A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInova Health Care Services
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Namenda
DrugMemantine 5 mg by mouth once daily, to be titrated up to 20 mg daily
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Arm 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months from the start of treatmentOther outcomes
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)
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 visit2
Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC-HCC18) over treatment
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 visitSponsors and contacts
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Source ClinicalTrials.gov