Belinostat (PXD101) to Treat Tumors of the Thymus at an Advanced Stage
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
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.