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

Study 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.

Primary Outcome

Response is defined by the Response Evaluation Criteria in Solid Tumor (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. For additional details about the RECIST criteria see the protocol Link module.

Interventions

• DRUG Belinostat (PDX101)