High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Condition: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving busulfan, cyclophosphamide, and
      filgrastim together with peripheral stem cell transplantation from a sibling donor works in
      treating patients with hematologic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and feasibility of using allogeneic peripheral blood progenitor
           cell infusions obtained from normal histocompatible sibling donors for reconstituting
           bone marrow and immunologic function when given after high-dose
           busulfan/cyclophosphamide in patients with a hematologic malignancy.

        -  Determine the efficacy of this treatment in these patients.

        -  Determine the ability to mobilize hematopoietic progenitor cells from normal donors
           given filgrastim (G-CSF) by determining the hematopoietic progenitor cell content of
           allogeneic peripheral blood progenitor cell collections.

        -  Determine the incidence of engraftment failures in these patients.

        -  Determine the incidence of severe acute graft-versus-host disease in these patients.

      OUTLINE: Patients receive high-dose oral busulfan every 6 hours on days -8 to -5,
      cyclophosphamide IV twice a day on days -4 and -3, and cyclosporine IV over 6 hours on day -1
      and then 10 hours on day 0 for 2 doses (allogeneic only). Allogeneic peripheral blood
      progenitor cells IV are administered on day 0.

      Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after
      completion of cell infusion and continuing until blood counts recover.

      Patients are followed every month for 2 months, every 3 months for 6 months, and then every 6
      months until disease progression.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued over a 15 month period.
    

Intervention name(s): filgrastim; busulfan; cyclophosphamide; cyclosporine; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after completion of cell infusion and continuing until blood counts recover.; high-dose oral busulfan every 6 hours on days -8 to -5; cyclophosphamide IV twice a day on days -4 and -3; cyclosporine IV over 6 hours on day -1 and then 10 hours on day 0 for 2 doses (allogeneic only); Allogeneic peripheral blood progenitor cells IV are administered on day 0.
Intervention MeSH terms: Cyclosporine; Cyclophosphamide; Busulfan; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent childhood acute lymphoblastic leukemia; recurrent adult Hodgkin lymphoma; refractory multiple myeloma; recurrent childhood lymphoblastic lymphoma; recurrent childhood acute myeloid leukemia; recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic 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; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; recurrent childhood small noncleaved cell lymphoma; recurrent childhood large cell lymphoma; recurrent mantle cell lymphoma; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable; 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; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12); childhood myelodysplastic syndromes