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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000490024 | Other Identifier | Clinical Trials.gov | |
| COG-ABTR06C1 | Other Identifier | Children's Oncology Group | |
| NCI-2009-00327 | Other Identifier | Registry ID: CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo blood collection prior to, periodically during, and after treatment with daunorubicin hydrochloride for pharmacokinetic analysis.
Patients also undergo body composition testing within 7 days before or after the administration of daunorubicin hydrochloride using dual-energy x-ray absorptiometry.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetics of Daunorubicin chemotherapy patients | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacological study | Other | pharmacological studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Population Estimates for Daunorubicin Hydrochloride Clearance | 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. | 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. |
| Population Estimates for Daunorubicin Hydrochloride Volume of Distribution | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride | Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (<30% versus >=30%) | Length of study |
| Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey L. Berg, MD | Texas Children's Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Phoenix Children's Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmacokinetics of Daunorubicin Chemotherapy Patients | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| dual x-ray absorptimetry | Procedure |
|
|
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) |
| Length of Study |
| Relationship Between Pharmacokinetics and Toxicity | Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities | Length of Study |
| Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count | Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values | Length of Study |
| Relationship Between Pharmacokinetics, and Genetic Polymorphisms | Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype | Length of Study |
| Phoenix |
| Arizona |
| 85016-7710 |
| United States |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Stanford Cancer Center | Stanford | California | 94305-5824 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | 33901 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | 30912-3730 | United States |
| Children's Memorial Hospital - Chicago | Chicago | Illinois | 60614 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40232 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0286 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216-4505 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89109-2306 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | 10032 | United States |
| Mission Hospitals - Memorial Campus | Asheville | North Carolina | 28801 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308-1062 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205-2696 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-9786 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37901 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Baylor University Medical Center - Houston | Houston | Texas | 77030-2399 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | United States |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | United States |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | 99220-2555 | United States |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Swiss Pediatric Oncology Group Bern | Bern | 3010 | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pharmacokinetics of Daunorubicin Chemotherapy Patients | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Population Estimates for Daunorubicin Hydrochloride Clearance | 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. | 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. | Posted | Mean | Standard Deviation | L/m2/hr | 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. |
|
|
| |||||||||||||||||||||||||
| Primary | Population Estimates for Daunorubicin Hydrochloride Volume of Distribution | 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. | 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. | Posted | Mean | Standard Deviation | Liter | 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. |
| |||||||||||||||||||||||||||
| Secondary | Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride | Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (<30% versus >=30%) | Not Posted | Length of study | Participants | |||||||||||||||||||||||||||||||
| Secondary | Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background | 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) | Not Posted | Length of Study | Participants | |||||||||||||||||||||||||||||||
| Secondary | Relationship Between Pharmacokinetics and Toxicity | Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities | Not Posted | Length of Study | Participants | |||||||||||||||||||||||||||||||
| Secondary | Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count | Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values | Not Posted | Length of Study | Participants | |||||||||||||||||||||||||||||||
| Secondary | Relationship Between Pharmacokinetics, and Genetic Polymorphisms | Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype | Not Posted | Length of Study | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pharmacokinetics of Daunorubicin Chemotherapy Patients | 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. | 0 | 107 | 50 | 107 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow hypocellular | Blood and lymphatic system disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
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| White blood cell decreased | Blood and lymphatic system disorders |
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| Lymphocyte count decreased | Blood and lymphatic system disorders |
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| Neutrophil count decreased | Blood and lymphatic system disorders |
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| Platelet count decreased | Blood and lymphatic system disorders |
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| Fibrinogen | Investigations |
| |||
| Anorexia | Metabolism and nutrition disorders |
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| Constipation | Metabolism and nutrition disorders |
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| Diarrhea | Metabolism and nutrition disorders |
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| Mucositis oral | Metabolism and nutrition disorders |
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| Nausea | Metabolism and nutrition disorders |
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| Proctitis | Metabolism and nutrition disorders |
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| Vomiting | Metabolism and nutrition disorders |
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| "Vascular disorders - Other, specify" | Vascular disorders |
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| Enterocolitis infectious | Infections and infestations |
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| Febrile neutropenia | Infections and infestations |
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| "Infections and infestations - Other, specify" | Infections and infestations |
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| Hypoalbuminemia | Metabolism and nutrition disorders |
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| Alanine aminotransferase increased | Metabolism and nutrition disorders |
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| Hypocalcemia | Metabolism and nutrition disorders |
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| Hypercholestremia | Metabolism and nutrition disorders |
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| GGT increased | Metabolism and nutrition disorders |
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| Hyperglycemia | Metabolism and nutrition disorders |
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| Lipase | Metabolism and nutrition disorders |
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| Hypophosphatemia | Metabolism and nutrition disorders |
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| Hyperkalemia | Metabolism and nutrition disorders |
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| Hypokalemia | Metabolism and nutrition disorders |
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| Hyponatremia | Metabolism and nutrition disorders |
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| Hypertriglyceridemia | Metabolism and nutrition disorders |
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| Syncope | Nervous system disorders |
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| Pain in extremity | Musculoskeletal and connective tissue disorders |
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| Headache | Nervous system disorders |
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| Pain | General disorders |
| |||
| Tumor lysis syndrome | Metabolism and nutrition disorders |
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Must obtain prior Sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 626-447-0064 | resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|