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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor|
- Response rate (complete and partial response as per RECIST criteria). [ Time Frame: 5 years ]
|Study Start Date:||November 2002|
|Study Completion Date:||October 2007|
Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
See detailed description section for additional details.
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.
|United States, Georgia|
|Atlanta, Georgia, United States, 30301|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115-6084|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Tom Baker Cancer Center|
|Calgary, Alberta, Canada, T2N 4N2|
|Alberta Children's Hospital|
|Calgary, Alberta, Canada, T2W 3N2|
|Hospital of Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Monika Metzger, MD||St. Jude Children's Research Hospital|