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A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor

This study has been completed.
Study NCT00187031.   Last updated on June 3, 2008.   Information provided by St. Jude Children's Research Hospital

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Descriptive Information Fields
Brief Title  A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
Official Title  A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
Brief Summary

In spite of the overall success of treating Wilms tumor, certain patients still have poor clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and recurrent Wilms tumor warrant the identification of new therapeutic agents. The objective of this trial is to estimate the response rate to two cycles of intravenous topotecan in children with recurrent Wilms tumor of favorable histology that is refractory to standard curative therapy.

Detailed Description

Topotecan administered intravenously over 30 minutes daily for 5 consecutive days for 2 consecutive weeks, with a two-day rest given in between the five-day treatment blocks. The topotecan dose started at 1.8 mg/m2/dosage and adjusted to attain a target systemic exposure of 80 plus or minus 10 ng-hr/ml.each cycle consists of 28 days and subsequent cycles can be administered upon hematological recovery. Patients with a CR, PR, or SD, can continue to receive up to a total of six cycles. Patients with PD are removed from the study.

Secondary Objectives include:

  • To describe the anti-tumor activity of topotecan in children with recurrent Wilms tumor of anaplastic histology.
  • To assess the relation between CYP3A4/5 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
  • To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure  Response rate (complete and partial response as per RECIST criteria). [ Time Frame: 5 years ]
Secondary Outcome Measure 
Condition  Wilms Tumor
Intervention  Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
MEDLINE PMIDs 17634492
Links St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  37
Start Date  November 2002
Completion Date October 2007
Eligibility Criteria 

Inclusion Criteria:

  • Favorable histology Wilms tumor that has recurred or progressed after primary treatment and at least one standard salvage treatment regimen OR anaplastic histology Wilms tumor that has recurred or progressed after primary treatment
  • Age< 21 years of age at the time of study entry
  • Adequate bone marrow function
  • Adequate liver function
  • Adequate renal function
  • Adequate performance status

Exclusion Criteria:

  • Subject is pregnant
  • Subject is lactating
  • Renal tumors other than Wilms tumors
Gender Both
Ages up to 21 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00187031
Organization ID WILTOP
Secondary IDs ††
Study Sponsor  St. Jude Children's Research Hospital
Collaborators †† GlaxoSmithKline
National Institutes of Health (NIH)
Investigators 
Principal Investigator:     Monika Metzger, MD     St. Jude Children's Research Hospital    
Information Provided By St. Jude Children's Research Hospital
Verification Date June 2008
First Received Date  September 12, 2005
Last Updated Date June 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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