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

Primary Purpose

Hepatocellular Carcinoma, Cirrhosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Namenda
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 or older. 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. Patient's cancer must be deemed locally advanced and unresectable as per the consensus of the Inova Multidisciplinary Cancer Care Conference. Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a candidate for aggressive systemic treatment. Eastern Cooperative Oncology Group Performance Status of 0-2. Patients must have adequate blood counts and organ function. 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. Patients must demonstrate ability to understand and the willingness to sign a written informed consent document. Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study. Exclusion Criteria: Patients with Child-Pugh A cirrhosis. Female patients who are pregnant or breast-feeding. Concomitant illness or history that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants. Life-threatening intercurrent illness. Anticipated poor compliance. Subject is enrolled in a separate interventional clinical trial. Active tuberculosis. 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. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 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. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Patients undergoing other anti-cancer treatment. Palliative radiation for symptom control will be allowed while on protocol.

Sites / Locations

  • Inova Schar Cancer InstituteRecruiting
  • Inova Health Care Service

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Patients Progression Free Survival at 6 months
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.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2023
Last Updated
September 19, 2023
Sponsor
Inova Health Care Services
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1. Study Identification

Unique Protocol Identification Number
NCT06007846
Brief Title
A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
Official Title
A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Namenda
Other Intervention Name(s)
Memantine
Intervention Description
Memantine 5 mg by mouth once daily, to be titrated up to 20 mg daily
Primary Outcome Measure Information:
Title
Patients Progression Free Survival at 6 months
Description
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.
Time Frame
6 months from the start of treatment
Other Pre-specified Outcome Measures:
Title
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)
Description
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.
Time Frame
2 years from the initial visit
Title
Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC-HCC18) over treatment
Description
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.
Time Frame
2 years from the initial visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older. 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. Patient's cancer must be deemed locally advanced and unresectable as per the consensus of the Inova Multidisciplinary Cancer Care Conference. Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a candidate for aggressive systemic treatment. Eastern Cooperative Oncology Group Performance Status of 0-2. Patients must have adequate blood counts and organ function. 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. Patients must demonstrate ability to understand and the willingness to sign a written informed consent document. Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study. Exclusion Criteria: Patients with Child-Pugh A cirrhosis. Female patients who are pregnant or breast-feeding. Concomitant illness or history that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants. Life-threatening intercurrent illness. Anticipated poor compliance. Subject is enrolled in a separate interventional clinical trial. Active tuberculosis. 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. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 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. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Patients undergoing other anti-cancer treatment. Palliative radiation for symptom control will be allowed while on protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elahe Mollapour
Phone
571-472-0615
Email
elahe.mollapour@inova.org
First Name & Middle Initial & Last Name or Official Title & Degree
Keary Jane't
Phone
571-472-0234
Email
keary.janet@inova.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Winer, MD
Organizational Affiliation
Inova Health Care Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elahe Mollapour
First Name & Middle Initial & Last Name & Degree
Keary Jane't
First Name & Middle Initial & Last Name & Degree
Arthur Winer, MD
Facility Name
Inova Health Care Service
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elahe Mollapour
Phone
571-472-0615
Email
elahe.mollapour@inova.org
First Name & Middle Initial & Last Name & Degree
Keary Jane't
Phone
571-472-3173
Email
keary.janet@inova.org
First Name & Middle Initial & Last Name & Degree
Arthur Winer

12. IPD Sharing Statement

Plan to Share IPD
No
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A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer

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