Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132028
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-08-16
Brief Title:
Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Suberoylanilide Hydroxamic Acid NSC-701852 for Recurrent or Primary Refractory Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 vorinostat works in treating patients with relapsed or refractory advanced Hodgkins lymphoma Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the response probability complete complete unconfirmed and partial in patients with relapsed or refractory Hodgkins lymphoma
II To estimate 1-year progression-free survival and overall survival in patients with relapsed or refractory Hodgkins lymphoma treated with SAHA
III To assess the toxicity profile of SAHA in this patient population IV To perform gene expression profiling on tumor tissue before and after treatment in order to explore in a preliminary manner the association between response and specific gene expression results
OUTLINE This is a multicenter study
Patients receive oral vorinostat twice daily on days 1-14 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses of therapy beyond CR
After completion of study treatment patients are followed every 6 months for 2 years and then annually for 3 years
I To evaluate the response probability complete complete unconfirmed and partial in patients with relapsed or refractory Hodgkins lymphoma
II To estimate 1-year progression-free survival and overall survival in patients with relapsed or refractory Hodgkins lymphoma treated with SAHA
III To assess the toxicity profile of SAHA in this patient population IV To perform gene expression profiling on tumor tissue before and after treatment in order to explore in a preliminary manner the association between response and specific gene expression results
OUTLINE This is a multicenter study
Patients receive oral vorinostat twice daily on days 1-14 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses of therapy beyond CR
After completion of study treatment patients are followed every 6 months for 2 years and then annually for 3 years
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 |
|---|---|---|---|
| NCI-2012-03071 | REGISTRY | None | None |
| U10CA032102 | NIH | None | None |
| S0517 | OTHER | None | None |
| S0517 | OTHER | CTEP | httpsreporternihgovquickSearchU10CA032102 |