Childhood Acute Lymphoblastic LeukemiaNCT00674193
Evaluating Dactinomycin and Vincristine in Young Patients With Cancer
An observational study of Childhood Acute Lymphoblastic Leukemia and Childhood Rhabdomyosarcoma, run by Children's Oncology Group at 38 sites in 3 countries.
Trial summary
This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Childhood Acute Lymphoblastic Leukemia, Childhood Rhabdomyosarcoma, Childhood Soft Tissue Sarcoma
- What is being tested?
- pharmacological study and laboratory biomarker analysis
- How many people
- 158 participants
- Where
- 38 sitesin 3 countries
- Study dates
- Feb 2008to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with a diagnosis of cancer, including, but not limited to, any of the following: Acute lymphoblastic leukemia, Ewing sarcoma, Rhabdomyosarcoma, Soft tissue sarcoma, Wilms tumor who are due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial
Who may be able to join
- Diagnosis of cancer, including, but not limited to, any of the following:
- Acute lymphoblastic leukemia
- Ewing sarcoma
- Rhabdomyosarcoma
- Soft tissue sarcoma
- Wilms tumor
Show all 9Show fewer
- Due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial
- Able to comply with study requirements
- Other concurrent chemotherapeutic agents allowed
Who cannot join
None listed.
Trial locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
United States36 sites
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Mission Hospitals Inc
Asheville, North Carolina, 28801
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois
Chicago, Illinois, 60612
Childrens Memorial Hospital
Chicago, Illinois, 60614
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, 32207-8426
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Miller Children's Hospital
Long Beach, California, 90806
Children's Hospital Los Angeles
Los Angeles, California, 90027
Kosair Children's Hospital
Louisville, Kentucky, 40202
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
Columbia University Medical Center
New York, New York, 10032
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453
Childrens Hospital of Orange County
Orange, California, 92868-3874
Nemours Childrens Clinic - Orlando
Orlando, Florida, 32806
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Rady Children's Hospital - San Diego
San Diego, California, 92123
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, 33607
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Australia1 site
Princess Margaret Hospital for Children
Perth, Western Australia, 6008
About this study
Official title: A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer
This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.
II. To identify demographic or physiological factors that are determinants of dactinomycin disposition.
III. To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer.
IV. To identify demographic or physiological factors that are determinants of VCR disposition.
SECONDARY OBJECTIVES:
- To examine the correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes.
II. To explore the PK, pharmacodynamic, and pharmacogenetic relationships of dactinomycin and VCR in children with cancer.
OUTLINE: This is a multicenter study.
Patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine.
After the final pharmacokinetic sample is collected, patients are followed for up to 6 months.
- Conditions
- Childhood Acute Lymphoblastic Leukemia, Childhood Rhabdomyosarcoma, Childhood Soft Tissue Sarcoma, Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)
- Being tested
- pharmacological study, laboratory biomarker analysis
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Sarcoma, Ewing, Neuroectodermal Tumors, Primitive, Peripheral, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (pharmacological study) | Patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine. Receives: Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population PK parameters for dactinomycin and VCR
Measured: Not Provided
Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition
Measured: Not Provided
Secondary outcomes (5)
Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)
Measured: Not Provided
Pharmacogenetic profiles of patients receiving dactinomycin and VCR
Measured: Not Provided
Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children
Measured: Not Provided
Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes
Measured: Not Provided
Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes
Measured: Not Provided
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 startFeb 2008
- Primary completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Acute Lymphoblastic LeukemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Skolnik, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674193
- Sponsor's protocol ID
- ADVL06B1
- Other IDs
- NCI-2009-00362, COG-ADVL06B1, CDR0000559243, U10CA098543
- Status last verified
- May 2017
- First submitted
- 6 May 2008
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer
- ClinicalTrials.gov ID
- NCT00674193
- Acronym / sponsor ID
- ADVL06B1
- Conditions
- Childhood Acute Lymphoblastic Leukemia, Childhood Rhabdomyosarcoma, Childhood Soft Tissue Sarcoma, Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2008
- Primary completion
- 30 Jun 2016 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Not posted in the source record
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 evaluating how well dactinomycin and vincristine work in treating young patients with cancer. Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.
II. To identify demographic or physiological factors that are determinants of dactinomycin disposition.
III. To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer.
IV. To identify demographic or physiological factors that are determinants of VCR disposition.
SECONDARY OBJECTIVES:
- To examine the correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes.
II. To explore the PK, pharmacodynamic, and pharmacogenetic relationships of dactinomycin and VCR in children with cancer.
OUTLINE: This is a multicenter study.
Patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine.
After the final pharmacokinetic sample is collected, patients are followed for up to 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (pharmacological study) | – | Other: pharmacological study, Other: laboratory biomarker analysisPatients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with a diagnosis of cancer, including, but not limited to, any of the following: Acute lymphoblastic leukemia, Ewing sarcoma, Rhabdomyosarcoma, Soft tissue sarcoma, Wilms tumor who are due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial
Key inclusion criteria (9 listed)
- Diagnosis of cancer, including, but not limited to, any of the following:
- Due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial
- Able to comply with study requirements
- Other concurrent chemotherapeutic agents allowed
Key exclusion criteria (0 listed)
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 studyAlso: pharmacological studiesCorrelative studies | Other | Observational (pharmacological study) |
| laboratory biomarker analysisCorrelative studies | Other | Observational (pharmacological study) |
Primary outcome
Population PK parameters for dactinomycin and VCR
Time frame: Not Provided
Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition
Time frame: Not Provided
5 secondary outcomes
Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)
Time frame: Not Provided
Pharmacogenetic profiles of patients receiving dactinomycin and VCR
Time frame: Not Provided
Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children
Time frame: Not Provided
Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes
Time frame: Not Provided
Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes
Time frame: Not Provided
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
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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.
Jeffrey Skolnik principal investigator
Children's Oncology Group
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Acute Lymphoblastic Leukemia and Childhood Rhabdomyosarcoma, run by Children's Oncology Group at 38 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Australia, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 PK parameters for dactinomycin and VCR (time frame: Not Provided). 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 17 May 2017.