A Phase 2 interventional study of Topotecan, Filgrastim (G-CSF), Pegfilgrastim in Wilms Tumor, sponsored by St. Jude Children's Research Hospital. Completed at 7 sites in 2 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2008-06-04.
Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Treatment
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.
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:
134 studies on the registry are indexed under Wilms Tumor; 24 are open to participants now.
This study's enrollment of 37 is above the median of 27 across 92 interventional studies indexed under Wilms Tumor.
Browse Wilms Tumor studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
See detailed description section for additional details.
Response rate (complete and partial response as per RECIST criteria).
Time frame: 5 years
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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St. Jude Children's Research Hospital