Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT00673257
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2008-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Daunorubicin in Young Patients With Cancer
Sponsor:
Organization:
Raw JSON
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Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.', 'otherNumAtRisk': 107, 'otherNumAffected': 50, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bone marrow hypocellular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 30}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Fibrinogen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': '"Vascular disorders - Other, specify"', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 9}], 'organSystem': 'Infections and infestations'}, {'term': '"Infections and infestations - Other, specify"', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 9}], 'organSystem': 'Infections and infestations'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypercholestremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Lipase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Tumor lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Population Estimates for Daunorubicin Hydrochloride Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetics of Daunorubicin Chemotherapy Patients', 'description': 'Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \\< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.', 'description': 'Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.', 'unitOfMeasure': 'L/m2/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 107 patients enrolled, 4 participants withdrew consent and there was 1 patient with insufficient specimen. 4 other participants were not analyzed as all sample time points were required for analysis and were not available.'}, {'type': 'PRIMARY', 'title': 'Population Estimates for Daunorubicin Hydrochloride Volume of Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetics of Daunorubicin Chemotherapy Patients', 'description': 'Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \\< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.', 'description': 'Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 107 patients enrolled, 4 participants withdrew consent and there was 1 participant with insufficient specimen. 4 other participants were not analyzed as all samples time points were required for analysis and were not available.'}, {'type': 'SECONDARY', 'title': 'Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride', 'timeFrame': 'Length of study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (\\<30% versus \\>=30%)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background', 'timeFrame': 'Length of Study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Gender (Male versus Female), Age group (\\<median age versus \\>=median age in years), Race (White vs. Black vs. Other)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Relationship Between Pharmacokinetics and Toxicity', 'timeFrame': 'Length of Study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count', 'timeFrame': 'Length of Study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Relationship Between Pharmacokinetics, and Genetic Polymorphisms', 'timeFrame': 'Length of Study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pharmacokinetics of Daunorubicin Chemotherapy Patients', 'description': 'Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \\< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Unable to obtain specimen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pharmacokinetics of Daunorubicin Chemotherapy Patients', 'description': 'Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \\< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '5.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', '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': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2008-05-06', 'resultsFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2008-05-06', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-07', 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Population Estimates for Daunorubicin Hydrochloride Clearance', 'timeFrame': 'Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.', 'description': 'Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.'}, {'measure': 'Population Estimates for Daunorubicin Hydrochloride Volume of Distribution', 'timeFrame': 'Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.', 'description': 'Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride', 'timeFrame': 'Length of study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (\\<30% versus \\>=30%)'}, {'measure': 'Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background', 'timeFrame': 'Length of Study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Gender (Male versus Female), Age group (\\<median age versus \\>=median age in years), Race (White vs. Black vs. Other)'}, {'measure': 'Relationship Between Pharmacokinetics and Toxicity', 'timeFrame': 'Length of Study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities'}, {'measure': 'Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count', 'timeFrame': 'Length of Study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values'}, {'measure': 'Relationship Between Pharmacokinetics, and Genetic Polymorphisms', 'timeFrame': 'Length of Study', 'description': 'Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified childhood solid tumor, protocol specific'], 'conditions': ['Unspecified Childhood Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'This laboratory study is looking at the pharmacokinetics of daunorubicin in young patients with cancer. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about how patients respond to treatment with certain chemotherapy drugs.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with malignancy.\n\nSecondary\n\n* Evaluate the relationship between body composition (percent body fat) and the pharmacokinetics of daunorubicin hydrochloride in these patients.\n* Correlate the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background in these patients.\n* Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and toxicity.\n* Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and renal and hepatic function and complete blood count.\n* Explore, in a preliminary fashion, possible genetic polymorphisms that may influence daunorubicin hydrochloride disposition.\n\nOUTLINE: This is a multicenter study.\n\nPatients undergo blood collection prior to, periodically during, and after treatment with daunorubicin hydrochloride for pharmacokinetic analysis.\n\nPatients also undergo body composition testing within 7 days before or after the administration of daunorubicin hydrochloride using dual-energy x-ray absorptiometry.\n\nPROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of any malignancy\n* Must be receiving a chemotherapy regimen that includes daunorubicin hydrochloride administered as an infusion of any duration for \\< 24 hours on either a 1- or a 2-day schedule, including bolus and all short infusion schedules\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant or nursing\n* No significant uncontrolled systemic illness\n* Large implanted prostheses allowed (should not undergo dual energy x-ray absorptiometry scan)\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00673257', 'briefTitle': 'Pharmacokinetics of Daunorubicin in Young Patients With Cancer', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Pharmacokinetics of Daunomycin in Children', 'orgStudyIdInfo': {'id': 'ABTR06C1'}, 'secondaryIdInfos': [{'id': 'CDR0000490024', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'COG-ABTR06C1', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-2009-00327', 'type': 'OTHER', 'domain': 'Registry ID: CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmacokinetics of Daunorubicin chemotherapy patients', 'description': 'Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \\< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.', 'interventionNames': ['Other: pharmacological study', 'Procedure: dual x-ray absorptimetry']}], 'interventions': [{'name': 'pharmacological study', 'type': 'OTHER', 'description': 'pharmacological studies', 'armGroupLabels': ['Pharmacokinetics of Daunorubicin chemotherapy patients']}, {'name': 'dual x-ray absorptimetry', 'type': 'PROCEDURE', 'otherNames': ['DEXA scan', 'dual energy x-ray absorptimetry'], 'armGroupLabels': ['Pharmacokinetics of Daunorubicin chemotherapy patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016-7710', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305-5824', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010-2970', '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': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Cancer Care of Lee Memorial Health System', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Sacred Heart Cancer Center at Sacred Heart Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Cancer Institute at St. Joseph's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912-3730', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'MBCCOP - Medical College of Georgia Cancer Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital - Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Christ Medical Center', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40536-0093', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Lucille P. 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D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Children's Hospital and Regional Medical Center - Seattle", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99220-2555', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Cancer Center at Sacred Heart Medical Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Midwest Children's Cancer Center at Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '6001', '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': 'Hopital Sainte Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S7N 4H4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Cancer Centre at the University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Swiss Pediatric Oncology Group Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Stacey L. Berg, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Texas Children's Cancer Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}