NCT00516217

Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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 Hodgkin's 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-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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	galiximab

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-09-01
• Completion: 2015-02-01
• First posted: 2007-08-15
• Last updated: 2016-07-06
• Results posted: 2015-02-04

Locations

56 sites across 1 country: United States