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

Phase 2 Completed 37 enrolled St. Jude Children's Research Hospital GlaxoSmithKline · collab National Institutes of Health (NIH) · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2002-11
Primary completion: —
Completion: 2007-10

Publications

Background 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. doi: 10.1200/JCO.2007.10.9298.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topotecan	Small molecule	1.8 mg/m2	Intravenous
Background	Pegfilgrastim	Protein / enzyme biologic	—	—
Background	filgrastim	Protein / enzyme biologic	—	—

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

Summary

Timeline

Publications

Drugs

Indications