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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wilms Tumor Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topotecan, Filgrastim (G-CSF), Pegfilgrastim

Drug

See detailed description section for additional details.

Primary outcomes

Response rate (complete and partial response as per RECIST criteria).

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

GlaxoSmithKline
National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2002
Study completion: 2007
First posted: Sep 16, 2005
Registry last updated: Jun 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed