Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187031
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2005-09-12
Brief Title:
A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 18 mgm2dosage and adjusted to attain a target systemic exposure of 80 plus or minus 10 ng-hrmleach 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 CYP3A45 genotype and the pharmacokinetics and pharmacodynamics of topotecan
To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan
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 CYP3A45 genotype and the pharmacokinetics and pharmacodynamics of topotecan
To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None