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NCT00187031 Clinical Trial

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

Wilms Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00187031
Other study ID # WILTOP
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated June 3, 2008
Start date November 2002
Est. completion date October 2007

Study information
Verified date June 2008
Source St. Jude Children's Research Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Topotecan, Filgrastim (G-CSF), Pegfilgrastim
See detailed description section for additional details.

Locations
Country Name City State
Canada Alberta Children's Hospital Calgary Alberta
Canada Tom Baker Cancer Center Calgary Alberta
Canada Hospital of Sick Children Toronto Ontario
United States Children's Healthcare Atlanta Georgia
United States Dana Farber Boston Massachusetts
United States Baylor College of Medicine Houston Texas
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (3)
Lead Sponsor Collaborator
St. Jude Children's Research Hospital GlaxoSmithKline, National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate (complete and partial response as per RECIST criteria). 5 years
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