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

Inclusion Criteria

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