Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT01886105
Status:
TERMINATED
Last Update Posted:
2019-10-29
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061972', 'term': 'samarium Sm-153 lexidronam'}, {'id': 'D012493', 'term': 'Samarium'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D028581', 'term': 'Lanthanoid Series Elements'}, {'id': 'D008674', 'term': 'Metals, Rare Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bladle@jhmi.edu', 'phone': '443-287-3534', 'title': 'Dr. Brian H. Ladle', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study had low enrollment - 4 patients. Those that did enroll had very late stage disease and the therapy provided on this trial was the last therapy given for all 4 patients. Of the patients that began therapy, only 1 completed planned therapy.'}}, 'adverseEventsModule': {'timeFrame': 'up to 4 months', 'description': 'No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'SmEDTMP/Autologous Stem Cell Infusion/RT', 'description': 'Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Nausea grade 2 or greater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anemia', 'notes': 'Grade 2 or greater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Thrombocytopenia', 'notes': 'Grade 2 or greater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pain', 'notes': 'Grade 2 or greater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Pain from tumor requiring admission for IV pain medications.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hospitalization', 'notes': 'Shortness of breath and bronchitis admitting for antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hospitalization/Death', 'notes': 'Respiratory distress from tumor compression of airways, bleeding during airway stenting procedure leading to death.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Treated Participants With 6-month Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SmEDTMP/Autologous Stem Cell Infusion/RT', 'description': 'Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post-intervention', 'description': 'Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SmEDTMP/Autologous Stem Cell Infusion/RT', 'description': 'Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.\n\nExternal Beam Radiotherapy: The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 months', 'description': 'Number of patients experiencing any Grade 3-4 toxicity, as defined by CTCAE v4.0 and RTOG Cooperative Group Common Toxicity Criteria, during the trial intervention and follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SmEDTMP/Autologous Stem Cell Infusion/RT', 'description': 'Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy to be delivered according to the judgement of the treating radiation oncologist.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SmEDTMP/Autologous Stem Cell Infusion/RT', 'description': 'Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '11', 'upperLimit': '44'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Individual patients'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-15', 'size': 353739, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-27T12:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Low accrual and loss of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2013-06-04', 'resultsFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2013-06-21', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-11', 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Treated Participants With 6-month Progression Free Survival', 'timeFrame': '6 months post-intervention', 'description': 'Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.'}], 'secondaryOutcomes': [{'measure': 'Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity', 'timeFrame': 'Up to 48 months', 'description': 'Number of patients experiencing any Grade 3-4 toxicity, as defined by CTCAE v4.0 and RTOG Cooperative Group Common Toxicity Criteria, during the trial intervention and follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteosarcoma', 'Osteogenic Sarcoma', 'Sarcoma', 'Bone Cancer'], 'conditions': ['Metastatic Osteosarcoma']}, 'referencesModule': {'references': [{'pmid': '13207496', 'type': 'BACKGROUND', 'citation': 'FRANCIS KC, PHILLIPS R, NICKSON JJ, WOODARD HQ, HIGINBOTHAM NL, COLEY BL. Massive preoperative irradiation in the treatment of osteogenic sarcoma in children; a preliminary report. Am J Roentgenol Radium Ther Nucl Med. 1954 Nov;72(5):813-8. No abstract available.'}, {'pmid': '4506001', 'type': 'BACKGROUND', 'citation': 'Jenkin RD, Allt WE, Fitzpatrick PJ. Osteosarcoma. An assessment of management with particular reference to primary irradiation and selective delayed amputation. Cancer. 1972 Aug;30(2):393-400. doi: 10.1002/1097-0142(197208)30:23.0.co;2-2. No abstract available.'}, {'pmid': '14138', 'type': 'BACKGROUND', 'citation': 'Kang CH, Ferguson-Miller S, Margoliash E. Steady state kinetics and binding of eukaryotic cytochromes c with yeast cytochrome c peroxidase. J Biol Chem. 1977 Feb 10;252(3):919-26.'}, {'pmid': '14138245', 'type': 'BACKGROUND', 'citation': 'LEE ES, MACKENZIE DH. OSTEOSARCOMA. A STUDY OF THE VALUE OF PREOPERATIVE MEGAVOLTAGE RADIOTHERAPY. Br J Surg. 1964 Apr;51:252-74. doi: 10.1002/bjs.1800510405. No abstract available.'}, {'pmid': '2478681', 'type': 'BACKGROUND', 'citation': 'Singh A, Holmes RA, Farhangi M, Volkert WA, Williams A, Stringham LM, Ketring AR. Human pharmacokinetics of samarium-153 EDTMP in metastatic cancer. J Nucl Med. 1989 Nov;30(11):1814-8.'}, {'pmid': '7707409', 'type': 'BACKGROUND', 'citation': 'Winderen M, Kjonniksen I, Fodstad O. Pronounced therapeutic effect of samarium 153-ethylenediaminetetramethylene phosphonate in an orthotopic human osteosarcoma tibial tumor model. J Natl Cancer Inst. 1995 Feb 1;87(3):221-2. doi: 10.1093/jnci/87.3.221. No abstract available.'}, {'pmid': '2384798', 'type': 'BACKGROUND', 'citation': 'Lattimer JC, Corwin LA Jr, Stapleton J, Volkert WA, Ehrhardt GJ, Ketring AR, Anderson SK, Simon J, Goeckeler WF. Clinical and clinicopathologic response of canine bone tumor patients to treatment with samarium-153-EDTMP. 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A phase II study of treatment of painful multifocal skeletal metastases with single and repeated dose samarium-153 ethylenediaminetetramethylene phosphonate. Eur J Cancer. 1991;27(9):1084-6. doi: 10.1016/0277-5379(91)90297-q.'}, {'pmid': '8229221', 'type': 'BACKGROUND', 'citation': 'Collins C, Eary JF, Donaldson G, Vernon C, Bush NE, Petersdorf S, Livingston RB, Gordon EE, Chapman CR, Appelbaum FR. Samarium-153-EDTMP in bone metastases of hormone refractory prostate carcinoma: a phase I/II trial. J Nucl Med. 1993 Nov;34(11):1839-44.'}, {'pmid': '8679270', 'type': 'BACKGROUND', 'citation': 'Bruland OS, Skretting A, Solheim OP, Aas M. Targeted radiotherapy of osteosarcoma using 153 Sm-EDTMP. A new promising approach. Acta Oncol. 1996;35(3):381-4. doi: 10.3109/02841869609101655.'}, {'pmid': '11797510', 'type': 'BACKGROUND', 'citation': 'Franzius C, Bielack S, Flege S, Eckardt J, Sciuk J, Jurgens H, Schober O. High-activity samarium-153-EDTMP therapy followed by autologous peripheral blood stem cell support in unresectable osteosarcoma. Nuklearmedizin. 2001 Dec;40(6):215-20.'}, {'pmid': '11773169', 'type': 'BACKGROUND', 'citation': 'Anderson PM, Wiseman GA, Dispenzieri A, Arndt CA, Hartmann LC, Smithson WA, Mullan BP, Bruland OS. High-dose samarium-153 ethylene diamine tetramethylene phosphonate: low toxicity of skeletal irradiation in patients with osteosarcoma and bone metastases. J Clin Oncol. 2002 Jan 1;20(1):189-96. doi: 10.1200/JCO.2002.20.1.189.'}, {'pmid': '19338063', 'type': 'BACKGROUND', 'citation': 'Loeb DM, Garrett-Mayer E, Hobbs RF, Prideaux AR, Sgouros G, Shokek O, Wharam MD Jr, Scott T, Schwartz CL. Dose-finding study of 153Sm-EDTMP in patients with poor-prognosis osteosarcoma. Cancer. 2009 Jun 1;115(11):2514-22. doi: 10.1002/cncr.24286.'}, {'pmid': '20715156', 'type': 'BACKGROUND', 'citation': 'Loeb DM, Hobbs RF, Okoli A, Chen AR, Cho S, Srinivasan S, Sgouros G, Shokek O, Wharam MD Jr, Scott T, Schwartz CL. Tandem dosing of samarium-153 ethylenediamine tetramethylene phosphoric acid with stem cell support for patients with high-risk osteosarcoma. Cancer. 2010 Dec 1;116(23):5470-8. doi: 10.1002/cncr.25518. Epub 2010 Aug 16.'}, {'pmid': '21448934', 'type': 'BACKGROUND', 'citation': 'Ciernik IF, Niemierko A, Harmon DC, Kobayashi W, Chen YL, Yock TI, Ebb DH, Choy E, Raskin KA, Liebsch N, Hornicek FJ, Delaney TF. Proton-based radiotherapy for unresectable or incompletely resected osteosarcoma. Cancer. 2011 Oct 1;117(19):4522-30. doi: 10.1002/cncr.26037. Epub 2011 Mar 29.'}, {'pmid': '17237146', 'type': 'BACKGROUND', 'citation': 'Yang QC, Zeng BF, Dong Y, Shi ZM, Jiang ZM, Huang J. Overexpression of hypoxia-inducible factor-1alpha in human osteosarcoma: correlation with clinicopathological parameters and survival outcome. Jpn J Clin Oncol. 2007 Feb;37(2):127-34. doi: 10.1093/jjco/hyl137. Epub 2007 Jan 19.'}, {'pmid': '17043737', 'type': 'BACKGROUND', 'citation': 'Padhani AR, Krohn KA, Lewis JS, Alber M. Imaging oxygenation of human tumours. Eur Radiol. 2007 Apr;17(4):861-72. doi: 10.1007/s00330-006-0431-y. Epub 2006 Oct 17.'}, {'pmid': '7673026', 'type': 'BACKGROUND', 'citation': 'Koh WJ, Bergman KS, Rasey JS, Peterson LM, Evans ML, Graham MM, Grierson JR, Lindsley KL, Lewellen TK, Krohn KA, et al. Evaluation of oxygenation status during fractionated radiotherapy in human nonsmall cell lung cancers using [F-18]fluoromisonidazole positron emission tomography. Int J Radiat Oncol Biol Phys. 1995 Sep 30;33(2):391-8. doi: 10.1016/0360-3016(95)00170-4.'}, {'pmid': '12632200', 'type': 'BACKGROUND', 'citation': 'Rajendran JG, Wilson DC, Conrad EU, Peterson LM, Bruckner JD, Rasey JS, Chin LK, Hofstrand PD, Grierson JR, Eary JF, Krohn KA. [(18)F]FMISO and [(18)F]FDG PET imaging in soft tissue sarcomas: correlation of hypoxia, metabolism and VEGF expression. Eur J Nucl Med Mol Imaging. 2003 May;30(5):695-704. doi: 10.1007/s00259-002-1096-7. Epub 2003 Mar 11.'}, {'pmid': '15073099', 'type': 'BACKGROUND', 'citation': "Rajendran JG, Mankoff DA, O'Sullivan F, Peterson LM, Schwartz DL, Conrad EU, Spence AM, Muzi M, Farwell DG, Krohn KA. Hypoxia and glucose metabolism in malignant tumors: evaluation by [18F]fluoromisonidazole and [18F]fluorodeoxyglucose positron emission tomography imaging. Clin Cancer Res. 2004 Apr 1;10(7):2245-52. doi: 10.1158/1078-0432.ccr-0688-3."}, {'pmid': '16133382', 'type': 'BACKGROUND', 'citation': 'Hicks RJ, Rischin D, Fisher R, Binns D, Scott AM, Peters LJ. Utility of FMISO PET in advanced head and neck cancer treated with chemoradiation incorporating a hypoxia-targeting chemotherapy agent. Eur J Nucl Med Mol Imaging. 2005 Dec;32(12):1384-91. doi: 10.1007/s00259-005-1880-2. Epub 2005 Aug 26.'}, {'pmid': '20950958', 'type': 'BACKGROUND', 'citation': 'Hobbs RF, McNutt T, Baechler S, He B, Esaias CE, Frey EC, Loeb DM, Wahl RL, Shokek O, Sgouros G. A treatment planning method for sequentially combining radiopharmaceutical therapy and external radiation therapy. Int J Radiat Oncol Biol Phys. 2011 Jul 15;80(4):1256-62. doi: 10.1016/j.ijrobp.2010.08.022. Epub 2010 Oct 13.'}, {'pmid': '19378750', 'type': 'BACKGROUND', 'citation': 'Hobbs RF, Sgouros G. Calculation of the biological effective dose for piecewise defined dose-rate fits. Med Phys. 2009 Mar;36(3):904-7. doi: 10.1118/1.3070587.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.', 'detailedDescription': 'Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be between 13 and 65 years of age, inclusive\n* Must have unresectable primary tumor or metastases\n* Must have measurable disease that is demonstrated by positive Tc-99m Bone Scan. Not all lesions must be positive on bone scan.\n* Creatinine clearance \\>70ml/min/1.73m2\n* ANC \\>500/mm3\n* Platelets \\>50,000/mm3\n* Life expectancy \\> 8 weeks\n* Karnofsky performance status \\>50%\n* Stem cell product collected prior to the infusion of Samarium must be available, either by peripheral stem cell mobilization or bone marrow harvest prior to trial entry.\n\nExclusion Criteria:\n\n* Patient may not be pregnant or breastfeeding.\n* Patients who have received prior radiotherapy to all areas of current active disease are not eligible.'}, 'identificationModule': {'nctId': 'NCT01886105', 'briefTitle': 'Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma', 'orgStudyIdInfo': {'id': 'J1322'}, 'secondaryIdInfos': [{'id': 'NA_00075773', 'type': 'OTHER', 'domain': 'JHM IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SmEDTMP/Autologous Stem Cell Infusion/RT', 'description': 'DAY 1 Tracer dose 153Sm-EDTMP administration (1 mCi/kg) SPECT/High-resolution CT at 4 hours. SPECT/CT (low resolution) at 24 and 48 hrs\n\nDAY 7 Individualized treatment dose 153Sm-EDTMP administration (max 30 mCi/kg) SPECT scans at 4, 24 and 48 hours\n\nDAY 21 (2 weeks following treatment dose) Auto-Stem cell infusion\n\nDAY 40 (approx. two weeks after stem cell rescue) Initiate EBT upon count recovery\n\n1 MONTH following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET', 'interventionNames': ['Drug: Sm-EDTMP', 'Other: Autologous Stem Cell Infusion', 'Radiation: External Beam Radiotherapy']}], 'interventions': [{'name': 'Sm-EDTMP', 'type': 'DRUG', 'otherNames': ['Samarium', '153Sm-EDTMP'], 'description': 'Subjects receive a "tracer" infusion of Samarium-153 EDTMP at 1 mCi/kg. 3D dosimetry using SPECT images are obtained post "tracer" infusion to determine the distribution of dose delivered to the tumor and surrounding normal tissues. "Tracer" activity will be applied to development of the external beam radiation (EBT) planning. Second "treatment" infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg.', 'armGroupLabels': ['SmEDTMP/Autologous Stem Cell Infusion/RT']}, {'name': 'Autologous Stem Cell Infusion', 'type': 'OTHER', 'otherNames': ['Stem Cells'], 'description': 'Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.', 'armGroupLabels': ['SmEDTMP/Autologous Stem Cell Infusion/RT']}, {'name': 'External Beam Radiotherapy', 'type': 'RADIATION', 'otherNames': ['Radiation'], 'description': 'The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning.\n\nAfter the "treatment" infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the EBT portion of the treatment plan, as necessary.', 'armGroupLabels': ['SmEDTMP/Autologous Stem Cell Infusion/RT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Brian Ladle, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}