Hershey, Pennsylvania 17033


Purpose:

RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. PURPOSE: This phase II trial is studying how well umbilical cord blood works as a source of stem cells in treating patients with types of cancer as well as other diseases.


Study summary:

OBJECTIVES: Primary - Determine the impact of the use of umbilical cord blood as a source of hematopoietic stem cells for children with life-threatening oncologic, hematologic, or genetic/metabolic disorders in need of a stem cell transplant. - Compare the incidence of graft-versus-host disease in patients receiving cord blood transplants in this study with historical data for unrelated donor stem cell transplants. - Compare the incidence of engraftment in patients receiving cord blood transplants in this study with historical data for unrelated donor stem cell transplants. OUTLINE: - Preparative therapy: Patients are treated on 1 of 4 preparative therapy regimens. - Regimen A: Patients undergo total body irradiation (TBI) two times daily on days -7 to -4. Patients receive cyclophosphamide IV over 30-60 minutes on days -3 and -2 and anti-thymocyte globulin (ATG) IV over at least 6 hours on days -3 to -1. - Regimen B (patients who do not receive TBI): Patients receive oral busulfan 4 times daily on days -8 to -5, and ATG IV over at least 6 hours and melphalan IV over 15-20 minutes on days -4 to -2. - Regimen C (patients with Fanconi's anemia and related disorders): Patients undergo TBI on day -6. Patients receive ATG IV over at least 6 hours and methylprednisolone IV on days -5 to -1 and fludarabine IV over 30 minutes and cyclophosphamide IV over 30-60 minutes on days -5 to -2. - Regimen D: Patients receive oral or IV busulfan 4 times daily on days -9 to -5, ATG IV over at least 6 hours on days -5 to -3, and cyclophosphamide IV over 30-60 minutes on days -5 to -2. - Cord blood transplant: All patients undergo umbilical cord blood transplantation on day 0. - Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice daily beginning on day -1. Patients also receive methylprednisolone IV twice daily beginning on day 5 and continuing until at least day 28. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of malignant or non-malignant disease, including but not limited to any of the following: - Acute myeloid leukemia or acute lymphoblastic leukemia (ALL) with resistant disease beyond first clinical remission (CR) - ALL in first CR at high-risk because of 1 of the following factors: - Hypoploidy - Pseudodiploidy with translocations t(9;22), t(4;11), or t(8;14) - Elevated WBC at diagnosis as follows: - > 100,000/mm^3 for patients 6-12 months of age - > 50,000/mm^3 for patients 10-20 years of age - > 20,000/mm^3 for patients 21 years of age - Burkitt's lymphoma/leukemia - Chronic myelogenous leukemia in first chronic phase or beyond - Juvenile myelomonocytic leukemia - Advanced stage or relapsed lymphoma - Advanced stage or relapsed solid tumors, including any of the following: - Neuroblastoma - Ewing's sarcoma - Rhabdomyosarcoma - Myelodysplastic syndromes, excluding patients with grade 3 or 4 myelofibrosis - Familial erythrophagocytic histiocytosis - Histiocytosis unresponsive to medical management - Inborn errors of metabolism - Langerhans cell histiocytosis unresponsive to medical management - Immune deficiencies, including: - Severe combined immune deficiency - Wiskott-Aldrich - Hemoglobinopathies, including sickle cell disease and thalassemia - Severe aplastic anemia - Fanconi's anemia - Metabolic storage diseases - Unrelated cord blood donor must be HLA-identical OR may be mismatched for 1, 2, or 3 HLA-loci (A, B, DR) - No other existing HLA-identical related donor available at the time of transplantation PATIENT CHARACTERISTICS: Age - 21 and under Performance status - Not specified Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Not specified Renal - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00084695


Primary Contact:

Study Chair
Kenneth G. Lucas, MD
Milton S. Hershey Medical Center


Backup Contact:

N/A


Location Contact:

Hershey, Pennsylvania 17033
United States

Kenneth G. Lucas, MD
Phone: 717-531-6012
Email: klucas@psu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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