A Multicenter Phase II Study of Belinostat (PXD-101) in Previously Chemotherapy Treated Thymoma and Thymic Carcinoma

Detailed 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.

Study Details

Timeline

Interventions