Status:
TERMINATED
Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
Johns Hopkins University
Stanford University
Conditions:
Vestibular Schwannoma
Meningioma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This will be a multi-center, proof of concept phase 0 study to assess the suppression of p-AKT in Vestibular Schwannoma (VS) and meningiomas by AR-42 in adult patients undergoing tumor resection. AR-4...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02282917
Start Date
December 1 2015
End Date
January 4 2021
Last Update
December 5 2025
Active Locations (4)
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1
Stanford University
Stanford, California, United States, 94305
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02214
4
Mayo Clinic
Rochester, Minnesota, United States, 55905