Donor White Blood Cell Infusions and Interleukin-2 in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed Advanced Lymphoid Cancer
Condition: Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Graft vs Host Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing. An
      autologous stem cell transplant using the patient's stem cells may be able to replace
      blood-forming cells that were destroyed by chemotherapy. Giving white blood cells from a
      donor may help the patient's body destroy any remaining cancer cells. Interleukin-2 may
      stimulate the white blood cells to kill cancer cells.

      PURPOSE: This phase I/II trial is studying the side effects of donor white blood cell
      infusions and interleukin-2 and to see how well they work in treating patients who are
      undergoing an autologous stem cell transplant for relapsed advanced lymphoid cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the feasibility and toxicity of haploidentical related donor lymphocyte
           infusions (DLI) and interleukin-2, in terms of acute graft-versus-host-disease, graft
           failure, and transplant-related mortality, in patients with relapsed advanced lymphoid
           malignancies undergoing autologous stem cell transplantation.

      Secondary

        -  Determine the extent, degree, and duration of donor chimerism in patients treated with
           this regimen.

        -  Determine, preliminarily, activity of haploidentical DLI, as measured by complete
           response rate, in these patients.

      OUTLINE: This is a pilot study.

      Patients receive high-dose melphalan IV over 15-60 minutes on day -2 and undergo autologous
      stem cell transplantation on day 0. Patients receive haploidentical related donor lymphocyte
      infusions (DLI) IV on days 1, 5*, and 10* and interleukin-2 (IL-2) IV continuously on days
      1-12.

      NOTE: *DLI are not administered on days 5 or 10 if grade 3 or 4 graft-versus-host disease is
      present

      After completion of study treatment, patients are followed monthly for 3 months and then
      every 3-12 months thereafter.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): aldesleukin; therapeutic allogeneic lymphocytes; melphalan; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Drug; Procedure; Procedure
Intervention MeSH terms: Aldesleukin; Melphalan
Primary purpose: Treatment
Keywords: graft versus host disease; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma; refractory chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; recurrent small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; recurrent mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma