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

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ClinicalTrials.gov Identifier: NCT00187031
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 4, 2008
Sponsor:
Collaborators:
GlaxoSmithKline
National Institutes of Health (NIH)
Information provided by:
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date June 4, 2008
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Response rate (complete and partial response as per RECIST criteria). [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
To learn whether topotecan can cause shrinkage of Wilms tumors
Change History Complete list of historical versions of study NCT00187031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
To learn if a patient's genetic make up affects the way the body uses topotecan
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wilms Tumor
Intervention  ICMJE Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
See detailed description section for additional details.
Study Arms  ICMJE 1
Intervention: Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
Publications * Metzger ML, Stewart CF, Freeman BB 3rd, Billups CA, Hoffer FA, Wu J, Coppes MJ, Grant R, Chintagumpala M, Mullen EA, Alvarado C, Daw NC, Dome JS. Topotecan is active against Wilms' tumor: results of a multi-institutional phase II study. J Clin Oncol. 2007 Jul 20;25(21):3130-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2007)
37
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
35
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00187031
Other Study ID Numbers  ICMJE WILTOP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Monika Metzger, MD, St. Jude Children's Research Hospital
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE
  • GlaxoSmithKline
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Monika Metzger, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP