Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-02-28 @ 8:35 AM
Study NCT ID:
NCT00674193
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2008-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Dactinomycin and Vincristine in Young Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D012512', 'term': 'Sarcoma, Ewing'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D009396', 'term': 'Wilms Tumor'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'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': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2008-05-06', 'studyFirstSubmitQcDate': '2008-05-06', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Population PK parameters for dactinomycin and VCR', 'timeFrame': 'Not Provided'}, {'measure': 'Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition', 'timeFrame': 'Not Provided'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)', 'timeFrame': 'Not Provided'}, {'measure': 'Pharmacogenetic profiles of patients receiving dactinomycin and VCR', 'timeFrame': 'Not Provided'}, {'measure': 'Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children', 'timeFrame': 'Not Provided'}, {'measure': 'Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes', 'timeFrame': 'Not Provided'}, {'measure': 'Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes', 'timeFrame': 'Not Provided'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Childhood Acute Lymphoblastic Leukemia', 'Childhood Rhabdomyosarcoma', 'Childhood Soft Tissue Sarcoma', 'Ewing Sarcoma', 'Ewing Sarcoma of Bone', 'Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)', 'Unspecified Childhood Solid Tumor, Protocol Specific', 'Wilms Tumor and Other Childhood Kidney Tumors']}, 'descriptionModule': {'briefSummary': 'This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.\n\nII. To identify demographic or physiological factors that are determinants of dactinomycin disposition.\n\nIII. To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer.\n\nIV. To identify demographic or physiological factors that are determinants of VCR disposition.\n\nSECONDARY OBJECTIVES:\n\nI. To examine the correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes.\n\nII. To explore the PK, pharmacodynamic, and pharmacogenetic relationships of dactinomycin and VCR in children with cancer.\n\nOUTLINE: This is a multicenter study.\n\nPatients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine.\n\nAfter the final pharmacokinetic sample is collected, patients are followed for up to 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of cancer, including, but not limited to, any of the following: Acute lymphoblastic leukemia, Ewing sarcoma, Rhabdomyosarcoma, Soft tissue sarcoma, Wilms tumor who are due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cancer, including, but not limited to, any of the following:\n\n * Acute lymphoblastic leukemia\n * Ewing sarcoma\n * Rhabdomyosarcoma\n * Soft tissue sarcoma\n * Wilms tumor\n* Due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial\n* Able to comply with study requirements\n* Other concurrent chemotherapeutic agents allowed'}, 'identificationModule': {'nctId': 'NCT00674193', 'briefTitle': 'Evaluating Dactinomycin and Vincristine in Young Patients With Cancer', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer', 'orgStudyIdInfo': {'id': 'ADVL06B1'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00362', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'COG-ADVL06B1', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CDR0000559243', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (pharmacological study)', 'description': 'Patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine.', 'interventionNames': ['Other: pharmacological study', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Observational (pharmacological study)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Observational (pharmacological study)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's Hospital", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868-3874', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital of Orange County', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital - San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Medical Center-Parnassus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32207-8426', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic - Jacksonville", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Nemours Childrens Clinic - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "Saint Joseph Children's Hospital of Tampa", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University 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'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C S Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospitals Inc', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United 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'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37916', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'East Tennessee Childrens Hospital', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78411', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': "Driscoll Children's Hospital", 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': "Methodist Children's Hospital of South Texas", 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Midwest Children's Cancer Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '6008', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Princess Margaret Hospital for Children', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hospital Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jeffrey Skolnik', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}