What is the mechanism of action of this treatment?

Mirtazapine, a treatment being studied for brain tumor patients, works by antagonizing central presynaptic alpha-2 adrenergic receptors, which increases the release of norepinephrine and serotonin. It also blocks serotonin receptors (5-HT2 and 5-HT3) and histamine receptors (H1). These actions help alleviate symptoms such as depression, nausea, and insomnia, which are common in brain tumor patients. This multi-faceted approach is important as it can improve the overall quality of life for these patients by addressing several debilitating symptoms simultaneously.

What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as chemotherapy and radiation therapy, often result in side effects like nausea, vomiting, fatigue, hair loss, and cognitive changes. Mirtazapine, an antidepressant being studied for its potential benefits in brain tumor patients, is known to cause sedation, increased appetite, weight gain, dry mouth, and dizziness. These side effects are important to consider when evaluating the overall treatment plan for brain tumor patients.

What prior FDA approvals exist?

FDA approvals for brain tumor treatments have primarily focused on chemotherapeutic agents, targeted therapies, and immunotherapies. Temozolomide (TMZ) is a commonly approved chemotherapeutic drug for glioblastoma, often used in combination with radiotherapy. Bevacizumab, an anti-VEGF antibody, has also been approved for recurrent glioblastoma. While mirtazapine itself is not approved for brain tumors, its potential benefits in managing depression, nausea, and weight loss in glioma patients undergoing TMZ therapy are being studied. This highlights the importance of supportive care medications in improving the quality of life for brain tumor patients.

What other types of research exist?

Promising novel alternatives to Mirtazapine for brain tumor patients include: <ol> <li>Temozolomide: An oral alkylating agent used in various phase II studies for brain metastases from lung cancer, melanoma, and breast cancer.</li> <li></li> </ol> Pembrolizumab: An immune checkpoint inhibitor (PD-1 pathway inhibitor) showing efficacy in patients with untreated brain metastases from non-small cell lung cancer. 3. Sunitinib: A tyrosine kinase inhibitor used in recurrent atypical meningioma. 4. Everolimus: An mTORC1 inhibitor used in combination with octreotide for aggressive meningiomas. 5. Nivolumab: A PD-1 blockade agent showing activity in recurrent atypical/anaplastic meningioma.

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Antidepressant

Mirtazapine for Brain Tumor

Phase 2

Waitlist Available

Led By Daniela Bota, MD PHD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

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

Must have

No prior treatment with temozolomide TMZ

Histologically confirmed diagnosis of glioma

Must not have

Known hypersensitivity to Mirtazapine and 5-HT3 receptor antagonists

Prior treatment with other chemotherapy drugs for glioma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial is testing whether mirtazapine can help reduce depression, nausea, vomiting, and weight loss in brain tumor patients undergoing chemotherapy. The study will monitor these patients over a period of time to see if their symptoms improve and if the medication is well-tolerated. Mirtazapine has been used to prevent chemotherapy-induced nausea and vomiting (CINV) and improve quality of life in cancer patients.

Who is the study for?

This trial is for adults over 18 with high-grade glioma who are about to start Temozolomide therapy and have not used it before. They must be able to perform daily activities at a moderate level (KPS of at least 60), understand English, sign consent forms, agree to use contraception, and have stopped antidepressants for a month.

What is being tested?

The study tests if Mirtazapine can help reduce depression, nausea, vomiting, and maintain weight in patients with brain tumors undergoing Temozolomide chemotherapy. It also checks how well patients tolerate the drug during treatment.

What are the potential side effects?

Possible side effects of Mirtazapine may include drowsiness, increased appetite leading to weight gain, dry mouth, constipation or diarrhea. Each patient's experience with side effects might vary.

Eligibility Criteria

Inclusion Criteria

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

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I have never been treated with temozolomide.

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My diagnosis is glioma, confirmed through tissue examination.

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I need some help with daily activities but can care for most of my personal needs.

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I am 18 or older and understand English well enough to comprehend consent forms and study materials.

Exclusion Criteria

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

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I am allergic to Mirtazapine and certain nausea medications.

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I have received chemotherapy for brain cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Depression level in glioma patients on temozolomide therapy treated with Mirtazapine

Frequency and grade of nausea and vomiting in depressed glioma patients on temozolomide therapy treated with Mirtazapine

Incidence of Treatment-Emergent Adverse Events

+1 more

Secondary study objectives

Frequency of dose modifications of mirtazapine

Percentage of adherence to mirtazapine regimen

Awards & Highlights

No Placebo-Only Group

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: mirtazapine in glioma patients treated with TemozolomideExperimental Treatment1 Intervention

Using the well-known Beck Depression Inventory, we will assess the changes in depression scores from baseline to after four and eight weeks of treatment with mirtazapine. We will also assess the change in nausea, vomiting, and weight at the same time points, and collect information on tolerability of mirtazapine throughout the course of the study.

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

Mirtazapine, a treatment being studied for brain tumor patients, works by antagonizing central presynaptic alpha-2 adrenergic receptors, which increases the release of norepinephrine and serotonin. It also blocks serotonin receptors (5-HT2 and 5-HT3) and histamine receptors (H1). These actions help alleviate symptoms such as depression, nausea, and insomnia, which are common in brain tumor patients. This multi-faceted approach is important as it can improve the overall quality of life for these patients by addressing several debilitating symptoms simultaneously.

Functional expression of the serotonin 5-HT7 receptor in human glioblastoma cell lines.Mirtazapine enhances frontocortical dopaminergic and corticolimbic adrenergic, but not serotonergic, transmission by blockade of alpha2-adrenergic and serotonin2C receptors: a comparison with citalopram.