Trials / Completed
CompletedNCT00134043
Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer
Phase II Study of Histone Deacetylase Inhibitor SAHA (Vorinostat) in Patients With Metastatic Thyroid Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Insular Thyroid Cancer
- Recurrent Thyroid Cancer
- Stage II Follicular Thyroid Cancer
- Stage II Papillary Thyroid Cancer
- Stage IV Follicular Thyroid Cancer
- Stage IV Papillary Thyroid Cancer
- Thyroid Gland Medullary Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | vorinostat | Given orally |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2005-08-24
- Last updated
- 2014-08-11
- Results posted
- 2014-08-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00134043. Inclusion in this directory is not an endorsement.