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A phase I/II trial of the histone deacetylase inhibitor, romidepsin, for adults with recurrent malignant glioma: North American Brain Tumor Consortium Study 03-03.


Posted on: 03/09/2011

Neuro Oncol. 2011 Mar 3. [Epub ahead of print]
 

A phase I/II trial of the histone deacetylase inhibitor, romidepsin, for adults with recurrent malignant glioma: North American Brain Tumor Consortium Study 03-03.

 

Iwamoto FM, Lamborn KR, Kuhn JG, Wen PY, Alfred Yung WK, Gilbert MR, Chang SM, Lieberman FS, Prados MD, Fine HA.
Neuro-Oncology Branch, National Cancer Institute, National Institute of Neurological Disorder and Stroke, National Institutes of Health, Bethesda, Maryland (F.M.I., H.A.F.); Department of Neurological Surgery, University of California-San Francisco, California (K.R.L., S.M.C., M.D.P.); University of Texas Health Science Center at San Antonio (J.G.K.), and the Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (W.K.A.Y., M.R.G); Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts (P.Y.W.); Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (F.S.L.).
 
Abstract
Romidepsin, a potent histone deacetylase inhibitor, has shown activity in preclinical glioma models. The primary objectives of this trial were to determine the pharmacokinetics of romidepsin in patients with recurrent glioma on enzyme-inducing antiepileptic drugs (EIAEDs) and to evaluate the antitumor efficacy of romidepsin in patients with recurrent glioblastoma who were not receiving EIAEDs. Two dose cohorts were studied in the phase I component of the trial (13.3 and 17.7 mg/m(2)/d). Patients in the phase II component were treated with intravenous romidepsin at a dosage of 13.3 mg/m(2)/day on days 1, 8, and 15 of each 28-day cycle. Eight patients were treated on the phase I component. A similar romidepsin pharmacokinetic profile was demonstrated between patients receiving EIAEDs to those not receving EIAEDs. Thirty-five patients with glioblastoma were accrued to the phase II component. There was no objective radiographic response. The median progression-free survival (PFS) was 8 weeks and only 1 patient had a PFS time ≥6 months (PFS6 = 3%). To date, 34 patients (97%) have died, with a median survival duration of 34 weeks. Despite in vitro studies showing that romidepsin is primarily metabolized by CYP3A4, no decrease in exposure to romidepsin was seen in patients receiving potent CYP3A4 inducers. Romidepsin, at its standard dose and schedule, was ineffective for patients with recurrent glioblastomas. ClinicalTrials.gov identifier: NCT00085540.
 
 PMID: 21377994 [PubMed - as supplied by publisher] 
 

 


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