Phase II Study of Histone Deacetylase Inhibitor SAHA (Vorinostat) in Patients With Metastatic Thyroid Carcinoma
I. Determine the objective response rate in patients with metastatic and/or locally advanced
or locally recurrent thyroid cancer treated with suberoylanilide hydroxamic acid.
I. Determine the toxicity of this drug in these patients.
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.
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
Ohio State University
United States: Food and Drug Administration
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