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

Phase 2

Completed

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 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Overall Response	Duration of treatment (up to 10 years)	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.

Secondary Outcome Measures

Name	Time	Method
12 Month Overall Survival Rate	12 months	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	6 months	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.

Locations (56): Tunnell Cancer Center at Beebe Medical Center
🇺🇸
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
🇺🇸
Newark, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸
Washington, District of Columbia, United States
St. Joseph Medical Center
🇺🇸
Bloomington, Illinois, United States
Graham Hospital
🇺🇸
Canton, Illinois, United States
Memorial Hospital
🇺🇸
Carthage, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸
Chicago, Illinois, United States
Eureka Community Hospital
🇺🇸
Eureka, Illinois, United States
Galesburg Clinic, PC
🇺🇸
Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸
Galesburg, Illinois, United States
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Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States