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

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.

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