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Trial Title:
A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
NCT ID:
NCT06007846
Condition:
Hepatocellular Carcinoma
Cirrhosis
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Cirrhosis
Fibrosis
Memantine
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Namenda
Description:
Memantine 5 mg by mouth once daily, to be titrated up to 20 mg daily
Arm group label:
Arm 1
Other name:
Memantine
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elahe Mollapour
Contact backup:
Last name:
Keary Jane't
Investigator:
Last name:
Arthur Winer, MD
Email:
Principal Investigator
Facility:
Name:
Inova Health Care Service
Address:
City:
Falls Church
Zip:
22042
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Elahe Mollapour
Phone:
571-472-0615
Email:
elahe.mollapour@inova.org
Contact backup:
Last name:
Keary Jane't
Phone:
571-472-3173
Email:
keary.janet@inova.org
Investigator:
Last name:
Arthur Winer
Email:
Principal Investigator
Start date:
July 31, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Inova Health Care Services
Agency class:
Other
Source:
Inova Health Care Services
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06007846
