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Memantine for Liver Cancer

Phase 2 & 3

Recruiting

Led By Arthur Winer, MD

Research Sponsored by Inova Health Care Services

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years from the initial visit

Awards & highlights

Study Summary

This trial looks at the effects of a single med, memantine, on people with advanced liver cancer who cannot have other treatments. We'll measure effects on quality of life too.

Who is the study for?

This trial is for adults over 18 with advanced, inoperable liver cancer (hepatocellular carcinoma) who haven't had intensive systemic therapy. They must have a specific level of cirrhosis (Child-Pugh score B7+), be able to perform daily activities with minimal help, and agree to use contraception if there's any chance of pregnancy.Check my eligibility

What is being tested?

The study tests the drug Memantine (Namenda) on patients with liver cancer that can't be removed by surgery. It aims to see how effective the drug is and its impact on quality of life over time. Participants will receive Memantine as a single agent treatment.See study design

What are the potential side effects?

While not specified here, common side effects of Namenda may include dizziness, headache, confusion, constipation. Since it's being tested in people with liver issues, monitoring for worsening liver function or other organ-related problems would also be important.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years from the initial visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years from the initial visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years from the initial visit for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Patients Progression Free Survival at 6 months

Other outcome measures

Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire for cancer (EORTC QLQ-C30)

Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC-HCC18) over treatment

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004

23%

Sleepiness/Sedation

10%

Headache

Tension/Inner Unrest

Reduced Salivation

Concentration Difficulties

Diminished Sexual Drive

Asthenia/Lassitude/Increased Fatigability

Constipation

Polyuria/Polydipsia

Orthostatic Dizziness

Nausea/Vomiting

Erectile Dysfunction

Failing Memory

Diarrhea

Increased Duration of Sleep

Reduced Duration of Sleep

Increased Dream Activity

Accomodation Disturbance

Increased Tendancy to Sweating

Weight Gain

Ejaculatory Dysfunction

Micturtion Disturbances

100%

80%

60%

40%

20%

Study treatment Arm

Escitalopram and Placebo

Escitalopram and Memantine

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Namenda

2004

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Inova Health Care ServicesLead Sponsor

69 Previous Clinical Trials

22,243 Total Patients Enrolled

Arthur Winer, MDPrincipal InvestigatorInova Health Care Service

Frequently Asked Questions

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

How many people have enrolled in this research endeavor thus far?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first published on July 31st 2023 is currently enrolling patients. Two distinct medical centres are seeking 12 individuals to participate in the study."

Answered by AI

Are participants being accepted into this medical research project?

"Affirmative. Based on the information available via clinicaltrials.gov, this medical trial is currently in recruitment mode and was initially posted on July 31st 2023. The study requires 12 individuals from two different sites to take part."

Answered by AI

Recent research and studies

The LancetJournal

Lenvatinib Versus Sorafenib in First-line Treatment of Patients with Unresectable Hepatocellular Carcinoma: A Randomised Phase 3 Non-inferiority Trial

Kudo, Masatoshi, Richard S Finn, Shukui Qin, Kwang-Hyub Han, Kenji Ikeda, Fabio Piscaglia, Ari Baron, et al.. 2018. “Lenvatinib Versus Sorafenib in First-line Treatment of Patients with Unresectable Hepatocellular Carcinoma: A Randomised Phase 3 Non-inferiority Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(18)30207-1.

The LancetJournal

Nivolumab in Patients with Advanced Hepatocellular Carcinoma (checkmate 040): An Open-label, Non-comparative, Phase 1/2 Dose Escalation and Expansion Trial

El-Khoueiry, Anthony B, Bruno Sangro, Thomas Yau, Todd S Crocenzi, Masatoshi Kudo, Chiun Hsu, Tae-You Kim, et al.. 2017. “Nivolumab in Patients with Advanced Hepatocellular Carcinoma (checkmate 040): An Open-label, Non-comparative, Phase 1/2 Dose Escalation and Expansion Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(17)31046-2.

New England Journal of MedicineJournal

Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma

Finn, Richard S., Shukui Qin, Masafumi Ikeda, Peter R. Galle, Michel Ducreux, Tae-You Kim, Masatoshi Kudo, et al.. 2020. “Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1915745.

European Journal of CancerJournal