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:||Endpoint Classification: 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|
- Overall Response [ Time Frame: Duration of treatment (up to 10 years) ] [ Designated as safety issue: No ]
Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.
CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions.
- 12 Month Overall Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.
- 6 Month Progression Free Survival Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.
Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node.
|Study Start Date:||June 2008|
|Study Completion Date:||October 2014|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516217
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|Study Chair:||Sonali M. Smith, MD||University of Chicago|