Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma

Inclusion Criteria:

   - Patients with vestibular schwannoma and/or meningioma diagnosed by MRI where surgical
   resection has been selected as treatment.

   - Patients diagnosed with NF2 must meet Manchester Criteria.

   - Age > 18 years of age

   - Prior biologic therapy, chemotherapy, surgery or radiation is permitted.

   - At the time of screening, the patient must have normal organ and marrow function.

   - Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance
   status of 0-1.

   - Patients must be able to swallow capsules.

   - Patients or their legal representatives must be able to read, understand and provide
   informed consent to participate in the trial.

   - Tumor type will be confirmed by a neuropathologist.

   - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
   test with a sensitivity of at least 50 mIU/mL prior to starting AR-42.

   - The patient must be willing to comply with fertility requirements

Exclusion Criteria:

   - Pregnant women are excluded from this study because the potential for teratogenic or
   abortifacient effects of AR-42 are not known. Because there is an unknown but
   potential risk for AEs in nursing infants secondary to treatment of the mother with
   AR-42, breastfeeding should be discontinued if the mother is treated with AR-42.

   - Pediatric patients are excluded from the phase 0 study as the effects of AR-42 are not
   known on children and there is no potential direct benefit to them.

   - Patients with malabsorption or any other condition that in the opinion of the
   principal investigator could cause difficulty in absorption of drug.

   - Patients requiring chronic corticosteroids (dose equivalent > 20mg prednisolone).

   - Concurrent use of complementary or alternative medicines that in the opinion of the
   principal investigator would confound the interpretation of toxicities and/or
   antitumor activity of the study drug.

   - Patients with a "currently active" second malignancy that, in the opinion of the
   principal investigator, will interfere with patient participation, increase patient
   risk, or confound data interpretation.

   - Patients with a mean QTcB > 450 msec in males and > 470 msec in females.

   - Patients with long QT syndrome.

   - Patients who are being treated for an active infection.

   - Patients receiving the following concomitant medications:

      - Any other anti-neoplastic chemotherapy or biologic therapy during the study

      - Concomitant radiotherapy

      - Concomitant HDAC inhibitors (e.g. valproic acid) as class-specific adverse
      reactions may be additive

      - Use of granulocyte colony-stimulating factors including G-CSF, pegylated G-CSF or
      GM-CSF should follow ASCO guidelines for patients receiving anti-cancer therapy.

      - Drugs associated with QT/QTc prolongation (see Appendix A)

   - Patients who are receiving concurrent anti-neoplastic therapy.

   - Any other medical condition, including mental illness or substance abuse, deemed by
   the principal investigator to likely interfere with a patient's ability to sign
   informed consent, cooperate and participate in the study, or interfere with the
   interpretation of the results.

   - Patients with significant cardiovascular disease, including a myocardial infarction or
   unstable angina within 6 months or unstable cardiac arrhythmias are not eligible for
   the study.

   - Known HIV infection, as their immunosuppressive conditions may complicate potential
   pancytopenias seen with HDAC inhibitors and complicate evaluation of drug effect.