Meclizine in Treating Participants with Liver Carcinoma

Inclusion Criteria

• Patients must have imaging (magnetic resonance imaging [MRI] or computed tomography [CT] abdomen liver protocol) confirmed hepatocellular carcinoma. Patients cannot have metastatic HCC
• Patients must have measurable disease, defined as tumor mass which is > 10 mm with spiral CT scan or MRI. Baseline imaging scan must be within 8 weeks of registration.
• Patients must have no prior history of treatment for HCC (treatment naive).
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky > 60%).
• Obtained within 21 days of registration: leukocytes > 3,000/mcL
• Obtained within 21 days of registration: absolute neutrophil count (ANC) > 1,500/mcL
• Obtained within 21 days of registration: platelets > 50,000/mcL
• Obtained with 21 days of registration: hemoglobin >= 8 g/dL
• Obtained with 21 days of registration: alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional upper limit of normal
• Obtained with 21 days of registration: aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 5 x institutional upper limit of normal
• Obtained with 21 days of registration: creatinine =< 2 x institutional upper limit of normal OR creatinine clearance > 60 mL/min for patients with creatinine levels greater than institutional upper limit of normal
• Obtained with 21 days of registration: Child Pugh class A (5-6 points) or B (7 points)
• Obtained with 21 days of registration: international normalized ratio =< 2.3
• Obtained with 21 days of registration: albumin: > 2.8 g/dl
• Obtained with 21 days of registration: total bilirubin =< 3 x the upper limit of normal (ULN)
• Patients must be candidate for surgical resection, ablation, and transarterial chemoembolization (TACE).
• Patients should have life expectancy >= 10 weeks.
• Willingness to Use Contraception: The effects of Meclizine on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment with meclizine. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. If a male participant impregnates his partner he should inform his treating physician immediately.
• Subjects must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and federal guidelines.
• Patients may not be receiving any other anti-cancer therapy.
• Patients may not be receiving any other investigational agents.
• Patients taking medications with a narrow therapeutic index including warfarin, digoxin, phenobarbital, carbamazepine, and cyclosporine are not excluded but should be monitored carefully.
• Patient must not be taking Rifampin or St John`s wort.
• Patient must not have a history of allergic reactions like anaphylaxis attributed to compounds of similar chemical or biologic composition to meclizine such as antihistamine drugs.
• Patient must not be a candidate for liver transplant.
• Child Pugh class B (8,9) and class C are excluded.
• Antiviral therapy for hepatitis C virus (HCV) and hepatitis B virus (HBV) is allowed, but patient should not be on interferon.
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with meclizine.
• Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction or cerebrovascular accident within 6 months prior to registration, cardiac arrhythmia, glaucoma, asthma or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because meclizine is class B agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with meclizine, breastfeeding should be discontinued if the mother is treated with meclizine.