Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
Condition: Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Myelodysplastic Syndromes; Graft vs Host Disease; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer
      cells. Umbilical cord blood transplantation may allow doctors to give higher doses of
      chemotherapy or radiation therapy and kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and
      umbilical cord blood transplantation in treating patients with hematologic cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety, efficacy, and toxicity of using cord blood as a source
      for stem cell transplantation in patients with hematologic malignancies.

      OUTLINE: Patients undergo autologous bone marrow harvesting or peripheral stem cell
      collection prior to transplant regimen, unless the patient has acute leukemia in relapse,
      aplastic anemia, or myelodysplastic syndrome. Arm I: Patients eligible to undergo total body
      irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then
      undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG)
      IV over 10 hours on days -3 to -1. Cord blood is infused on day 0. Arm II: Patients not
      eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of
      16 doses. Cyclophosphamide, ATG, and cord blood are then administered as in arm I. All
      patients receive cyclosporine on days -2 to 180, methylprednisolone on days 5-180, and
      filgrastim (G-CSF) from day 1. Patients are followed weekly until day 180 and then monthly
      for 2 years.

      PROJECTED ACCRUAL: A total of 20 patients (10 patients per arm) will be accrued for this
      study within 4 years.
    

Intervention name(s): anti-thymocyte globulin; filgrastim; busulfan; cyclophosphamide; cyclosporine; methylprednisolone; bone marrow ablation with stem cell support; umbilical cord blood transplantation; radiation therapy
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Procedure; Procedure; Radiation
Intervention description(s): IV; IV; IV; IV; IV; IV; IV; IV; High energy X-rays
Intervention MeSH terms: Cyclosporine; Methylprednisolone; Cyclophosphamide; Busulfan; Cyclosporins; Antilymphocyte Serum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent childhood acute lymphoblastic leukemia; recurrent adult Hodgkin lymphoma; Burkitt lymphoma; refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; recurrent childhood lymphoblastic lymphoma; recurrent childhood acute myeloid leukemia; recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; relapsing chronic myelogenous leukemia; childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; meningeal chronic myelogenous leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; childhood acute lymphoblastic leukemia in remission; recurrent/refractory childhood Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult Burkitt lymphoma; secondary acute myeloid leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; graft versus host disease; recurrent childhood small noncleaved cell lymphoma; recurrent childhood large cell lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; childhood myelodysplastic syndromes