What side effects are associated with this type of intervention?

Common treatments for Hepatocellular Carcinoma (HCC) include systemic therapies like sorafenib and lenvatinib, which can cause hypertension, diarrhea, fatigue, hand-foot skin reactions, and liver dysfunction. Immune checkpoint inhibitors may lead to immune-related adverse events such as colitis, hepatitis, pneumonitis, and endocrinopathies. Locoregional therapies like transarterial chemoembolization (TACE) can result in post-embolization syndrome, liver dysfunction, and rarely, liver abscesses. Radioembolization may cause fatigue, abdominal pain, and radiation-induced liver disease. The side effect profile of Meclizine hydrochloride as a CAR inverse agonist in HCC is not well-established but may include drowsiness and dry mouth.

What prior FDA approvals exist?

The FDA has approved several treatments for hepatocellular carcinoma (HCC), including sorafenib (Nexavar), a multitargeted tyrosine kinase inhibitor, and atezolizumab plus bevacizumab, which has shown survival benefits in advanced HCC. While Meclizine hydrochloride is being studied as a CAR inverse agonist, there are no current FDA-approved CAR inverse agonists for HCC. Other approved treatments focus on targeting molecular pathways, such as kinase inhibitors and immune checkpoint inhibitors.

What other types of research exist?

Promising novel alternatives to Meclizine hydrochloride for HCC patients include: 1) Sorafenib combined with MEK inhibitors like AZD6244, which enhances anti-tumor activity and induces apoptosis. 2) Pimozide, which promotes reversible proliferative suppression and has additive activity with sorafenib. 3) Doxorubicin drug-eluting bead transarterial chemoembolization (TACE), which has shown efficacy and safety in advanced HCC. 4) Neoadjuvant cabozantinib and nivolumab, which have converted locally advanced HCC into resectable disease with enhanced antitumor immunity.

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CAR Inverse Agonist

Meclizine for Liver Cancer (OPTIM Trial)

Phase 1

Waitlist Available

Led By Tannaz Armaghany, MD

Research Sponsored by Tannaz Armaghnay

Eligibility Criteria Checklist

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

Must have

Patients must have imaging: CT or MRI abdomen with and without contrast confirmed or highly suspicious for Hepatocellular carcinoma

ECOG Performance status less than/equal to 2 (Karnofsky greater than 60%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day1 and last day of treatment(last day would be one time point between day 28 and day 35 of treatment)

Awards & highlights

OPTIM Trial Summary

This trial is testing whether meclizine, which is typically used for vertigo and motion sickness, could also have therapeutic benefits for patients with hepatocellular carcinoma. The effects of meclizine will be analyzed by measuring the messenger RNA levels of certain genes.

Who is the study for?

This trial is for adults over 18 with confirmed Hepatocellular carcinoma who haven't had treatment for it yet. They need normal organ/marrow function, measurable disease, and a life expectancy of at least 10 weeks. Candidates must be eligible for certain cancer treatments like surgery or ablation but not liver transplant or other investigational drugs.Check my eligibility

What is being tested?

The trial tests Meclizine, an antihistamine used against vertigo and motion sickness, as a potential therapy for liver cancer by acting as a CAR inverse agonist to block tumor growth and induce cell death. Its effects will be measured through changes in specific gene expressions.See study design

What are the potential side effects?

Potential side effects of Meclizine may include drowsiness, dry mouth, blurred vision, constipation or urinary retention due to its antihistamine properties. The risk of severe allergic reactions is present if there's a history of allergies to similar medications.

OPTIM Trial Eligibility Criteria

Inclusion Criteria

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

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My scans show signs of liver cancer.

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I can take care of myself but might not be able to do heavy physical work.

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I am eligible for surgery or other specific treatments for my condition.

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My cancer can be measured and was confirmed by a scan within the last 8 weeks.

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I have never received treatment for my liver cancer on the lesion to be biopsied.

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I am over 18 years old.

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My liver cancer diagnosis was confirmed with a biopsy.

OPTIM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day1 and last day of treatment(last day would be one time point between day 28 and day 35 of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day1 and last day of treatment(last day would be one time point between day 28 and day 35 of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day1 and last day of treatment(last day would be one time point between day 28 and day 35 of treatment) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Body Weight Changes

Secondary outcome measures

A panel of CAR downstream target genes

Change in Ki-67 proliferation index

Change in Serum AFP

+3 more

OPTIM Trial Design

1Treatment groups

Experimental Treatment

Group I: Meclizine 100 mgExperimental Treatment1 Intervention

Meclizine 50 mg will be taken by the patient orally twice daily for a total of 28 days(up to 35 days).

0 / 7Eligibility 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

Common treatments for Hepatocellular Carcinoma (HCC) include targeted therapies, immunotherapies, and antiviral therapies. Sorafenib, a tyrosine kinase inhibitor, blocks RAF kinase and VEGFR, disrupting tumor cell proliferation and angiogenesis. Immunotherapies, such as immune checkpoint inhibitors, enhance the body's immune response against cancer cells. Antiviral therapies, particularly for HBV and HCV-related HCC, aim to reduce viral load and liver inflammation, potentially improving overall survival. Meclizine hydrochloride, studied as a CAR inverse agonist, may inhibit tumorigenesis and induce apoptosis by affecting CAR target genes. Understanding these mechanisms helps tailor treatments to disrupt cancer growth and improve patient outcomes.

Latest developments in targeted therapy for hepatocellular carcinoma.