Busulfan, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk Ewing's Tumors
Sarcoma

About this trial
This is an interventional treatment trial for Sarcoma focused on measuring metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Chemo followed by DSCT
Myeloablative preparative regimen: Patients receive busulfan IV over 2 hours every 6 hours on days -8 to -6, melphalan IV over 20 minutes on days -5 to -3, and thiotepa IV over 4 hours on day -2. Allogeneic hematopoietic stem cell transplant: Patients undergo allogeneic bone marrow or T-cell depleted peripheral blood stem cell transplantation on day 0. Graft-vs-host disease (GVHD) prophylaxis: Patients receive treatment according to institutional guidelines and are given treatment against infection. After completion of study treatment, patients are followed periodically for at least 3 years.