Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as rituximab, 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. Drugs used in chemotherapy, such
      as cyclophosphamide, work in different ways to stop the growth of cancer cells either by
      killing the cells or by stopping them from dividing. Vaccines made from another person's
      cancer cells may help the body build an effective immune response to kill cancer cells.
      Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells

      PURPOSE: This phase I/II trial is studying how well giving rituximab together with
      cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin
      lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety and tolerability of rituximab and high-dose cyclophosphamide
           followed by vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's
           tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) as salvage therapy in patients
           with relapsed Hodgkin lymphoma.

        -  Determine the immunologic response to this vaccine in these patients.

      Secondary

        -  Determine the 3-year relapse-free and overall survival of patients treated with this
           regimen.

        -  Determine the patterns of cellular immune reconstitution in patients treated with this
           regimen.

      OUTLINE: This is an open-label study.

      Patients receive rituximab IV on days -10 and -7 and then on days 29, 36, 43, and 50 (weeks
      4-7) and high-dose (transplant-dose) cyclophosphamide IV on days -3 to 0 without stem cell
      rescue. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and
      continuing until blood counts recover. Patients also receive vaccine therapy comprising an
      allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL
      vaccine) intradermally on day 1, and weeks 4, 8, 12, 16, and 24.

      After completion of high-dose cyclophosphamide, patients are followed every 3 months for 3
      years, and then annually thereafter.

      PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
    

Intervention name(s): KGEL vaccine; Filgrastim; Rituximab; Cyclophosphamide
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1.; 5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL.; 375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.; 50 mg/kg/day on Day -3, -2, -1, and 0.
Other intervention name(s): G-CSF; Rituxan; Cytoxan
Intervention MeSH terms: Cyclophosphamide; Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult Hodgkin lymphoma