Marizomib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial, and Spinal Cord Ependymoma

Summary

Background: Ependymomas are rare tumors that arise from the ependyma. That is a tissue of the central nervous system. They can develop in the brain or the spine. They are usually treated with surgery, radiation, and/or chemotherapy. Researchers want to see if the new drug marizomib can help people with a certain kind of ependymoma. Objective: To see if marizomib stops tumor growth and prolongs the time that the tumor is controlled. Eligibility: Adults age 18 and older who have been diagnosed with ependymomas and have already been treated with standard therapies Design: Participants will be screened with the following tests or recent results from similar tests: * Medical history * Physical exam * Neurological assessment * Electrocardiogram (EKG) to evaluate the heart * Review of symptoms and ability to perform normal activities * Computed tomographic scan (CT) or magnetic resonance imaging (MRI) to produce an image of the brain or spine. * Blood and urine tests * Tests of tumor samples. Participants may have to have new tumor samples taken. Participants will get the study drug in cycles. Each cycle is 4 weeks. Participants will have up to 24 cycles. Participants will get the study drug through a small plastic tube in a vein on days 1, 8, and 15 of each cycle. During each cycle, some screening tests will be repeated. Participants will answer questions about their general well-being and functioning. About 4 5 weeks after finishing the study drug, participants will have a follow-up visit. They will answer questions about their health, get a physical and a neurological exam, and have blood tests. They may have an MRI or CT scan. ...

Timeline

Start

2020-01-22

Primary completion

2021-04-30

Completion

2021-04-30

Publications

• Background Wu J, Armstrong TS, Gilbert MR. Biology and management of ependymomas. Neuro Oncol. 2016 Jul;18(7):902-13. doi: 10.1093/neuonc/now016. Epub 2016 Mar 28.
• Background Harrison SJ, Mainwaring P, Price T, Millward MJ, Padrik P, Underhill CR, Cannell PK, Reich SD, Trikha M, Spencer A. Phase I Clinical Trial of Marizomib (NPI-0052) in Patients with Advanced Malignancies Including Multiple Myeloma: Study NPI-0052-102 Final Results. Clin Cancer Res. 2016 Sep 15;22(18):4559-66. doi: 10.1158/1078-0432.CCR-15-2616. Epub 2016 Apr 26.
• Background Di K, Lloyd GK, Abraham V, MacLaren A, Burrows FJ, Desjardins A, Trikha M, Bota DA. Marizomib activity as a single agent in malignant gliomas: ability to cross the blood-brain barrier. Neuro Oncol. 2016 Jun;18(6):840-8. doi: 10.1093/neuonc/nov299. Epub 2015 Dec 17.

Drugs

Indications