NCT01683149

Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies

Phase I, Traditional 3+3, Trial of PO Sorafenib and Topotecan in Refractory or Recurrent Pediatric Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator, but will not be recruiting locally. The purpose of this research study is to establish a dose of the combination of drugs, Topotecan and Sorafenib in children. This will be called the maximum tolerated dose. The chemotherapy in this study is a combination of Topotecan and Sorafenib. The investigators are trying to find the highest dose of Topotecan and Sorafenib that can be given safely to children with Refractory or Recurrent Pediatric Solid Malignancies. The investigators will do this by testing different doses of these drugs in different groups of children. The investigators will also study how the body processes these drugs.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Topotecan	Topotecan will be given by mouth as outlined in treatment arm.
DRUG	Sorafenib	Sorafenib will be given by mouth as outlined in treatment arm.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2012-09-11
• Last updated: 2016-03-04

Locations

9 sites across 1 country: United States