A Phase I Study of Sorafenib and Cyclophosphamide/Topotecan for Recurrent or Persistent Neuroblastoma

Full Title

A Phase I Study of Sorafenib and Cyclophosphamide/Topotecan in Patients with Relapsed and Refractory Neuroblastoma (NANT N2013-02)

Purpose

Cyclophosphamide and topotecan are standard chemotherapy drugs used to treat neuroblastoma. Laboratory studies suggest that the drug sorafenib can enhance the effectiveness of cyclophosphamide/topotecan against neuroblastoma cells. The purpose of this study is to find the highest dose of sorafenib that can be given safely with cyclophosphamide/topotecan in children and young adults with neuroblastoma that has come back or continued to grow despite therapy.

Sorafenib is approved for treating liver, kidney, and thyroid cancer in adults; its use in this study is considered investigational. Sorafenib is taken orally (by mouth), while cyclophosphamide/topotecan is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be age 30 or younger and have high-risk neuroblastoma that has come back or continued to grow despite prior therapy.
  • Patients must recover from the serious side effects of previous treatments before entering the study.

For more information about this study and to inquire about eligibility, please contact Dr. Stephen Roberts at 212-639-4034.

Protocol

15-121

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases

Locations