Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-01-06 @ 11:45 AM
Study NCT ID:
NCT00278395
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2006-01-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vorinostat in Treating Patients With Kidney Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: