Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324480
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2006-05-10
Brief Title:
Vorinostat and Alvocidib in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Suberoylanilide Hydroxamic Acid SAHA in Combination With Flavopiridol in Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-10
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 I trial is studying the side effects and best dose of vorinostat when given together with alvocidib in treating patients with advanced solid tumors Drugs used in chemotherapy such as vorinostat and alvocidib 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 some of the enzymes needed for cell growth Giving vorinostat together with alvocidib may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of vorinostat SAHA when given in combination with flavopiridol alvocidib in patients with advanced solid tumors
II Obtain preliminary data on the therapeutic activity of SAHA and flavopiridol in these patients
III Evaluate the role of p21 p53 and apoptotic markers relative to treatment response in patients treated with this regimen
OUTLINE This is a multicenter open label non-randomized dose-escalation study of vorinostat SAHA
Before beginning course 1 of study therapy patients receive oral SAHA on days 1-3 in order to ensure tolerability of the drug Beginning 1 week later patients receive oral SAHA once daily on days 1-3 and 8-10 and fixed-dose alvocidib intravenously IV over 1 hour on days 2 and 9 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 10 patients are treated at the MTD of SAHA in combination with fixed-dose alvocidib Once the MTD of SAHA in combination with fixed-dose alvocidib is determined patients receive oral SAHA at one dose level below the MTD once daily on days 1-3 and 8-10 and divided-dose alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 2 and 9 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity If this schedule is well-tolerated the MTD of SAHA in combination with divided-dose flavopiridol is determined as above An additional 10 patients are treated at the MTD of SAHA in combination with divided-dose alvocidib Patients undergo blood draws on days 1 and 9 of course 1 for pharmacokinetic analysis
After completion of study treatment patients are followed for 4 weeks
I Determine the maximum tolerated dose of vorinostat SAHA when given in combination with flavopiridol alvocidib in patients with advanced solid tumors
II Obtain preliminary data on the therapeutic activity of SAHA and flavopiridol in these patients
III Evaluate the role of p21 p53 and apoptotic markers relative to treatment response in patients treated with this regimen
OUTLINE This is a multicenter open label non-randomized dose-escalation study of vorinostat SAHA
Before beginning course 1 of study therapy patients receive oral SAHA on days 1-3 in order to ensure tolerability of the drug Beginning 1 week later patients receive oral SAHA once daily on days 1-3 and 8-10 and fixed-dose alvocidib intravenously IV over 1 hour on days 2 and 9 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 10 patients are treated at the MTD of SAHA in combination with fixed-dose alvocidib Once the MTD of SAHA in combination with fixed-dose alvocidib is determined patients receive oral SAHA at one dose level below the MTD once daily on days 1-3 and 8-10 and divided-dose alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 2 and 9 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity If this schedule is well-tolerated the MTD of SAHA in combination with divided-dose flavopiridol is determined as above An additional 10 patients are treated at the MTD of SAHA in combination with divided-dose alvocidib Patients undergo blood draws on days 1 and 9 of course 1 for pharmacokinetic analysis
After completion of study treatment patients are followed for 4 weeks
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-2009-00090 | REGISTRY | None | None |
| MSKCC-05109 | None | None | None |
| CDR0000472411 | None | None | None |
| NCI-6858 | None | None | None |
| 05-109 | OTHER | None | None |
| 6858 | OTHER | None | None |
| P30CA008748 | NIH | None | None |
| U01CA069856 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069856 |