Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Condition: Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Lymphoma; Leukemia; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may
      decrease side effects while stopping cancer cells from dividing so they stop growing or die.
      Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation
      may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy
      used to kill cancer cells.

      PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide
      combined with total-body irradiation and donor stem cell transplantation in treating patients
      who have hematologic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine a safe and reproducible method of adjusting the dose of cyclophosphamide based
           on its metabolism when given in combination with total body irradiation and
           hematopoietic stem cell transplantation in patients with hematologic malignancy.

      OUTLINE:

        -  Preparative regimen: Patients undergo total body irradiation twice daily on days -6 to
           -4. Patients then receive dose-adjusted (based on metabolism) cyclophosphamide IV over 1
           hour on days -3 and -2.

        -  Hematopoietic stem cell (HSC) infusion: Patients undergo allogeneic HSC transplantation
           on day 0.

      Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular
      irradiation as per institutional standard practices.

      Patients are followed daily until day 80 after transplantation and then regularly thereafter
      for survival.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): cyclophosphamide; allogeneic bone marrow transplantation; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; recurrent adult acute myeloid leukemia; untreated adult acute myeloid leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; meningeal chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; recurrent mycosis fungoides/Sezary syndrome; secondary acute myeloid leukemia; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III grade 3 follicular lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III mantle cell lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV mantle cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; recurrent adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable; noncontiguous stage II small lymphocytic lymphoma; noncontiguous stage II marginal zone lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone 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)