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

Sponsors and Collaborators:	St. Jude Children's Research Hospital GlaxoSmithKline National Institutes of Health (NIH)
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00187031

Purpose

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.

Condition	Intervention	Phase
Wilms Tumor	Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim	Phase II

MedlinePlus related topics: Cancer Wilms' Tumor

Drug Information available for: Topotecan hydrochloride Filgrastim Topotecan Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

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

Enrollment:	37
Study Start Date:	November 2002
Study Completion Date:	October 2007

Arms	Assigned Interventions
1	Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim See detailed description section for additional details.

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.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187031

Locations

United States, Georgia
Children's Healthcare
Atlanta, Georgia, United States, 30301
United States, Massachusetts
Dana Farber
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
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Alberta Children's Hospital
Calgary, Alberta, Canada, T2W 3N2
Canada, Ontario
Hospital of Sick Children
Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

St. Jude Children's Research Hospital

GlaxoSmithKline

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Monika Metzger, MD

St. Jude Children's Research Hospital

More Information

Additional Information:

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

Publications:

Metzger ML, Stewart CF, Freeman BB 3rd, Billups CA, Hoffer FA, Wu J, Coppes MJ, Grant R, Chintagumpala M, Mullen EA, Alvarado C, Daw NC, Dome JS. Topotecan is active against Wilms' tumor: results of a multi-institutional phase II study. J Clin Oncol. 2007 Jul 20;25(21):3130-6.

Responsible Party:	St. Jude Children's Research Hospital ( Monika Metzger, MD )
Study ID Numbers:	WILTOP
Study First Received:	September 12, 2005
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00187031 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:

Wilms Tumor

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Urologic Neoplasms
Recurrence
Neoplastic Syndromes, Hereditary
Renal Cancer

Urologic Diseases
Genetic Diseases, Inborn
Kidney Neoplasms
Wilms' Tumor
Wilms Tumor
Kidney Diseases
Topotecan

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Neoplastic Syndromes, Hereditary
Urologic Diseases
Genetic Diseases, Inborn
Kidney Neoplasms
Therapeutic Uses
Wilms Tumor
Kidney Diseases
Topotecan
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on May 07, 2009