Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082966
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2004-05-14
Brief Title:
Bortezomib in Treating Patients With Relapsed or Refractory Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of PS-341 Bortezomib in Patients With Relapsed or Refractory Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkins lymphoma Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkins lymphoma using overall response rate as the primary efficacy endpoint
II To assess time to progression and 2-year overall survival after bortezomib therapy
III To evaluate the safety and tolerability of bortezomib in patients with relapsedrefractory Hodgkins lymphoma
OUTLINE This is a 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 rapid disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
I To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkins lymphoma using overall response rate as the primary efficacy endpoint
II To assess time to progression and 2-year overall survival after bortezomib therapy
III To evaluate the safety and tolerability of bortezomib in patients with relapsedrefractory Hodgkins lymphoma
OUTLINE This is a 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 rapid disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-50206 | None | None | None |
| CDR0000361745 | None | None | None |