Phase II trial of the histone deacetylase inhibitor romidepsin in patients with recurrent/metastatic head and neck cancer.

ABSTRACT:

Objectives

Patients with advanced squamous cell carcinoma of the head and neck (SCCHN) have limited treatment options. Inhibition of histone deacetylases (HDACs) represents a novel therapeutic approach warranting additional investigation in solid tumors.

Methods

A phase II trial of single agent romidepsin, an HDAC inhibitor, was performed in 14 patients with SCCHN who provided consent for pre- and post-therapy samples of accessible tumor, blood and uninvolved oral mucosa. Romidepsin was administered at 13 mg/m(2) as a 4-h intravenous infusion on days 1, 8 and 15 of 28 day cycles, with response assessment by RECIST every 8 weeks.

Results

Objective responses were not observed, although 2 heavily pretreated patients had brief clinical disease stabilization. Observed toxi

SUBMITTER: Haigentz M 

PROVIDER: S-EPMC3465519 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature