Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310024
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2006-03-29
Brief Title:
Vorinostat and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of SAHA in Combination With Bortezomib in Relapsed and Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-02
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 bortezomib in treating patients with relapsed or refractory multiple myeloma Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving vorinostat together with bortezomib may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of vorinostat SAHA when given together with bortezomib in patients with relapsed or refractory multiple myeloma MM
II Determine the toxicity of this regimen in these patients
SECONDARY OBJECTIVES
I Determine whether giving SAHA together with bortezomib inhibits histone deacetylation in normal cells buccal mucosal cells andor peripheral blood monocytes as well as in MM cells
II Evaluate the effect of dexamethasone when given together with SAHA and bortezomib
III Explore molecular mechanisms involved in apoptosis in MM mediated by SAHA and bortezomib
IV Correlate change of histone acetylation with clinical outcome in patients treated with this regimen
OUTLINE This is a multicenter dose escalation study of vorinostat SAHA
Patients receive bortezomib IV on days 1 4 8 and 11 followed by oral SAHA twice daily on days 4-11 Beginning in course 3 some patients may receive low-dose oral dexamethasone on days 4-8 Treatment repeats every 21 days for up to 8 courses 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 3 or 2 of 6 patients experience dose-limiting toxicity An additional cohort of 10 patients receive treatment at the MTD
Patients undergo blood collection and tumor biopsies periodically during study for pharmacologic and biomarker correlative studies
After completion of study treatment patients are followed at least once a month
I Determine the maximum tolerated dose MTD of vorinostat SAHA when given together with bortezomib in patients with relapsed or refractory multiple myeloma MM
II Determine the toxicity of this regimen in these patients
SECONDARY OBJECTIVES
I Determine whether giving SAHA together with bortezomib inhibits histone deacetylation in normal cells buccal mucosal cells andor peripheral blood monocytes as well as in MM cells
II Evaluate the effect of dexamethasone when given together with SAHA and bortezomib
III Explore molecular mechanisms involved in apoptosis in MM mediated by SAHA and bortezomib
IV Correlate change of histone acetylation with clinical outcome in patients treated with this regimen
OUTLINE This is a multicenter dose escalation study of vorinostat SAHA
Patients receive bortezomib IV on days 1 4 8 and 11 followed by oral SAHA twice daily on days 4-11 Beginning in course 3 some patients may receive low-dose oral dexamethasone on days 4-8 Treatment repeats every 21 days for up to 8 courses 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 3 or 2 of 6 patients experience dose-limiting toxicity An additional cohort of 10 patients receive treatment at the MTD
Patients undergo blood collection and tumor biopsies periodically during study for pharmacologic and biomarker correlative studies
After completion of study treatment patients are followed at least once a month
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 |
|---|---|---|---|
| CDR0000466109 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62204 |
| GCC 0514 | None | None | None |
| N01CM62204 | NIH | None | None |