The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells
anti-thymocyte globulin
+ cyclophosphamide
+ radiation therapy
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 2003
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 25 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Hasta 21 Años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.4 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
ExperimentalGrupo IV
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, United StatesVer ubicación