A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor - Tabular View

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

This study has been completed.

Study NCT00187031. Last updated on June 3, 2008. Information provided by St. Jude Children's Research Hospital

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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 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 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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

Condition ^†

Wilms Tumor

Intervention ^†

Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim

MEDLINE PMIDs

17634492

Links

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

November 2002

Completion Date

October 2007

Eligibility Criteria ^†

Inclusion Criteria:

Favorable histology Wilms tumor that has recurred or progressed after primary treatment and at least one standard salvage treatment regimen OR anaplastic histology Wilms tumor that has recurred or progressed after primary treatment
Age< 21 years of age at the time of study entry
Adequate bone marrow function
Adequate liver function
Adequate renal function
Adequate performance status

Exclusion Criteria:

Subject is pregnant
Subject is lactating
Renal tumors other than Wilms tumors

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada

Administrative Information Fields

NCT ID ^†

NCT00187031

Organization ID

WILTOP

Secondary IDs ^††

Study Sponsor ^†

St. Jude Children's Research Hospital

Collaborators ^††

GlaxoSmithKline
National Institutes of Health (NIH)

Investigators ^†

Principal Investigator:

Monika Metzger, MD

St. Jude Children's Research Hospital

Information Provided By

St. Jude Children's Research Hospital

Verification Date

June 2008

First Received Date ^†

September 12, 2005

Last Updated Date

June 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.