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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187031
First received: September 12, 2005
Last updated: June 3, 2008
Last verified: June 2008

September 12, 2005
June 3, 2008
November 2002
Not Provided
Response rate (complete and partial response as per RECIST criteria). [ Time Frame: 5 years ]
To learn whether topotecan can cause shrinkage of Wilms tumors
Complete list of historical versions of study NCT00187031 on ClinicalTrials.gov Archive Site
Not Provided
To learn if a patient’s genetic make up affects the way the body uses topotecan
Not Provided
Not Provided
 
A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor

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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Wilms Tumor
Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
See detailed description section for additional details.
1
Intervention: Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
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.
 
Completed
37
October 2007
Not Provided

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00187031
WILTOP
Yes
Monika Metzger, MD, St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
  • GlaxoSmithKline
  • National Institutes of Health (NIH)
Principal Investigator: Monika Metzger, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
June 2008

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