Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278395
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2006-01-16
Brief Title:
Vorinostat in Treating Patients With Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Pharmacokinetic and Biologic Correlative Study of Suberoylanilide Hydroxamic Acid SAHA in Patients With Advanced Renal Cell Carcinoma RCC
Status:
COMPLETED
Status Verified Date:
2017-10
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 advanced kidney cancer Drugs used in chemotherapy such as vorinostat work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Vorinostat may also stop the growth of tumor cells by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor activity of vorinostat SAHA in terms of objective response and progression rate in patients with advanced renal cell carcinoma
SECONDARY OBJECTIVES
I Evaluate the safety and tolerability of this drug in terms of toxicity profile in these patients
II Evaluate overall survival progression-free survival and survival rate at 12 months in patients treated with this drug
III Correlate changes in biologic measurements with outcomes of patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive oral vorinostat SAHA twice daily on days 1-3 8-10 15-17 and 22-24 Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity Patients may have the option of continuing treatment beyond 52 weeks at the discretion of the investigator
After completion of study treatment patients are followed within 1 month and then approximately every 2 months thereafter
I Determine the antitumor activity of vorinostat SAHA in terms of objective response and progression rate in patients with advanced renal cell carcinoma
SECONDARY OBJECTIVES
I Evaluate the safety and tolerability of this drug in terms of toxicity profile in these patients
II Evaluate overall survival progression-free survival and survival rate at 12 months in patients treated with this drug
III Correlate changes in biologic measurements with outcomes of patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive oral vorinostat SAHA twice daily on days 1-3 8-10 15-17 and 22-24 Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity Patients may have the option of continuing treatment beyond 52 weeks at the discretion of the investigator
After completion of study treatment patients are followed within 1 month and then approximately every 2 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 |
|---|---|---|---|
| U01CA069853 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069853 |
| NCI-2009-00087 | REGISTRY | None | None |
| CDR0000456500 | OTHER | None | None |
| 04-10 | OTHER | None | None |
| 6825 | OTHER | None | None |