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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Biological: galiximab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00516217

U10CA031946 (U.S. NIH Grant/Contract)

CALGB-50602

CDR0000561185 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Galaximab

Experimental group

Description:

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

Treatment:

Biological: galiximab