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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: galiximab


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed classical Hodgkin lymphoma (HL): Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies Fine needle aspirates are not acceptable Recurrent or refractory disease after at least two prior standard chemotherapy regimens Nodular lymphocyte predominant HL allowed Measurable disease must be present on either physical examination or imaging studies Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm Evaluable or non-measurable disease alone is not acceptable including any of the following: Bone lesions (lesions, if present, should be noted) Bone marrow involvement (if present, this should be noted) Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Ineligible for a stem cell transplantation Patients eligible for CALGB-50502 should not be considered for this study No known CNS involvement PATIENT CHARACTERISTICS: ECOG performance status 0-2 ANC ≥ 500/μL Platelet count ≥ 50,000/μL Creatinine ≤ 2.0 mg/dL Total bilirubin ≤ 2.0 mg/dL (no history of Gilbert Disease) AST ≤ 2.5 times upper limit of normal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study No known HIV infection PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered to ≤ grade 1 from all toxicities related to prior treatments At least 4 weeks since prior chemotherapy, radiotherapy, or biologic anticancer therapy Prior autologous and/or allogeneic stem cell transplantation allowed No prior anti-CD80 antibody No concurrent steroids, hormones, or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (e.g., insulin for diabetes) The use of dexamethasone and other steroidal antiemetics is prohibited unless to treat acute grade 3 or 4 monoclonal antibody-associated infusion reactions not responsive to transient discontinuation of antibody infusion or acetaminophen and diphenhydramine Dexamethasone is also allowed for re-treatment after an infusion reaction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galaximab<br>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 | Biological: galiximab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response | 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. | Duration of treatment (up to 10 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 Month Overall Survival Rate | Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method. | 12 months | 
| 6 Month Progression Free Survival Rate | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma