Memantine for Liver Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byArthur Winer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Inova Health Care Services

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

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

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.

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.

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 18 years old or older.

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

See 6 more

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.

See 10 more

Trial 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 (Other)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention