Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00673257
First received: May 6, 2008
Last updated: August 7, 2014
Last verified: August 2014
Results First Received: October 8, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
Interventions: Drug: daunorubicin hydrochloride
Other: pharmacological study
Procedure: dual x-ray absorptimetry

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Pharmacokinetics of Daunorubicin Chemotherapy Patients  
STARTED     107  
COMPLETED     102  
NOT COMPLETED     5  
Withdrawal by Subject                 4  
Unable to obtain specimen                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Pharmacokinetics of Daunorubicin Chemotherapy Patients  
Number of Participants  
[units: participants]
  107  
Age  
[units: participants]
 
<=18 years     99  
Between 18 and 65 years     8  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  11.5  ± 5.1  
Gender  
[units: participants]
 
Female     35  
Male     72  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     19  
Not Hispanic or Latino     82  
Unknown or Not Reported     6  
Race (NIH/OMB)  
[units: participants]
 
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  



  Outcome Measures
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1.  Primary:   Population Estimates for Daunorubicinol Clearance   [ 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. ]

2.  Primary:   Population Estimates for Daunorubicinol Volume of Distribution   [ 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. ]

3.  Secondary:   Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count   [ Time Frame: Length of study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


No publications provided


Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00673257     History of Changes
Other Study ID Numbers: ABTR06C1, CDR0000490024, COG-ABTR06C1, NCI-2009-00327
Study First Received: May 6, 2008
Results First Received: October 8, 2013
Last Updated: August 7, 2014
Health Authority: United States: Federal Government