Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer
Condition: Leukemia; Myelodysplastic Syndromes
MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: busulfan; cyclosporine; etoposide; mycophenolate mofetil; allogeneic bone marrow transplantation; allogeneic hematopoietic stem cell transplantation; peripheral blood stem cell transplantation; total-body irradiation
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Etoposide; Busulfan; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 16 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); recurrent adult acute myeloid leukemia; adult acute myeloid leukemia in remission; recurrent childhood acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia; blastic phase chronic myelogenous leukemia; refractory anemia with excess blasts in transformation; refractory anemia with excess blasts; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes

Summary:

      RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant
      or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and
      helps stop the patient's immune system from rejecting the donor's stem cells. When the
      healthy stem cells from a donor are infused into the patient they may help the patient's bone
      marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the
      transplanted cells from a donor can make an immune response against the body's normal cells.
      Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from
      happening.

      PURPOSE: This phase II trial is studying the side effects and best way to give busulfan
      together with etoposide and total-body irradiation and to see how well they work in treating
      patients who are undergoing a donor stem cell or bone marrow transplant for advanced
      hematologic cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of 1 of the following:

               -  Acute myeloid leukemia (AML)

                    -  Failed remission induction therapy or in relapse beyond second remission

                    -  In first remission with poor risk cytogenetics (e.g., 11q abnormalities, -7,
                       -5, complex abnormalities [i.e., > 3 abnormalities, 6;9 translocation and 3q
                       abnormalities del (7q), del (5q), complex abnormalities ≥ abnormalities, 9q,
                       20q, 21q, 17q, t(9;21)])

               -  Acute lymphoblastic leukemia (ALL)

                    -  Failed remission induction therapy or in relapse beyond second remission

               -  Blastic phase chronic myelogenous leukemia

               -  Refractory anemia with excess blasts

               -  Refractory anemia with excess blasts in transformation

          -  HLA -A, -B, -C, -DR identical sibling donor match available

          -  No relapse after prior bone marrow transplantation

        PATIENT CHARACTERISTICS:

          -  Cardiac ejection fraction ≥ 50%

          -  Serum creatinine ≤ 1.2 times upper limit of normal (ULN) or creatinine clearance > 80
             mL/min

          -  Bilirubin ≤ 1.5 times ULN

          -  AST and ALT < 5 times ULN

          -  FEV_1 ≥ 50% of predicted normal

          -  DLCO ≥ 50% of predicted normal

          -  No psychological or medical condition that would preclude allogeneic transplantation
             (in the opinion of the treating physician)

          -  Not pregnant

          -  Negative pregnancy test

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 28 days since prior induction or reinduction therapy

          -  Prior etoposide and busulfan allowed

          -  No prior radiation therapy that would exclude total-body irradiation