Memantine for Liver Cancer

Recruiting at 1 trial location

Overseen By Keary Jane't

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Inova Health Care Services

Disqualifiers: Child-Pugh A cirrhosis, Pregnancy, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests memantine, a medication commonly used for Alzheimer's disease, as a treatment for liver cancer that cannot be removed surgically or treated with intense therapy. The goal is to evaluate memantine's effectiveness and its impact on the quality of life for those with advanced liver cancer. Suitable candidates for this trial include individuals with newly diagnosed liver cancer that cannot be surgically removed and who are not candidates for aggressive treatment. Participants should have liver cancer that remains untreated, except for any treatments received over two years ago. As a Phase 2 trial, this research measures memantine's effectiveness in an initial, smaller group, allowing participants to contribute to potential advancements in liver cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients must be on a stable pain medication regimen for at least 10 days before starting the study.

Is there any evidence suggesting that memantine is likely to be safe for humans?

Research shows that memantine is generally safe for patients and has been used safely for conditions like Alzheimer's disease. While its effects on liver cancer are still under investigation, memantine's safety is well-documented from its use in other treatments.

In past studies with memantine, some patients experienced mild side effects like dizziness and headaches, while serious side effects were rare. The study's progression to later stages indicates that earlier research found the treatment safe enough for testing with more patients.

In this trial for liver cancer, researchers are carefully monitoring memantine to ensure its safety and effectiveness. As more information is gathered, a better understanding of its safety for liver cancer patients will emerge. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver cancer?

Memantine is unique because it’s being explored as a treatment for liver cancer, which is quite different from its usual use in managing Alzheimer's disease. Unlike standard treatments like surgery, chemotherapy, or targeted therapy, Memantine is an NMDA receptor antagonist. Researchers are excited about its potential because it might offer a new way to attack cancer cells without the severe side effects typical of more aggressive cancer therapies. This novel approach could provide an alternative for patients who cannot tolerate traditional treatments.

What evidence suggests that memantine might be an effective treatment for liver cancer?

Research has shown that memantine, a drug typically used for Alzheimer's disease, might also aid in treating liver cancer. Memantine blocks certain receptors in cells that can lead to tumor growth. Early results suggest it might slow or stop liver cancer in some patients. Although more evidence is needed specifically for liver cancer, this new approach offers hope for those unable to undergo more aggressive treatments. Participants in this trial will receive memantine to assess its effectiveness in treating liver cancer. Ongoing studies will determine its effectiveness, but the concept behind its use is promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Arthur Winer, MD

Principal Investigator

Inova Health Care Service

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have liver cancer that has not been treated yet, and it can be measured by scans.

My blood counts and organ functions are within normal ranges.

I am able to care for myself and perform daily activities.

Exclusion Criteria

I haven't had major surgery or a serious injury in the last 28 days.

I have brain metastases that are untreated or getting worse.

My cancer pain is under control with a stable pain medication plan for at least 10 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single agent memantine for efficacy evaluation in patients with unresectable, locally advanced, or metastatic HCC

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Memantine

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

Memantine is already approved in European Union, United States for the following indications:

Approved in European Union as Ebixa for:

• Alzheimer's disease

Approved in United States as Namenda for:

• Moderate to severe Alzheimer's disease

Approved in United States as Namenda XR for:

• Moderate to severe Alzheimer's disease

Approved in United States as Namzaric for:

• Moderate to severe Alzheimer's disease

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06007846?term=MEMANTINE&viewType=Table&rank=9

A Prospective Study of Memantine in Patients With ...

This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06007846

NCT06007846 | A Prospective Study of Memantine in ...

This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, ...

3.

withpower.com

withpower.com/trial/phase-2-and-3-carcinoma-6-2023-71bff?condition=liver+cancer&phaseList=Phase+3&overallStatus=Recruiting&hasNoPlacebo=false

Memantine for Liver Cancer

This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, ...

4.

ctv.veeva.com

ctv.veeva.com/study/a-prospective-study-of-memantine-in-patients-with-cirrhosis-and-liver-cancer

A Prospective Study of Memantine in Patients With Cirrhosis ...

This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, or metastatic ...

5.

ancora.ai

ancora.ai/it/details/NCT06007846

A Prospective Study of Memantine in Patients With ...

This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, or metast.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2762361/

Memantine: a review of studies into its safety and efficacy in ...

They found that even after a mean treatment time of 22.5 months, patients receiving combination therapy had significantly better outcomes than those receiving ...

7.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/567616

The Study of Atezolizumab, Bevacizumab and Memantine ...

The purpose of this research is to see the effect of triplet therapy with atezolizumab, bevacizumab, and memantine in treatment of your hepatocellular carcinoma ...