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

Completed · Phase 2

Conditions studied: Wilms Tumor

In brief

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.

Key facts

Study ID

NCT00187031

Run by

St. Jude Children's Research Hospital

People needed

37

Starts

2002-11-01

Expected to finish

2007-10-01

Last updated by the study team

2008-06-04

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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