Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00674193




Registration number
NCT00674193
Ethics application status
Date submitted
6/05/2008
Date registered
7/05/2008
Date last updated
17/05/2017

Titles & IDs
Public title
Evaluating Dactinomycin and Vincristine in Young Patients With Cancer
Scientific title
A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer
Secondary ID [1] 0 0
NCI-2009-00362
Secondary ID [2] 0 0
ADVL06B1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Acute Lymphoblastic Leukemia 0 0
Childhood Rhabdomyosarcoma 0 0
Childhood Soft Tissue Sarcoma 0 0
Ewing Sarcoma 0 0
Ewing Sarcoma of Bone 0 0
Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET) 0 0
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Wilms Tumor and Other Childhood Kidney Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - pharmacological study
Other interventions - laboratory biomarker analysis

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.


Other interventions: pharmacological study
Correlative studies

Other interventions: laboratory biomarker analysis
Correlative studies
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Population PK parameters for dactinomycin and VCR
Timepoint [1] 0 0
Not Provided
Primary outcome [2] 0 0
Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition
Timepoint [2] 0 0
Not Provided
Secondary outcome [1] 0 0
Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)
Timepoint [1] 0 0
Not Provided
Secondary outcome [2] 0 0
Pharmacogenetic profiles of patients receiving dactinomycin and VCR
Timepoint [2] 0 0
Not Provided
Secondary outcome [3] 0 0
Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children
Timepoint [3] 0 0
Not Provided
Secondary outcome [4] 0 0
Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes
Timepoint [4] 0 0
Not Provided
Secondary outcome [5] 0 0
Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes
Timepoint [5] 0 0
Not Provided

Eligibility
Key inclusion criteria
* Diagnosis of cancer, including, but not limited to, any of the following:

* Acute lymphoblastic leukemia
* Ewing sarcoma
* Rhabdomyosarcoma
* Soft tissue sarcoma
* Wilms tumor
* 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
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
158
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Rhode Island
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffrey Skolnik
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00674193