Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121225
Status:
COMPLETED
Last Update Posted:
2019-01-29
First Post:
2005-07-19
Brief Title:
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Vorinostat in Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2019-01
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 metastatic or unresectable melanoma Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVE
I Determine the objective response rate in patients with metastatic or unresectable melanoma treated with vorinostat
SECONDARY OBJECTIVES
I Determine time to progression in patients treated with this drug II Determine the utility of HP1 andor macro H2A nuclear foci as biomarkers of response in patients treated with this drug
III Correlate the presence of 72R or 72P variant p53 polymorphisms with response and time to progression in patients treated with this drug
IV Determine gene expression profiles that may predict response to this drug and gene expression changes that occur after treatment with this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral vorinostat once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks and then every 3 months thereafter
I Determine the objective response rate in patients with metastatic or unresectable melanoma treated with vorinostat
SECONDARY OBJECTIVES
I Determine time to progression in patients treated with this drug II Determine the utility of HP1 andor macro H2A nuclear foci as biomarkers of response in patients treated with this drug
III Correlate the presence of 72R or 72P variant p53 polymorphisms with response and time to progression in patients treated with this drug
IV Determine gene expression profiles that may predict response to this drug and gene expression changes that occur after treatment with this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral vorinostat once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks and then every 3 months thereafter
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 |
|---|---|---|---|
| PHL-040 | OTHER_GRANT | None | None |
| CDR0000436851 | OTHER_GRANT | None | None |
| N01CM62203 | NIH | N01CM62203 | httpsreporternihgovquickSearchN01CM62203 |