Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-30 @ 7:06 AM
Study NCT ID:
NCT00006234
Status:
COMPLETED
Last Update Posted:
2011-12-01
First Post:
2000-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D012208', 'term': 'Rhabdomyosarcoma'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'C093387', 'term': "holmium-1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetrakis(methylenephosphonic acid)"}], 'ancestors': [{'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-30', 'studyFirstSubmitDate': '2000-09-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent childhood rhabdomyosarcoma', 'recurrent adult soft tissue sarcoma', 'adult rhabdomyosarcoma', 'bone metastases', 'previously treated childhood rhabdomyosarcoma', 'metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor', 'recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor', 'stage IV adult soft tissue sarcoma'], 'conditions': ['Metastatic Cancer', 'Sarcoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Radioactive drugs, such as holmium Ho 166 DOTMP, may carry radiation directly to cancer cells and not harm normal cells. Peripheral stem cell transplantation may be able to replace stem cells that were destroyed by the radioactive drug.\n\nPURPOSE: This Phase I/II trial is studying the effectiveness of holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients who have metastatic Ewing's sarcoma or rhabdomyosarcoma that has spread to the bone.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the dosimetry of holmium Ho 166 DOTMP in patients with metastatic Ewing's sarcoma family of tumors or rhabdomyosarcoma with bone metastases.\n* Provide treatment with holmium Ho 166 DOTMP for these patients.\n* Determine the toxicity and pharmacokinetics of this drug in these patients.\n* Determine the change in tumor cell content in peripheral blood and bone marrow after treatment with this drug in these patients.\n\nOUTLINE: Patients receive a trace dose of holmium Ho 166 DOTMP IV over 10 minutes on day -7 and an assigned dose over 10 minutes on day 0. Autologous peripheral blood stem cells are infused on days 7-10.\n\nPatients are followed at least weekly for 4 weeks and then monthly for 1 year or until disease progression.\n\nPROJECTED ACCRUAL: A total of 4 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed Ewing's sarcoma family of tumors or rhabdomyosarcoma with bone metastases\n\n * Refractory to conventional therapy OR\n * Responsive to conventional therapy with osseous metastases at diagnosis that are extensive enough to preclude concurrent radiotherapy to all sites\n* Soft tissue, pulmonary, and/or bone marrow metastases in addition to cortical bone allowed\n\n * Extraosseous sites of disease allowed if amenable to surgical resection or external beam radiotherapy\n* No patients under 10 years old with embryonal rhabdomyosarcoma\n* Adequate peripheral blood stem cells stored\n\n * At least 2,500,000 CD34+ cells/kg\n* No impending bone fracture or spinal cord compression\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 12 and over\n\nPerformance status:\n\n* 0-2\n\nLife expectancy:\n\n* At least 2 months\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,000/mm\\^3\n* Platelet count at least 75,000/mm\\^3 (transfusion independent)\n* Hemoglobin at least 10.0 g/dL (RBC transfusion allowed)\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times normal\n* SGOT no greater than 2.5 times normal\n\nRenal:\n\n* Radioisotope glomerular filtration rate, iothalamate clearance, or creatinine clearance at least 60 mL/min\n\nOther:\n\n* No uncontrolled infection\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Recovered from prior immunotherapy\n* At least 3 months since prior bone marrow or peripheral blood stem cell transplantation (6 months for total body irradiation conditioning) and recovered\n* At least 1 week since prior cytokines\n* No immunomodulators during and for at least 4 weeks after study\n* No concurrent cytokines\n\nChemotherapy:\n\n* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\n* No more than 3 prior systemic chemotherapy regimens\n* No systemic chemotherapy during and for at least 4 weeks after study\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* See Biologic therapy\n* Recovered from prior radiotherapy\n* No prior maximum tolerable radiotherapy (greater than 30 Gy) to the spinal cord\n* No prior therapeutic doses of bone-seeking radiopharmaceutical (e.g., samarium Sa 153 lexidronam pentasodium EDTMP)\n* No radiotherapy during and for at least 4 weeks after study\n\n * Local radiotherapy to any tumor site allowed provided at least 1 evaluable lesion is untreated\n\nSurgery:\n\n* See Disease Characteristics\n* No surgical resection of all bone metastases evaluable by PET during and for 1 month after study\n\nOther:\n\n* At least 4 weeks since prior bisphosphonates"}, 'identificationModule': {'nctId': 'NCT00006234', 'briefTitle': "Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone", 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': "A Phase I/II Study of 166Ho-DOTMP With Peripheral Blood Progenitor Cell Support for Refractory or Recurrent Ewing's Sarcoma Family of Tumors With Bone Disease", 'orgStudyIdInfo': {'id': '1474.00'}, 'secondaryIdInfos': [{'id': 'FHCRC-1474.00'}, {'id': 'CHMC-S-6007'}, {'id': 'NCI-G00-1842'}, {'id': 'CDR0000068159', 'type': 'REGISTRY', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE'}, {'name': 'holmium Ho 166 DOTMP', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Douglas Hawkins, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}