xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06007846</url>
    </required_header>
    <id_info>
      <org_study_id>U23-01-4957</org_study_id>
      <nct_id>NCT06007846</nct_id>
    </id_info>
    <brief_title>A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer</brief_title>
    <official_title>A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inova Health Care Services</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inova Health Care Services</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-site prospective study to describe efficacy endpoints of single agent&#xD;
        memantine in patients with unresectable, locally advanced, or metastatic HCC otherwise not&#xD;
        deemed candidates for intensive systemic therapy. In addition to the primary endpoint and&#xD;
        multiple secondary efficacy endpoints, we will describe changes in quality of life on&#xD;
        treatment over time.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patients Progression Free Survival at 6 months</measure>
      <time_frame>6 months from the start of treatment</time_frame>
      <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.</description>
    </primary_outcome>
    <other_outcome>
      <measure>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)</measure>
      <time_frame>2 years from the initial visit</time_frame>
      <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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC-HCC18) over treatment</measure>
      <time_frame>2 years from the initial visit</time_frame>
      <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.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <condition>Cirrhosis</condition>
    <arm_group>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Namenda</intervention_name>
      <description>Memantine 5 mg by mouth once daily, to be titrated up to 20 mg daily</description>
      <arm_group_label>Arm 1</arm_group_label>
      <other_name>Memantine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 or older.&#xD;
  &#xD;
            2. Patients have newly diagnosed and previously untreated, histologically or&#xD;
               radiologically confirmed hepatocellular carcinoma with at least one lesion that is&#xD;
               measurable by RECIST 1.1 criteria. A prior HCC lesion that was treated surgically or&#xD;
               by radiation is allowed as long as it was at least 2 years or more from the current&#xD;
               HCC diagnosis.&#xD;
  &#xD;
            3. Patient's cancer must be deemed locally advanced and unresectable as per the consensus&#xD;
               of the Inova Multidisciplinary Cancer Care Conference.&#xD;
  &#xD;
            4. Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a&#xD;
               candidate for aggressive systemic treatment.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group Performance Status of 0-2.&#xD;
  &#xD;
            6. Patients must have adequate blood counts and organ function.&#xD;
  &#xD;
            7. Memantine is harmful to the human fetus. For this reason, sexually active males with&#xD;
               partners of childbearing potential must agree to use an accepted and effective method&#xD;
               of contraception prior to study entry and for the duration of the study. Women of&#xD;
               child bearing potential must have a negative serum pregnancy test result within 24&#xD;
               hours prior to initiation of study treatment. They must also agree to use agree to use&#xD;
               an accepted and effective method of contraception prior to study entry and for the&#xD;
               duration of the study.&#xD;
  &#xD;
            8. Patients must demonstrate ability to understand and the willingness to sign a written&#xD;
               informed consent document.&#xD;
  &#xD;
            9. Men and women, regardless of race, ethnic group or sexual orientation are eligible for&#xD;
               this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with Child-Pugh A cirrhosis.&#xD;
  &#xD;
            2. Female patients who are pregnant or breast-feeding.&#xD;
  &#xD;
            3. Concomitant illness or history that would prevent adequate patient assessment or in&#xD;
               the investigators' opinion pose an added risk for study participants.&#xD;
  &#xD;
            4. Life-threatening intercurrent illness.&#xD;
  &#xD;
            5. Anticipated poor compliance.&#xD;
  &#xD;
            6. Subject is enrolled in a separate interventional clinical trial.&#xD;
  &#xD;
            7. Active tuberculosis.&#xD;
  &#xD;
            8. Significant cardiovascular disease (such as New York Heart Association Class II or&#xD;
               greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3&#xD;
               months prior to initiation of study treatment, unstable arrhythmia, or unstable&#xD;
               angina.&#xD;
  &#xD;
            9. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.&#xD;
  &#xD;
           10. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a&#xD;
               stable regimen at study entry for at least 10 days prior to study entry.&#xD;
  &#xD;
           11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days&#xD;
               prior to initiation of study treatment.&#xD;
  &#xD;
           12. Symptomatic, untreated, or actively progressing central nervous system (CNS)&#xD;
               metastases.&#xD;
  &#xD;
           13. Patients undergoing other anti-cancer treatment. Palliative radiation for symptom&#xD;
               control will be allowed while on protocol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Arthur Winer, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Inova Health Care Service</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elahe Mollapour</last_name>
      <phone>571-472-0615</phone>
      <email>elahe.mollapour@inova.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Keary Jane't</last_name>
      <phone>571-472-0234</phone>
      <email>keary.janet@inova.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Inova Health Care Service</name>
        <address>
          <city>Falls Church</city>
          <state>Virginia</state>
          <zip>22042</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Elahe Mollapour</last_name>
        <phone>571-472-0615</phone>
        <email>elahe.mollapour@inova.org</email>
      </contact>
      <contact_backup>
        <last_name>Keary Jane't</last_name>
        <phone>571-472-3173</phone>
        <email>keary.janet@inova.org</email>
      </contact_backup>
      <investigator>
        <last_name>Arthur Winer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
      <mesh_term>Liver Cirrhosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Memantine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06007846
  org study id: U23-01-4957
  nct id: NCT06007846
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Patients Progression Free Survival at 6 months
  time frame: 6 months from the start of treatment
  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.
  measure: 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)
  time frame: 2 years from the initial visit
  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.
  measure: Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC-HCC18) over treatment
  time frame: 2 years from the initial visit
  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.
  arm group label: Arm 1
  arm group type: Experimental
  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
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Arthur Winer, MD
  role: Principal Investigator
  affiliation: Inova Health Care Service
  last name: Elahe Mollapour
  phone: 571-472-0615
  email: elahe.mollapour@inova.org
  last name: Keary Jane't
  phone: 571-472-0234
  email: keary.janet@inova.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
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  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Liver Cirrhosis
  mesh term: Fibrosis
  mesh term: Memantine
  sharing ipd: No