Busulfan, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk Ewing's Tumors
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: graft versus host disease prophylaxis/therapy; busulfan; melphalan; thiotepa; allogeneic bone marrow transplantation; allogeneic hematopoietic stem cell transplantation; peripheral blood stem cell transplantation
Intervention MeSH terms: Melphalan; Busulfan; Thiotepa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Maximum age: 40 Years
Healthy volunteers: No
Keywords: metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Summary:

      RATIONALE: Giving chemotherapy drugs, such as busulfan, melphalan, and thiotepa, before a
      donor stem cell transplant helps stop the growth of tumor cells and prepares the patient's
      bone marrow for the 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 tissues. Giving tacrolimus, sirolimus, and mycophenolate
      mofetil may stop this from happening.

      PURPOSE: This phase II trial is studying how well giving busulfan together with melphalan and
      thiotepa followed by a donor stem cell transplant works in treating patients with high-risk
      Ewing's tumors.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of high-risk tumors of the Ewing's family as defined by 1 of the following:

               -  Biopsy-proven disease with distant metastases to sites other than the lung

               -  Relapsed disease after completion of prior standard front-line therapy or
                  high-dose chemotherapy

          -  Currently in complete remission (CR) with no evidence of disease (with or without
             minimal residual disease) or very good partial remission (i.e., CR with an abnormal
             bone scan) after prior standard or high-dose chemotherapy with local control

          -  HLA-compatible stem cell donor available

               -  Compatible donors include those matched at both HLA-A, -B, -C, -DR and 1 of 2 -DQ
                  alleles by high-resolution molecular typing

               -  Related or unrelated donor

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status (PS) 70-100% (≥ 16 years old) OR Lansky PS 70-100% (< 16
             years old)

          -  LVEF > 50% at rest

          -  SGOT < 3 times upper limit of normal

          -  Bilirubin < 2.0 mg/dL (unless liver is involved with disease)

          -  Creatinine normal AND/OR creatinine clearance > 60 mL/min

          -  Lung diffusion capacity > 50% of predicted (corrected for hemoglobin) OR asymptomatic
             with a room air oxygen saturation of ≥ 98%

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active uncontrolled viral, bacterial, or fungal infection

          -  No HIV-1 or -2 positivity

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior therapy with 100 mg/m² of melphalan

          -  No prior high-dose chemotherapy requiring autologous stem cell rescue

          -  No prior radiotherapy to > 50% of the pelvic marrow space