Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
Study NCT ID:
NCT00416312
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2006-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D054391', 'term': 'Lymphoma, Extranodal NK-T-Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D016399', 'term': 'Lymphoma, T-Cell'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gsgouros@jhmi.edu', 'phone': '410 614 0116', 'title': 'George Sgouros, Ph.D.', 'organization': 'Johns Hopkins University, School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse event data was not collected since this was a data collection study tacked on to routine patient treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional & Patient-specific Dosimetry', 'description': 'Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tumor Absorbed Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}, {'units': 'tumor', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional & Patient-specific Dosimetry', 'description': 'Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.'}], 'classes': [{'title': 'Conventional dosimetry', 'categories': [{'measurements': [{'value': '3.01', 'spread': '3.04', 'groupId': 'OG000'}]}]}, {'title': 'Patient-specific dosimetry', 'categories': [{'measurements': [{'value': '3.41', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 4 years', 'description': 'tumor absorbed dose (Gy)', 'unitOfMeasure': 'Gy', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'tumor', 'denomUnitsSelected': 'tumor'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional & Patient-specific Dosimetry', 'description': 'Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Conventional Dosimetry', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Patient-specific Dosimetry', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'tumors not visible on imaging', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'All NHL patients treated by either Bexxar or Zevalin'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional & Patient-specific Dosimetry', 'description': 'Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Tumors could not be detected on imaging for 2 of the 9 enrolled patients'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Tumors could not be detected on imaging for 2 of the 9 enrolled patients'}], 'populationDescription': 'Patients being treated for lymphoma using I-131-labeled antibody were imaged and tumor dosimetry was performed using conventional and patient-specific dosimetry. Tumors could not be detected on imaging for 2 of the 9 enrolled patients.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2006-12-27', 'resultsFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2006-12-27', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-27', 'studyFirstPostDateStruct': {'date': '2006-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Absorbed Dose', 'timeFrame': 'up to 4 years', 'description': 'tumor absorbed dose (Gy)'}]}, 'conditionsModule': {'keywords': ['extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue', 'nodal marginal zone B-cell lymphoma', 'recurrent adult Burkitt lymphoma', 'recurrent adult diffuse large cell lymphoma', 'recurrent adult diffuse small cleaved cell lymphoma', 'recurrent adult diffuse mixed cell lymphoma', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult lymphoblastic lymphoma', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent mantle cell lymphoma', 'recurrent marginal zone lymphoma', 'recurrent small lymphocytic lymphoma', 'splenic marginal zone lymphoma', 'stage III adult Burkitt lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage III adult diffuse mixed cell lymphoma', 'stage III adult diffuse small cleaved cell lymphoma', 'stage III adult immunoblastic large cell lymphoma', 'stage III adult lymphoblastic lymphoma', 'stage III grade 1 follicular lymphoma', 'stage III grade 2 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage III mantle cell lymphoma', 'stage III marginal zone lymphoma', 'stage III small lymphocytic lymphoma', 'stage IV adult Burkitt lymphoma', 'stage IV adult diffuse large cell lymphoma', 'stage IV adult diffuse small cleaved cell lymphoma', 'stage IV adult diffuse mixed cell lymphoma', 'stage IV adult immunoblastic large cell lymphoma', 'stage IV adult lymphoblastic lymphoma', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular lymphoma', 'stage IV mantle cell lymphoma', 'stage IV marginal zone lymphoma', 'stage IV small lymphocytic lymphoma', 'Waldenström macroglobulinemia', 'contiguous stage II adult Burkitt lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'contiguous stage II adult diffuse mixed cell lymphoma', 'contiguous stage II adult diffuse small cleaved cell lymphoma', 'contiguous stage II adult immunoblastic large cell lymphoma', 'contiguous stage II adult lymphoblastic lymphoma', 'contiguous stage II grade 1 follicular lymphoma', 'contiguous stage II grade 2 follicular lymphoma', 'contiguous stage II grade 3 follicular lymphoma', 'contiguous stage II mantle cell lymphoma', 'contiguous stage II marginal zone lymphoma', 'contiguous stage II small lymphocytic lymphoma', 'noncontiguous stage II adult Burkitt lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II adult diffuse mixed cell lymphoma', 'noncontiguous stage II adult diffuse small cleaved cell lymphoma', 'noncontiguous stage II adult immunoblastic large cell lymphoma', 'noncontiguous stage II adult lymphoblastic lymphoma', 'noncontiguous stage II grade 1 follicular lymphoma', 'noncontiguous stage II grade 2 follicular lymphoma', 'noncontiguous stage II grade 3 follicular lymphoma', 'noncontiguous stage II mantle cell lymphoma', 'noncontiguous stage II marginal zone lymphoma', 'noncontiguous stage II small lymphocytic lymphoma', 'stage I adult Burkitt lymphoma', 'stage I adult diffuse large cell lymphoma', 'stage I adult diffuse mixed cell lymphoma', 'stage I adult diffuse small cleaved cell lymphoma', 'stage I adult immunoblastic large cell lymphoma', 'stage I adult lymphoblastic lymphoma', 'stage I grade 1 follicular lymphoma', 'stage I grade 2 follicular lymphoma', 'stage I grade 3 follicular lymphoma', 'stage I mantle cell lymphoma', 'stage I marginal zone lymphoma', 'stage I small lymphocytic lymphoma', 'adult grade III lymphomatoid granulomatosis', 'recurrent adult grade III lymphomatoid granulomatosis', 'primary central nervous system non-Hodgkin lymphoma', 'adult nasal type extranodal NK/T-cell lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab and yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.\n\nPURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan works in treating patients with non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Determine the relationship between estimated absorbed dose and tumor response using different dosimetric methodologies in patients with non-Hodgkin's lymphoma treated with iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan.\n* Determine the relationship between estimated absorbed dose and normal organ toxicity using different dosimetric methodologies in these patients.\n\nSecondary\n\n* Assess the difference in the dose-response relationship between dosimetric methodologies in these patients.\n* Assess the influence of prior therapy on the dose-response relationship for hematologic toxicity in these patients.\n\nOUTLINE: Patients are stratified according to planned radioimmunotherapy treatment (iodine I 131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan).\n\n* Stratum 1: Patients receive dosimetric rituximab IV followed by indium In 111 (\\^111In) ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT scans between 2-24, 48-72, and 90-120 hours after \\^111In ibritumomab tiuxetan administration. Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9.\n* Stratum 2: Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 (\\^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by \\^131I tositumomab IV over 20 minutes on approximately day 7.\n\nIn both strata, blood is collected at baseline to measure FLT-3 levels. All patients also undergo a baseline PET/CT scan.\n\nAfter completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 88 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated for NHL by rituximab or zevalin', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of non-Hodgkin's lymphoma\n* Measurable disease by CT scan or nuclear medicine imaging\n* Eligible, by standard of care criteria, for iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan treatment\n\nPATIENT CHARACTERISTICS:\n\n* No other malignancy within the past 3 years except basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of the cervix\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No alcoholism or drug abuse within the past 2 years\n* No severe emotional, behavioral, or psychiatric problems that would limit study compliance\n\nPRIOR CONCURRENT THERAPY:\n\n* No concurrent participation in another investigational drug study"}, 'identificationModule': {'nctId': 'NCT00416312', 'briefTitle': "Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Dose-Response in Radioimmunotherapy of Lymphoma', 'orgStudyIdInfo': {'id': 'J0636'}, 'secondaryIdInfos': [{'id': 'CDR0000522705', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'R01CA116477-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01CA116477-01A1', 'type': 'NIH'}, {'id': 'NA_00001712', 'type': 'OTHER', 'domain': 'JHM IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional & Patient-Specific Dosimetry', 'description': 'Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.', 'interventionNames': ['Device: Patient-specific dosimetry', 'Device: conventional dosimetry']}], 'interventions': [{'name': 'Patient-specific dosimetry', 'type': 'DEVICE', 'description': 'Tumor absorbed dose calculation using patient-specific 3D-RD dosimetry software.\n\nPatients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 (\\^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by \\^131I tositumomab IV over 20 minutes on approximately day 7.', 'armGroupLabels': ['Conventional & Patient-Specific Dosimetry']}, {'name': 'conventional dosimetry', 'type': 'DEVICE', 'description': 'Doses calculated using conventional dosimetry software.\n\nPatients receive dosimetric rituximab IV followed by indium In 111 (\\^111In) ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT scans between 2-24, 48-72, and 90-120 hours after \\^111In ibritumomab tiuxetan administration. Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9.', 'armGroupLabels': ['Conventional & Patient-Specific Dosimetry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231-2410', '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': 'George Sgouros, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}