A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187031
|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|
|Alberta Children's Hospital|
|Calgary, Alberta, Canada, T2W 3N2|
|Tom Baker Cancer Center|
|Calgary, Alberta, Canada, T2N 4N2|
|Hospital of Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Monika Metzger, MD||St. Jude Children's Research Hospital|