Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-26 @ 10:50 AM
Study NCT ID:
NCT00026858
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070516', 'term': 'Intersectoral Collaboration'}], 'ancestors': [{'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-11', 'completionDateStruct': {'date': '2002-11'}, 'lastUpdateSubmitDate': '2008-03-03', 'studyFirstSubmitDate': '2001-11-14', 'studyFirstSubmitQcDate': '2001-11-14', 'lastUpdatePostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-11-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Bone Marrow Transplantation', 'Leukemia', 'Breast Cancer', 'Multiple Myeloma', 'Total Body Irradiation'], 'conditions': ['Neoplasm']}, 'referencesModule': {'references': [{'pmid': '3298176', 'type': 'BACKGROUND', 'citation': 'Tarbell NJ, Amato DA, Down JD, Mauch P, Hellman S. Fractionation and dose rate effects in mice: a model for bone marrow transplantation in man. Int J Radiat Oncol Biol Phys. 1987 Jul;13(7):1065-9. doi: 10.1016/0360-3016(87)90046-0.'}, {'pmid': '234595', 'type': 'BACKGROUND', 'citation': 'Thomas E, Storb R, Clift RA, Fefer A, Johnson FL, Neiman PE, Lerner KG, Glucksberg H, Buckner CD. Bone-marrow transplantation (first of two parts). N Engl J Med. 1975 Apr 17;292(16):832-43. doi: 10.1056/NEJM197504172921605. No abstract available.'}, {'pmid': '3279516', 'type': 'BACKGROUND', 'citation': 'Champlin RE, Goldman JM, Gale RP. Bone marrow transplantation in chronic myelogenous leukemia. Semin Hematol. 1988 Jan;25(1):74-80. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at each institution to limit toxicity and maximize therapeutic outcome.\n\nTechnically complex procedures such as total body radiation are subject to equipment failures. Such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. The purpose of this protocol is to provide backup between George Washington University Medical Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent situation.', 'detailedDescription': 'Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at each institution to limit toxicity and maximize therapeutic outcome.\n\nTechnically complex procedures such as total body radiation are subject to equipment failures. Such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. The purpose of this protocol is to provide backup between George Washington University Medical Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent situation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\nPatients must sign informed consent.\n\nSupporting institution physicians must agree that therapy is appropriate and safe.'}, 'identificationModule': {'nctId': 'NCT00026858', 'briefTitle': 'Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts', 'orgStudyIdInfo': {'id': '950003'}, 'secondaryIdInfos': [{'id': '95-C-0003'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'collaboration', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute (NCI)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}