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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborators: GlaxoSmithKline; National Institutes of Health (NIH)
• Treatments: Topotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• Subject is pregnant

• Subject is lactating

• Renal tumors other than Wilms tumors