Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262873
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2005-12-06
Brief Title:
Bortezomib in Treating Patients With Myelodysplastic Syndromes
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Phase II Pilot Study of VELCADE in Patients With MDS
Status:
COMPLETED
Status Verified Date:
2016-04
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:
RATIONALE Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase II trial is studying how well bortezomib works in treating patients with myelodysplastic syndromes
PURPOSE This phase II trial is studying how well bortezomib works in treating patients with myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of bortezomib in terms of reduced cytopenia in patients with myelodysplastic syndromes
Determine the safety and toxic effects of this drug in these patients
Secondary
Determine changes in marrow blast percentage or karyotypic profile in patients treated with this drug
OUTLINE This is an open-label study
Patients receive bortezomib IV on days 1 4 8 and 11 Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the efficacy of bortezomib in terms of reduced cytopenia in patients with myelodysplastic syndromes
Determine the safety and toxic effects of this drug in these patients
Secondary
Determine changes in marrow blast percentage or karyotypic profile in patients treated with this drug
OUTLINE This is an open-label study
Patients receive bortezomib IV on days 1 4 8 and 11 Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| MILLENNIUM-i34103-042 | None | None | None |
| URCC-U20403 | None | None | None |