Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
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 Hodgkin's lymphoma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma|
- Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 10 years post study entry ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Treatment of Patients with relapsed/refractory Hodgkin Lymphoma with monoclonal antibody therapy
500 mg/sq m IV infusion over 60 min on days 1,8,15,and 22 of Mon 1; then once q 4 wks until progression
- To determine the response rate (complete and overall response) in patients with relapsed or refractory Hodgkin lymphoma (HL) treated with galiximab.
- 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-PET/CT 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.