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

NCT ID: NCT00187031

Last Updated: 2008-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Wilms Tumor

Keywords

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Wilms Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Topotecan, Filgrastim (G-CSF), Pegfilgrastim

Intervention Type DRUG

See detailed description section for additional details.

Interventions

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Topotecan, Filgrastim (G-CSF), Pegfilgrastim

See detailed description section for additional details.

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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St. Jude Children's Research Hospital

Principal Investigators

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Monika Metzger, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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Children's Healthcare

Atlanta, Georgia, United States

Site Status

Dana Farber

Boston, Massachusetts, United States

Site Status

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Tom Baker Cancer Center

Calgary, Alberta, Canada

Site Status

Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status

Hospital of Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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. doi: 10.1200/JCO.2007.10.9298.

Reference Type BACKGROUND
PMID: 17634492 (View on PubMed)

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

Other Identifiers

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WILTOP

Identifier Type: -

Identifier Source: org_study_id