Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516217
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2007-08-14
Brief Title:
Galiximab in Treating Patients With Relapsed or Refractory Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of Galiximab Anti-CD80 for Patients With RelapsedRefractory Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-07
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 Monoclonal antibodies such as galiximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them
PURPOSE This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkins lymphoma
PURPOSE This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
To determine the response rate complete and overall response in patients with relapsed or refractory Hodgkin lymphoma HL treated with galiximab
Secondary
To assess the duration of response progression-free survival and overall survival of patients with relapsed or refractory HL
To assess the safety and tolerability of galiximab in patients with relapsed or refractory HL
To determine if FDG-PET correlates with outcome in patients with relapsed or refractory HL treated with galiximab
OUTLINE This is a multicenter study
Induction therapy Patients receive galiximab IV over 60 minutes on days 1 8 15 and 22 in month 1
Extended induction therapy Patients receive galiximab IV over 60 minutes once every four weeks in the absence of disease progression or unacceptable toxicity
Patients also undergo FDG-PETCT imaging at baseline and at time of first restaging within 7 days prior to week 8 treatment
After completion of study treatment patients are followed periodically for 10 years
Primary
To determine the response rate complete and overall response in patients with relapsed or refractory Hodgkin lymphoma HL treated with galiximab
Secondary
To assess the duration of response progression-free survival and overall survival of patients with relapsed or refractory HL
To assess the safety and tolerability of galiximab in patients with relapsed or refractory HL
To determine if FDG-PET correlates with outcome in patients with relapsed or refractory HL treated with galiximab
OUTLINE This is a multicenter study
Induction therapy Patients receive galiximab IV over 60 minutes on days 1 8 15 and 22 in month 1
Extended induction therapy Patients receive galiximab IV over 60 minutes once every four weeks in the absence of disease progression or unacceptable toxicity
Patients also undergo FDG-PETCT imaging at baseline and at time of first restaging within 7 days prior to week 8 treatment
After completion of study treatment patients are followed periodically for 10 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 |
|---|---|---|---|
| CDR0000561185 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-50602 | None | None | None |