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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 |
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: | Filgrastim Topotecan hydrochloride Topotecan Granulocyte colony-stimulating factor Pegfilgrastim |
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 |
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.
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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:
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
St. Jude Children's Research Hospital |
GlaxoSmithKline |
National Institutes of Health (NIH) |
Principal Investigator: | Monika Metzger, MD | St. Jude Children's Research Hospital |
St. Jude Children's Research Hospital 
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Responsible Party: | St. Jude Children's Research Hospital ( Monika Metzger, MD ) |
Study ID Numbers: | WILTOP |
First Received: | September 12, 2005 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00187031 |
Health Authority: | United States: Food and Drug Administration |
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