment

Side effects data

From 2009 Phase 2 trial • 89 Patients • NCT00608634

52%

Mild Rash, Redness, Erythema

SCC in treatment area

Bowel Obstruction

BCC outside of treatment area

SCC outside of treatment area

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Low Dose POH 0.3%

High Dose POH 0.76%

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 / 4Eligibility 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.