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

Trial Summary

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.

What is the purpose of this trial?

This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, or metastatic HCC otherwise not deemed candidates for intensive systemic therapy. In addition to the primary endpoint and multiple secondary efficacy endpoints, we will describe changes in quality of life on treatment over time.

Research Team

Arthur Winer, MD

Principal Investigator

Inova Health Care Service

Eligibility Criteria

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.

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

My cancer is advanced and cannot be removed with surgery, as agreed by a team of cancer experts.

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

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

Treatment Details

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.

Participant Groups

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+