Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-29 @ 8:13 AM
Study NCT ID:
NCT00084695
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2004-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005199', 'term': 'Fanconi Anemia'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D054429', 'term': 'Leukemia, Myelomonocytic, Juvenile'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D029502', 'term': 'Anemia, Hypoplastic, Congenital'}, {'id': 'D000741', 'term': 'Anemia, Aplastic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000080984', 'term': 'Congenital Bone Marrow Failure Syndromes'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2004-06-10', 'studyFirstSubmitQcDate': '2004-06-10', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of the use of umbilical cord blood as a source of hematopoietic stem cells'}, {'measure': 'Comparison of the incidence of graft-vs-host disease with historical data'}, {'measure': 'Comparison of the incidence of engraftment with historical data'}]}, 'conditionsModule': {'keywords': ['childhood myelodysplastic syndromes', 'recurrent childhood rhabdomyosarcoma', 'unspecified childhood solid tumor, protocol specific', 'previously treated childhood rhabdomyosarcoma', 'previously untreated childhood rhabdomyosarcoma', 'disseminated neuroblastoma', 'regional neuroblastoma', 'recurrent neuroblastoma', 'metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor', 'recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor', 'recurrent childhood acute lymphoblastic leukemia', 'juvenile myelomonocytic leukemia', 'childhood acute lymphoblastic leukemia in remission', 'childhood Burkitt lymphoma', 'recurrent childhood lymphoblastic lymphoma', 'stage III childhood lymphoblastic lymphoma', 'stage IV childhood lymphoblastic lymphoma', 'recurrent childhood small noncleaved cell lymphoma', 'stage III childhood small noncleaved cell lymphoma', 'stage IV childhood small noncleaved cell lymphoma', 'recurrent childhood large cell lymphoma', 'stage III childhood large cell lymphoma', 'stage IV childhood large cell lymphoma', 'stage III childhood Hodgkin lymphoma', 'stage IV childhood Hodgkin lymphoma', 'previously treated myelodysplastic syndromes', 'Fanconi anemia', 'de novo myelodysplastic syndromes', 'secondary myelodysplastic syndromes', 'childhood chronic myelogenous leukemia', 'chronic phase chronic myelogenous leukemia', 'relapsing chronic myelogenous leukemia', 'childhood Langerhans cell histiocytosis', 'recurrent childhood acute myeloid leukemia', 'recurrent/refractory childhood Hodgkin lymphoma'], 'conditions': ['Childhood Langerhans Cell Histiocytosis', 'Fanconi Anemia', 'Leukemia', 'Lymphoma', 'Myelodysplastic Syndromes', 'Neuroblastoma', 'Sarcoma', 'Unspecified Childhood Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy.\n\nPURPOSE: 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.', 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* 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.\n* 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.\n* Compare the incidence of engraftment in patients receiving cord blood transplants in this study with historical data for unrelated donor stem cell transplants.\n\nOUTLINE:\n\n* Preparative therapy: Patients are treated on 1 of 4 preparative therapy regimens.\n\n * 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.\n * 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.\n * 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.\n * 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.\n* Cord blood transplant: All patients undergo umbilical cord blood transplantation on day 0.\n* 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.\n\nPROJECTED ACCRUAL: A total of 25 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of malignant or non-malignant disease, including but not limited to any of the following:\n\n * Acute myeloid leukemia or acute lymphoblastic leukemia (ALL) with resistant disease beyond first clinical remission (CR)\n * ALL in first CR at high-risk because of 1 of the following factors:\n\n * Hypoploidy\n * Pseudodiploidy with translocations t(9;22), t(4;11), or t(8;14)\n * Elevated WBC at diagnosis as follows:\n\n * \\> 100,000/mm\\^3 for patients 6-12 months of age\n * \\> 50,000/mm\\^3 for patients 10-20 years of age\n * \\> 20,000/mm\\^3 for patients 21 years of age\n * Burkitt's lymphoma/leukemia\n * Chronic myelogenous leukemia in first chronic phase or beyond\n * Juvenile myelomonocytic leukemia\n * Advanced stage or relapsed lymphoma\n * Advanced stage or relapsed solid tumors, including any of the following:\n\n * Neuroblastoma\n * Ewing's sarcoma\n * Rhabdomyosarcoma\n * Myelodysplastic syndromes, excluding patients with grade 3 or 4 myelofibrosis\n * Familial erythrophagocytic histiocytosis\n * Histiocytosis unresponsive to medical management\n * Inborn errors of metabolism\n * Langerhans cell histiocytosis unresponsive to medical management\n * Immune deficiencies, including:\n\n * Severe combined immune deficiency\n * Wiskott-Aldrich\n * Hemoglobinopathies, including sickle cell disease and thalassemia\n * Severe aplastic anemia\n * Fanconi's anemia\n * Metabolic storage diseases\n* Unrelated cord blood donor must be HLA-identical OR may be mismatched for 1, 2, or 3 HLA-loci (A, B, DR)\n* No other existing HLA-identical related donor available at the time of transplantation\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 21 and under\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* See Disease Characteristics\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00084695', 'briefTitle': 'Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells', 'orgStudyIdInfo': {'id': 'CDR0000365544'}, 'secondaryIdInfos': [{'id': 'PSCI-2003-232'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regimen A', 'description': '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.', 'interventionNames': ['Biological: anti-thymocyte globulin', 'Drug: cyclophosphamide', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen B (patients who do not receive TBI)', 'description': '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.', 'interventionNames': ['Biological: anti-thymocyte globulin', 'Drug: busulfan', 'Drug: melphalan']}, {'type': 'EXPERIMENTAL', 'label': "Regimen C (patients with Fanconi's anemia/related disorders)", 'description': '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.', 'interventionNames': ['Biological: anti-thymocyte globulin', 'Drug: cyclophosphamide', 'Drug: fludarabine phosphate', 'Drug: methylprednisolone', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen D', 'description': '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.', 'interventionNames': ['Biological: anti-thymocyte globulin', 'Drug: busulfan', 'Drug: cyclophosphamide']}], 'interventions': [{'name': 'anti-thymocyte globulin', 'type': 'BIOLOGICAL', 'description': 'Given IV', 'armGroupLabels': ['Regimen A', 'Regimen B (patients who do not receive TBI)', "Regimen C (patients with Fanconi's anemia/related disorders)", 'Regimen D']}, {'name': 'busulfan', 'type': 'DRUG', 'description': 'Given orally', 'armGroupLabels': ['Regimen B (patients who do not receive TBI)', 'Regimen D']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Regimen A', "Regimen C (patients with Fanconi's anemia/related disorders)", 'Regimen D']}, {'name': 'fludarabine phosphate', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ["Regimen C (patients with Fanconi's anemia/related disorders)"]}, {'name': 'melphalan', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Regimen B (patients who do not receive TBI)']}, {'name': 'methylprednisolone', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ["Regimen C (patients with Fanconi's anemia/related disorders)"]}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Patients undergo radiation therapy two times daily on days -7 to -4.', 'armGroupLabels': ['Regimen A', "Regimen C (patients with Fanconi's anemia/related disorders)"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033-0850', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenneth G. Lucas, MD', 'role': 'CONTACT', 'email': 'klucas@psu.edu', 'phone': '717-531-6012'}], 'facility': 'Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Kenneth G. Lucas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kenneth Gerald Lucas', 'oldOrganization': "Penn State Children's Hospital"}}}}