A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00187031|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 4, 2008
|Condition or disease||Intervention/treatment||Phase|
|Wilms Tumor||Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor|
|Study Start Date :||November 2002|
|Actual Study Completion Date :||October 2007|
Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
See detailed description section for additional details.
- Response rate (complete and partial response as per RECIST criteria). [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|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|