drugset / Trial / NCT02298348
Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma
Phase 1
Active not recruiting
18 enrolled
New Approaches to Neuroblastoma Therapy Consortium
Children's Healthcare of Atlanta · collabChildren's Hospital Colorado · collabChildren's Hospital Los Angeles · collabChildren's Hospital Medical Center, Cincinnati · collabCook Children's Health Care System · collabDana-Farber Cancer Institute · collabLucile Packard Children's Hospital · collabSeattle Children's Hospital · collabThe Hospital for Sick Children · collabUniversity of California, San Francisco · collabUniversity of Chicago · collabUniversity of Michigan · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-10-08
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | 100 mg/m2 | Oral |
| Subject | Sorafenib | Small molecule | 200 mg/m2 | Oral |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | Intravenous |
| Background | Topotecan | Small molecule | 0.75 mg/m2 | Intravenous |