Recurrent Thyroid Cancer Clinical Trial
Official title:
Phase II Study of Histone Deacetylase Inhibitor SAHA (Vorinostat) in Patients With Metastatic Thyroid Carcinoma
This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with metastatic and/or locally advanced or locally recurrent thyroid cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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