Status:
COMPLETED
A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
GlaxoSmithKline
National Institutes of Health (NIH)
Conditions:
Wilms Tumor
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief 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 w...
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 starte...
Eligibility Criteria
Inclusion
- 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
- Subject is pregnant
- Subject is lactating
- Renal tumors other than Wilms tumors
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00187031
Start Date
November 1 2002
End Date
October 1 2007
Last Update
June 4 2008
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Healthcare
Atlanta, Georgia, United States, 30301
2
Dana Farber
Boston, Massachusetts, United States, 02115-6084
3
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
4
Baylor College of Medicine
Houston, Texas, United States, 77030