Belinostat (PXD101) to Treat Tumors of the Thymus at an Advanced Stage

Summary

Background: * Cisplatin-containing chemotherapy is the standard treatment for advanced tumors of the thymus that cannot be removed surgically. * New treatment options are needed for patients with advanced tumors of the thymus that do not improve with cisplatin-containing therapy. * Belinostat is a drug that inhibits enzymes called histone deacetylase. Histone deacetylase inhibitors have shown promising activity in many cancers and may be useful in treating patients with thymic tumors. Objectives: -To assess the safety and effectiveness of belinostat for treatment of malignant thymic tumors in patients who failed after standard treatment. Eligibility: -Patients 18 years of age or older with an advanced thymic tumor that has progressed after treatment with platinum-containing chemotherapy. Design: * Patients receive belinostat treatment in 21-day cycles. The drug is given as an infusion through a vein during days 1 through 5 of each cycle. Treatment cycles continue as long as the medicine is tolerated and the cancer does not worsen. * Patients have a physical examination and several blood tests during every cycle. * Patients have an electrocardiogram every cycle before starting the belinostat infusion and again on the last day of the infusion. * Patients undergo computed tomography (CT) or other imaging test, such as ultrasound or MRI, every two cycles to evaluate the response of the tumor to treatment. * Tumor tissue obtained from a previous biopsy is used for research purposes.

Timeline

Start

2007-12

Primary completion

2013-07

Completion

2014-06

Publications

• Background Giaccone G, Wilmink H, Paul MA, van der Valk P. Systemic treatment of malignant thymoma: a decade experience at a single institution. Am J Clin Oncol. 2006 Aug;29(4):336-44. doi: 10.1097/01.coc.0000227481.36109.e7.
• Background Wright CD. Management of thymomas. Crit Rev Oncol Hematol. 2008 Feb;65(2):109-20. doi: 10.1016/j.critrevonc.2007.04.005. Epub 2007 Jun 14.
• Background Giaccone G. Treatment of malignant thymoma. Curr Opin Oncol. 2005 Mar;17(2):140-6. doi: 10.1097/01.cco.0000152628.43867.8e.
• Results Giaccone G, Rajan A, Berman A, Kelly RJ, Szabo E, Lopez-Chavez A, Trepel J, Lee MJ, Cao L, Espinoza-Delgado I, Spittler J, Loehrer PJ Sr. Phase II study of belinostat in patients with recurrent or refractory advanced thymic epithelial tumors. J Clin Oncol. 2011 May 20;29(15):2052-9. doi: 10.1200/JCO.2010.32.4467. Epub 2011 Apr 18.

Drugs

Indications