Exploratory Evaluation of AR-42 for Vestibular Schwannoma and Meningioma

Title

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

MEEI Protocol ID

14-078H

National Clinical Trial (NCT) Number

02282917

Condition

Vestibular Schwannoma, Meningioma, Acoustic Neuroma, Neurofibromatosis Type 2

Sponsor

Department of Defense

Principal Investigator

Brad Welling, M.D., Ph.D., FACS

Study Design

Proof of concept, Phase 0

Study Objective

Assess the suppression of p-AKT in Vestibular Schwannoma (VS) and meningiomas by AR-42 in adult patients undergoing NF2-tumor resection

Who is Eligible

  • 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.
  • 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

Subject Enrollment

20

Study Procedures

This is a multi-center, proof of concept phase 0 study to assess the suppression of p-AKT in VS and meningiomas by AR-42 in adult patients undergoing NF2-tumor resection. AR-42 will be administered three times per week beginning 3 weeks prior to surgery. A total of ten doses, + 1 dose at 40 mg/dose, will be self-administered orally by study participants at approximately the same time every day (+ 1 hour, preferably in the evening) 3 times per week for 3 weeks pre-operatively, with the last dose taken the night before surgery. Patients will be evaluated within the context of their standard post-operative follow up which includes within 2 days of surgery and again at 2 weeks (+/- 10 days) after surgery. Samples will be shipped to the participating laboratories (OSU Comprehensive Cancer Center (CCC) Pharmacoanalytical Shared Resource (PhASR) and Nationwide Children's Research Institute) for assessment of intratumoral drug concentration and assessment of intratumoral disease markers. During surgery, four blood samples will also be obtained and sent to the cooperating laboratory (PhASR) for determination of drug concentration and molecular analysis.

For More Information

Sybil_Murphy@meei.harvard.edu; 617-573-4192



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