Using memantine to treat patients with cirrhosis and liver cancer

A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma

This study is testing if memantine can help improve the health and quality of life for patients with liver cancer who can't have major treatments due to cirrhosis.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Inova Health Care Services (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Fairfax, Virginia and 1 other locations)
• Trial ID: NCT06007846 on ClinicalTrials.gov

What this trial studies

This prospective study aims to evaluate the efficacy of memantine in patients with unresectable hepatocellular carcinoma (HCC) who are not suitable candidates for intensive systemic therapy. The study will assess primary and secondary efficacy endpoints, as well as monitor changes in patients' quality of life over time while undergoing treatment. Participants must have a confirmed diagnosis of HCC and a Child-Pugh cirrhosis score of B7 or greater. The study is conducted at a single site, the Inova Schar Cancer Institute in Virginia.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with newly diagnosed, untreated hepatocellular carcinoma and significant cirrhosis.

Not a fit: Patients with early-stage liver cancer or those who are candidates for aggressive systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer who currently have limited treatment choices.

How similar studies have performed: While this approach is novel in the context of liver cancer, similar studies using memantine for other conditions have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Age 18 or older.
2. Patients have newly diagnosed and previously untreated, histologically or radiologically confirmed hepatocellular carcinoma with at least one lesion that is measurable by RECIST 1.1 criteria. A prior HCC lesion that was treated surgically or by radiation is allowed as long as it was at least 2 years or more from the current HCC diagnosis.
3. Patient's cancer must be deemed locally advanced and unresectable as per the consensus of the Inova Multidisciplinary Cancer Care Conference.
4. Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a candidate for aggressive systemic treatment.
5. Eastern Cooperative Oncology Group Performance Status of 0-2.
6. Patients must have adequate blood counts and organ function.
7. Memantine is harmful to the human fetus. For this reason, sexually active males with partners of childbearing potential must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study. Women of child bearing potential must have a negative serum pregnancy test result within 24 hours prior to initiation of study treatment. They must also agree to use agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study.
8. Patients must demonstrate ability to understand and the willingness to sign a written informed consent document.
9. Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.

Exclusion Criteria:

1. Patients with Child-Pugh A cirrhosis.
2. Female patients who are pregnant or breast-feeding.
3. Concomitant illness or history that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
4. Life-threatening intercurrent illness.
5. Anticipated poor compliance.
6. Subject is enrolled in a separate interventional clinical trial.
7. Active tuberculosis.
8. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
9. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
10. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry for at least 10 days prior to study entry.
11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment.
12. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
13. Patients undergoing other anti-cancer treatment. Palliative radiation for symptom control will be allowed while on protocol.

Where this trial is running

Fairfax, Virginia and 1 other locations

• Inova Schar Cancer Institute — Fairfax, Virginia, United States (RECRUITING)
• Inova Health Care Service — Falls Church, Virginia, United States (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Arthur Winer, MD — Inova Health Care Service
• Study coordinator: Elahe Mollapour

Conditions: Hepatocellular Carcinoma, Cirrhosis