Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134043
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2005-08-22
Brief Title:
Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic andor Locally Advanced or Locally Recurrent Thyroid Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Histone Deacetylase Inhibitor SAHA Vorinostat in Patients With Metastatic Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with metastatic andor 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 andor 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
I Determine the objective response rate in patients with metastatic andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04110 | None | None | None |
| CDR0000439450 | None | None | None |
| NCI-6902 | None | None | None |
| N01CM62207 | NIH | None | httpsreporternihgovquickSearchN01CM62207 |
| OSU-04110 | None | None | None |