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
Qualifiers
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
Treatments tested in this trial
- Namenda
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov