NCT00187031

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wilms Tumor

Interventions

Type	Name	Description
DRUG	Topotecan, Filgrastim (G-CSF), Pegfilgrastim	See detailed description section for additional details.

Timeline

• Start date: 2002-11-01
• Completion: 2007-10-01
• First posted: 2005-09-16
• Last updated: 2008-06-04

Locations

7 sites across 2 countries: United States, Canada