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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary:

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.

Sponsor: St. Jude Children's Research Hospital

Current Primary Outcome: Response rate (complete and partial response as per RECIST criteria). [ Time Frame: 5 years ]

Original Primary Outcome: To learn whether topotecan can cause shrinkage of Wilms tumors

Current Secondary Outcome:

Original Secondary Outcome: To learn if a patient's genetic make up affects the way the body uses topotecan

Information By: St. Jude Children's Research Hospital

Dates:
Date Received: September 12, 2005
Date Started: November 2002
Date Completion:
Last Updated: June 3, 2008
Last Verified: June 2008