Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182637
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2005-09-15
Brief Title:
Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Bortezomib VELCADE in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma CTCL
Status:
COMPLETED
Status Verified Date:
2016-01
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 tumor 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 relapsed or refractory cutaneous T-cell lymphoma
PURPOSE This phase II trial is studying how well bortezomib works in treating patients with relapsed or refractory cutaneous T-cell lymphoma
Detailed Description:
OBJECTIVES
Determine the response rates complete response and partial response and duration of response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with bortezomib
Determine the safety and tolerability of this drug in these patients
OUTLINE This is an open-label study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 1 month and then at least every 3 months for 2 years or until disease progression
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study
Determine the response rates complete response and partial response and duration of response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with bortezomib
Determine the safety and tolerability of this drug in these patients
OUTLINE This is an open-label study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 1 month and then at least every 3 months for 2 years or until disease progression
PROJECTED ACCRUAL A total of 15-25 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-VEL-04-103 | None | None | None |
| UCLA-0405014-02 | None | None | None |