RECRUITING

A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-31

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06007846

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Elahe Mollapour

CONTACT

571-472-0615

elahe.mollapour@inova.org

Keary Jane't

CONTACT

571-472-0234

keary.janet@inova.org

Principal Investigator

Arthur Winer, MD

PRINCIPAL_INVESTIGATOR

Inova Health Care Service

Study Locations (Sites)

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Inova Health Care Service

Falls Church, Virginia, 22042

United States

Collaborators and Investigators

Sponsor: Inova Health Care Services

Arthur Winer, MD, PRINCIPAL_INVESTIGATOR, Inova Health Care Service

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-31

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-07-31

Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

Hepatocellular Carcinoma
Cirrhosis