Trial of LBH589 in Metastatic Thyroid Cancer

Inclusion Criteria:

• Histologically confirmed metastatic medullary or differentiated thyroid cancer. Diagnosis must be confirmed at University of Wisconsin
• Patients must have measurable disease as defined by RECIST.
• At least 3 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration
• No concurrent chemotherapy or radiation therapy
• ECOG Performance Status of ≤ 2
• Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
• Adequate bone marrow, kidney, liver function
• Left ventricular ejection fraction ≥ the lower limit of the institutional normal
• Those with differentiated thyroid cancer must have radioactive iodine resistant disease, defined by failure to incorporate 131-Iodine after therapy, FDG-avidity on a PET scan, or progression of measurable disease after 131-Iodine therapy or an allergy to radioactive iodine
• Hypertension must be well controlled (to less than 150/90 mmHg) on a stable regimen of anti-hypertensive therapy

Exclusion Criteria:

• Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
• Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment
• Impaired cardiac function
• Concomitant use of drugs with a risk of causing torsades de pointes
• Patients with unresolved diarrhea > CTCAE grade 1
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
• Other concurrent severe and/or uncontrolled medical conditions
• Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and 3 months after last study drug administration. Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of oral LBH589.
• Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment
• Patients with a history of another primary malignancy that, in the opinion of the investigator, would interfere with the assessment of the primary endpoints of the study
• Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C
• Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent