Clinical Trial

Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma

Study acronym: N2013-02
Active, Not Recruiting Phase 1
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Summary
This study will combine three drugs: sorafenib, cyclophosphamide and topotecan. Adding sorafenib to cyclophosphamide and topotecan may increase the effectiveness of this combination. The investigators first need to find out the highest dose of sorafenib that can be given safely together with cyclophosphamide and topotecan. This is the first study to test giving these three drugs together and will help determine the highest dose of sorafenib that can safely be given together with cyclophosphamide and topotecan to patients with resistant/relapsed neuroblastoma.
Protocol Amendment History 23 amendments
This ClinicalTrials.gov record has been amended 23 times since 2014-11-19; most recent amendment 2026-03-19.
Status change: Recruiting → Active, Not Recruiting 2018-08-01
Status change: Not Yet Recruiting → Recruiting 2015-04-08
Trial Details
NCT Number NCT02298348
Lead Sponsor New Approaches to Neuroblastoma Therapy Consortium
Collaborators: University of California, San Francisco, Children's Hospital Los Angeles, Lucile Packard Children's Hospital, Children's Hospital Medical Center, Cincinnati, University of Michigan, Seattle Children's Hospital, Dana-Farber Cancer Institute, The Hospital for Sick Children, Children's Healthcare of Atlanta, University of Chicago, Cook Children's Health Care System, Children's Hospital Colorado
Conditions Neuroblastoma
Enrollment 18 participants
Start Date 2015-10-08
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-23