Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138203
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2005-08-29
Brief Title:
Suberoylanilide Hydroxamic Acid in Treating Patients With Stage IIIB Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Suberoylanilide Hydroxamic Acid SAHA in Patients With Relapsed Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2018-01
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 suberoylanilide hydroxamic acid works in treating patients with stage IIIB stage IV or recurrent non-small cell lung 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 To evaluate the response of non-small cell lung cancer to SAHA in the second line setting by applying RECIST criteria
SECONDARY OBJECTIVES
I To estimate the time to progression and overall survival in this patient population
II To examine the toxicity profile of SAHA
TERTIARY OBJECTIVES
I To evaluate the molecular activity of SAHA by evaluating its effect on histone acetylation upregulation of target genes generation of reactive oxygen species apoptosis and correlation with P53 status
II To explore gene expression profiles that predict response to SAHA
OUTLINE This is a multicenter study
Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 1 month and then every 3 months for 1 year or until disease progression
I To evaluate the response of non-small cell lung cancer to SAHA in the second line setting by applying RECIST criteria
SECONDARY OBJECTIVES
I To estimate the time to progression and overall survival in this patient population
II To examine the toxicity profile of SAHA
TERTIARY OBJECTIVES
I To evaluate the molecular activity of SAHA by evaluating its effect on histone acetylation upregulation of target genes generation of reactive oxygen species apoptosis and correlation with P53 status
II To explore gene expression profiles that predict response to SAHA
OUTLINE This is a multicenter study
Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 1 month and then every 3 months for 1 year or until disease progression
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-2012-03070 | REGISTRY | None | None |
| CO 04510 | OTHER | None | None |
| 6860 | OTHER | None | None |
| P30CA014520 | NIH | None | None |
| U01CA062491 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062491 |