Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066508
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2003-08-06
Brief Title:
Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study Of PS-341 VELCADE In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma DLBCL
Status:
COMPLETED
Status Verified Date:
2013-01
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 cancer cells by blocking the enzymes necessary for cancer cell growth
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have diffuse large B-cell lymphoma that is refractory to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have diffuse large B-cell lymphoma that is refractory to previous chemotherapy
Detailed Description:
OBJECTIVES
Determine the overall response rate in patients with chemotherapy-refractory diffuse large B-cell lymphoma treated with bortezomib
Determine the safety and tolerability of this drug in these patients
Determine the time to disease progression in patients treated with this drug
Determine the possible mechanism of resistance to this drug in these patients
OUTLINE This is an open-label multicenter 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
Patients are followed at 20 days and then every 3 months thereafter
PROJECTED ACCRUAL A total of 22-40 patients will be accrued for this study
Determine the overall response rate in patients with chemotherapy-refractory diffuse large B-cell lymphoma treated with bortezomib
Determine the safety and tolerability of this drug in these patients
Determine the time to disease progression in patients treated with this drug
Determine the possible mechanism of resistance to this drug in these patients
OUTLINE This is an open-label multicenter 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
Patients are followed at 20 days and then every 3 months thereafter
PROJECTED ACCRUAL A total of 22-40 patients will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0301090 | None | None | None |