The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells
anti-thymocyte globulin
+ cyclophosphamide
+ radiation therapy
Anemia+79
+ Anemia, Aplastic
+ Anemia, Aplastic
Treatment Study
Summary
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, United StatesSee the location