Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: galiximab
Intervention MeSH terms: Galiximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent adult Hodgkin lymphoma; adult lymphocyte predominant Hodgkin lymphoma

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.
    

Eligibility 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