Phase II Study of Histone Deacetylase Inhibitor SAHA (Vorinostat) in Patients With Metastatic Thyroid Carcinoma
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with metastatic and/or locally advanced
or locally recurrent thyroid cancer treated with suberoylanilide hydroxamic acid.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this drug in these patients.
OUTLINE:
Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving
a complete response receive an additional 2 courses of SAHA. Patients achieving stable
disease or a partial response receive 4 additional courses of SAHA. After completion of
study treatment, patients are followed within 4 weeks.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (PR + CR) using RECIST/WHO response criteria
Up to 3 years
No
Manisha Shah
Principal Investigator
Ohio State University
United States: Food and Drug Administration
NCI-2012-01468
NCT00134043
December 2005
Name | Location |
---|---|
Ohio State University Medical Center | Columbus, Ohio 43210 |