Clinical trial NCT03253289 (phase 1, status: suspended)
Conditions: carcinoma, hepatocellular
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: meclizine oral tablet
SMILES: CC1=CC(CN2CCN(CC2)C(C2=CC=CC=C2)C2=CC=C(Cl)C=C2)=CC=C1
Reason stopped: 
    this study has been temporarily suspended to accrual by the data review committee due to a
    protocol violation that recently occurred. the study will resume to accrual after the protocol
    has been amended and approved by the irb and drc.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have imaging (MRI or CT abdomen liver protocol) confirmed or highly
             suspicious for Hepatocellular carcinoma.

          2. 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.

          3. Patients must have no prior history of treatment for HCC (treatment naïve) on the
             lesion that is being targeted for biopsy New HCC lesions can arise in the liver of
             patients despite local therapy of other areas of the liver due to consistent
             underlying risk factors such as cirrhosis, and chronic hepatitis B or C infection.
             Patients with prior local liver directed therapy such as TACE, Ablation, Y-90 or
             hepatectomy surgery for HCC are eligible if they have developed a new untreated lesion
             in the liver which can be targeted for a biopsy. Patients who have had prior systemic
             therapy of any kind are not eligible.

          4. Patients must be greater than 18 years of age.

          5. ECOG Performance status less than/equal to 2 (Karnofsky greater than 60%).

          6. Patients must have normal organ and marrow function as defined below, within 21 days
             of registration: Leukocytes greater than 3,000/mcL; ANC greater than 1,500/mcL;
             Platelets greater than 50,000/mcL; Hemoglobin greater than/equal to 8 g/dL; ALT(SGPT)
             less than/equal to 5X IULN and AST (SGOT) less than/equal to 5X IULN; Creatinine less
             than/equal to 2X IULN or Creatinine clearance greater than 60 mL/min for patients with
             creatinine levels greater than IULN; Child Pugh Class A (5-6 points) or B (7 points);
             INR less than/equal to 2.3; Albumin greater than 2.8 g/dL; Total bilirubin less
             than/equal to 3X IULN.

          7. Patients must be candidate for surgical resection, ablation, TACE, Y90 or systemic
             therapy.

          8. Patients should have life expectancy greater than/equal to 10 weeks.

          9. 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.

         10. Patients 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.

        Exclusion Criteria:

          1. Patients may not be receiving any other concurrent anti-cancer therapy.

          2. Patients may not be receiving any other concurrent investigational agents.

          3. Patients taking medications with a narrow therapeutic index including warfarin,
             digoxin, phenobarbital, carbamazepine, and cyclosporine are not excluded but should be
             monitored carefully.

          4. Patients must not be taking Rifampin or St John's Wort.

          5. 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.

          6. Patient must not be a candidate for liver transplant.

          7. Child Pugh Class B (8,9) and Class C are excluded

          8. Antiviral therapy for HCV and HBV is allowed, but patient should not be on interferon.

          9. HIV-positive patients on combination antiretroviral therapy are ineligible because of
             the potential for pharmacokinetic interactions with meclizine.

         10. 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.

         11. Pregnant women are excluded from this study because meclizine is a 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.