Unspecified Childhood Solid Tumor, Protocol SpecificNCT00673257
Pharmacokinetics of Daunorubicin in Young Patients With Cancer
A study testing pharmacological study and dual x-ray absorptimetry in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 60 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- pharmacological study and dual x-ray absorptimetry
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 60 sitesin 4 countries
- Study dates
- Jan 2007to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Diagnosis of any malignancy
- 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
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- No significant uncontrolled systemic illness
- Large implanted prostheses allowed (should not undergo dual energy x-ray absorptiometry scan)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
60 sites in 4 countries.
60 sites in 4 countries
United States56 sites
Akron Children's Hospital
Akron, Ohio, 44308-1062
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0286
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-3730
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Nationwide Children's Hospital
Columbus, Ohio, 43205-2696
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, 33901
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 07601
Baylor University Medical Center - Houston
Houston, Texas, 77030-2399
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289
University of Mississippi Cancer Clinic
Jackson, Mississippi, 39216-4505
Nemours Children's Clinic
Jacksonville, Florida, 32207
East Tennessee Children's Hospital
Knoxville, Tennessee, 37901
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89109-2306
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, 40536-0093
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Kosair Children's Hospital
Louisville, Kentucky, 40232
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, 32504
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-9786
Phoenix Children's Hospital
Phoenix, Arizona, 85016-7710
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, 99220-2555
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
All Children's Hospital
St. Petersburg, Florida, 33701
Stanford Cancer Center
Stanford, California, 94305-5824
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, 33607
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Canada2 sites
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, S7N 4H4
Australia1 site
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
About this study
Official title: Pharmacokinetics of Daunomycin in Children
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.
Read the detailed description
OBJECTIVES:
Primary
- Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with malignancy.
Secondary
- Evaluate the relationship between body composition (percent body fat) and the pharmacokinetics of daunorubicin hydrochloride in these patients.
- Correlate the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background in these patients.
- Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and toxicity.
- Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and renal and hepatic function and complete blood count.
- Explore, in a preliminary fashion, possible genetic polymorphisms that may influence daunorubicin hydrochloride disposition.
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.
- Being tested
- pharmacological study, dual x-ray absorptimetry
- Keywords
- unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacological studies
dual x-ray absorptimetryProcedure or surgery
Also called DEXA scan, dual energy x-ray absorptimetry
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: pharmacological study; Procedure: dual x-ray absorptimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 outcomes (5)
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%)
Measured: 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)
Measured: Length of Study
Relationship Between Pharmacokinetics and Toxicity
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities
Measured: 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
Measured: Length of Study
Relationship Between Pharmacokinetics, and Genetic Polymorphisms
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype
Measured: Length of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2011
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stacey L. Berg, MD, Study chair, Texas Children's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673257
- Sponsor's protocol ID
- ABTR06C1
- Other IDs
- CDR0000490024, COG-ABTR06C1, NCI-2009-00327
- Status last verified
- Feb 2020
- First submitted
- 6 May 2008
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Daunomycin in Children
- ClinicalTrials.gov ID
- NCT00673257
- Acronym / sponsor ID
- ABTR06C1
- Keywords
- unspecified childhood solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with malignancy.
Secondary
- Evaluate the relationship between body composition (percent body fat) and the pharmacokinetics of daunorubicin hydrochloride in these patients.
- Correlate the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background in these patients.
- Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and toxicity.
- Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and renal and hepatic function and complete blood count.
- Explore, in a preliminary fashion, possible genetic polymorphisms that may influence daunorubicin hydrochloride disposition.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetics of Daunorubicin chemotherapy patients | Experimental | Other: pharmacological study, Procedure: dual x-ray absorptimetryPatients 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. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacological studypharmacological studies | Other | Pharmacokinetics of Daunorubicin chemotherapy patients |
| dual x-ray absorptimetryAlso: DEXA scan, dual energy x-ray absorptimetry | Procedure or surgery | Pharmacokinetics of Daunorubicin chemotherapy patients |
Primary outcome
Population Estimates for Daunorubicin Hydrochloride 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.
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.
Population Estimates for Daunorubicin Hydrochloride 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.
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.
5 secondary outcomes
Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride
Time frame: Length of study
Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background
Time frame: Length of Study
Relationship Between Pharmacokinetics and Toxicity
Time frame: Length of Study
Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count
Time frame: Length of Study
Relationship Between Pharmacokinetics, and Genetic Polymorphisms
Time frame: Length of Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey L. Berg, MD study chair
Texas Children's Cancer Center
60 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacological study and dual x-ray absorptimetry in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 60 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada, Australia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population Estimates for Daunorubicin Hydrochloride 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.