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

Sponsor
Inova Health Care Services (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06007846
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma
Anticipated Study Start Date :
Aug 31, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Drug: Namenda
Memantine 5 mg by mouth once daily, to be titrated up to 20 mg daily
Other Names:
  • Memantine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patients Progression Free Survival at 6 months [6 months from the start of treatment]

      The response and progression will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. The progression of the disease is defined as at least a 20% increase in the sum of the Longest Diameter LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions or death due to disease without objective evidence of progression.

    Other Outcome Measures

    1. Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire for cancer (EORTC QLQ-C30) [2 years from the initial visit]

      The EORTC QLQ-C30 consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each score is transformed onto a 0 to 100 point scale. For the symptom scales and single items, a higher score implies a high level of symptoms or problems. Previously published minimally important differences will be used to identify meaningful changes from baseline in each treatment group on the disease and treatment-related symptom scales.

    2. Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC-HCC18) over treatment [2 years from the initial visit]

      The EORTC QLQ-HCC18 is a disease-specific measure which contains five multi-item symptom scales (fatigue, body image, jaundice, nutrition, and fever), and four single-item measures (shoulder pain, abdominal pain, abdominal swelling, and sex life) for a total of 18 questions with a recall period of the previous week. The EORTC QLQ-HCC18 module takes approximately 5 minutes to complete. All item responses are scored according to the EORTC guidelines for scoring.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inova Health Care Service Falls Church Virginia United States 22042

    Sponsors and Collaborators

    • Inova Health Care Services

    Investigators

    • Principal Investigator: Arthur Winer, MD, Inova Health Care Service

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT06007846
    Other Study ID Numbers:
    • U23-01-4957
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Liver Cirrhosis
    Fibrosis
    Memantine

    Study Results

    No Results Posted as of Aug 23, 2023