Clinical Trial Details
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NCT02282917 : Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma
PhaseEarly Phase 1
AgesMin: 18 Years Max: N/A
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.
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