Clinical Trial: Belinostat (PXD101) to Treat Tumors of the Thymus at an Advanced Stage
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter Phase II Study of Belinostat (PXD-101) in Previously Chemotherapy Treated Thymoma and Thymic Carcinoma
Brief 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
