An interventional study of pharmacological study and dual x-ray absorptimetry in Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by Children's Oncology Group. Completed at 60 sites in 4 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2020-04-14.
Sponsored by Children's Oncology Group · Not applicable, Interventional, and Basic science
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.
Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
Other: pharmacological study · Procedure: dual x-ray absorptimetry
pharmacological studies
Also known as: DEXA scan, dual energy x-ray absorptimetry
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.
Time frame: 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.
Time frame: 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.
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%)
Time frame: Length of study
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)
Time frame: Length of Study
Relationship Between Pharmacokinetics and Toxicity
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities
Time frame: 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
Time frame: Length of Study
Relationship Between Pharmacokinetics, and Genetic Polymorphisms
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype
Time frame: Length of Study
| Milestone | Pharmacokinetics of Daunorubicin Chemotherapy Patients |
|---|---|
| Started | 107 |
| Completed | 102 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Unable to obtain specimen | 1 |
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.
| L/m2/hr | Pharmacokinetics of Daunorubicin Chemotherapy Patients |
|---|---|
| Population Estimates for Daunorubicin Hydrochloride Clearance | 116 ± 14 |
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.
| Liter | Pharmacokinetics of Daunorubicin Chemotherapy Patients |
|---|---|
| Population Estimates for Daunorubicin Hydrochloride Volume of Distribution | 68.1 ± 24 |
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (\<30% versus \>=30%)
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities
Results for this outcome have not been posted.
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values
Results for this outcome have not been posted.
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pharmacokinetics of Daunorubicin Chemotherapy Patients | — | 0/107 (0%) | 50/107 (46.7%) |
| Event | Pharmacokinetics of Daunorubicin Chemotherapy Patients |
|---|---|
| White blood cell decreasedBlood and lymphatic system disorders | 33/107 |
| Neutrophil count decreasedBlood and lymphatic system disorders | 30/107 |
| Platelet count decreasedBlood and lymphatic system disorders | 27/107 |
| AnemiaBlood and lymphatic system disorders | 26/107 |
| Lymphocyte count decreasedBlood and lymphatic system disorders | 21/107 |
| Febrile neutropeniaInfections and infestations | 9/107 |
| "Infections and infestations - Other, specify"Infections and infestations | 9/107 |
| Alanine aminotransferase increasedMetabolism and nutrition disorders | 8/107 |
| HyperglycemiaMetabolism and nutrition disorders | 6/107 |
| HypocalcemiaMetabolism and nutrition disorders | 4/107 |
| Age, Categorical(Participants) | Pharmacokinetics of Daunorubicin Chemotherapy Patients |
|---|---|
| <=18 years | 99 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Age, Continuous(years) | Pharmacokinetics of Daunorubicin Chemotherapy Patients |
|---|---|
| Mean | 11.5 ± 5.1 |
| Sex: Female, Male(Participants) | Pharmacokinetics of Daunorubicin Chemotherapy Patients |
|---|---|
| Female | 35 |
| Male | 72 |
| Ethnicity (NIH/OMB)(Participants) | Pharmacokinetics of Daunorubicin Chemotherapy Patients |
|---|---|
| Hispanic or Latino | 19 |
| Not Hispanic or Latino | 82 |
| Unknown or Not Reported | 6 |
| Race (NIH/OMB)(Participants) | Pharmacokinetics of Daunorubicin Chemotherapy Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 13 |
| White | 82 |
| More than one race | 2 |
| Unknown or Not Reported | 7 |
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