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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.

Select...

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

Select...

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.

Select...

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

Find a Location

Who is running the clinical trial?

Tannaz ArmaghnayLead Sponsor

Tannaz ArmaghanyLead Sponsor

1 Previous Clinical Trials

6 Total Patients Enrolled

Tannaz Armaghany, MDPrincipal InvestigatorBaylor College of Medicine

3 Previous Clinical Trials

83 Total Patients Enrolled

Media Library

Meclizine (CAR Inverse Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03253289 — Phase 1

Hepatocellular Carcinoma Research Study Groups: Meclizine 100 mg

Meclizine (CAR Inverse Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03253289 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the recruitment quota for this research study?

"That is correct. In accordance with information hosted on clinicaltrials.gov, this trial which was first unveiled on October 13th 2017, is accepting applicants. A total of 16 patients will be recruited from 7 different sites."

Answered by AI

Is there still capacity for participants in this research program?

"According to clinicaltrials.gov, this trial is open for recruitment and has been since October 13th 2017; the information was most recently revised on July 19th 2022."

Answered by AI

Is Meclizine Oral Tablet a risk-free option for individuals seeking treatment?

"Since this is a Phase 1 trial, the safety of Meclizine Oral Tablet can only be estimated at level one due to limited clinical data supporting both its efficacy and security."

Answered by AI

Have any other clinical experiments examined the efficacy of Meclizine Oral Tablet?

"Currently, there is 1 clinical trial evaluating the effectiveness of Meclizine Oral Tablet. This study has not advanced past Phase 3 yet and is primarily being conducted in Houston, Texas with a total of 7 sites involved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Meclizine for Hepatocellular Carcinoma

Tannaz Armaghnay 2017. "Meclizine for Hepatocellular Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03253289.

All > Hcc > Hepatocellular Carcinoma