Trial of LBH589 in Metastatic Thyroid Cancer
The purpose of this study is to evaluate the tumor response rate in patients with metastatic medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC) after receiving treatment with LBH589 20 mg by mouth, three times weekly. Time to progression, overall survival, toxicity, tolerability, and Notch1 protein expression patterns will also be evaluated.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of LBH589 in Patients With Metastatic Medullary Thyroid Cancer and Radioactive Iodine Resistant Differentiated Thyroid Cancer|
- Tumor response rate to LBH589. [ Time Frame: Every 8 weeks. ] [ Designated as safety issue: No ]
- Protein expression patterns of Notch1 in thyroid tissue samples. [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Time to progression of thyroid cancer [ Time Frame: Yearly ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Yearly ] [ Designated as safety issue: No ]
- Impact of LBH589 on tumor markers for thyroid cancer [ Time Frame: Yearly ] [ Designated as safety issue: No ]
- Toxicity of LBH589 [ Time Frame: Every 4 weeks. ] [ Designated as safety issue: Yes ]
- Tolerability of LBH589 [ Time Frame: Every 4 weeks. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
Other Name: panobinostat
Medullary thyroid cancer (MTC) is a neuroendocrine tumor and accounts for 3-5% of cases of thyroid cancer. The majority of patients with MTC do not present with early stage disease. Differentiated thyroid cancer (DTC) accounts for >90% of all thyroid cancers. In a sub-set of patients, thyroid cells become resistant to I-131 radioiodine therapy and subsequently develop distant metastases. In both MTC and DTC, systemic chemotherapy for metastatic disease is largely ineffective.
LBH589 is a histone deacetylase (HDAC) with recently demonstrated activity to inhibit the Notch1 signaling pathway in MTC cancer cells and suppress tumor cell proliferation in DTC cancer cells. This clinical trial will evaluate the tumor response rate of LBH589 in patients with metastatic MTC or radioactive iodine resistant DTC.
|United States, Wisconsin|
|St. Vincent Regional Cancer Center CCOP|
|Green Bay, Wisconsin, United States, 54301|
|University of Wisconsin - Madison|
|Madison, Wisconsin, United States, 53792|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Anne Traynor, M.D.||University of Wisconsin, Madison|