A Phase I Study of Difluoromethylornithine and Celecoxib with Cyclophosphamide and Topotecan in Patients with Recurrent or Persistent Neuroblastoma

Full Title

Phase I Study of Difluoromethylornithine (DFMO) and Celecoxib with Cyclophosphamide/Topotecan for Patients with Relapsed or Refractory Neuroblastoma (NANT 2012-01)

Purpose

Cyclophosphamide and topotecan are anticancer drugs used in the treatment of neuroblastoma, a type of nervous system cancer that most often affects children. In this study, researchers want to find the highest dose of a drug called difluoromethylornithine (DFMO) that can be given with the drug celecoxib, along with cyclophosphamide and topotecan, in children and young adults with neuroblastoma that has come back or continued to grow despite other treatments.

DFMO is used to treat a type of brain infection, and has also been found to block the production of certain chemicals (called polyamines) which are important for cancer cell growth. Laboratory studies have shown that DFMO combined with celecoxib, a drug that reduces inflammation, reduced the growth of neuroblastoma tumors. It is possible that giving DFMO and celecoxib may enhance the anticancer effects of cyclophosphamide and topotecan when all of these drugs are given together.

DFMO and celecoxib are taken orally (by mouth), and cyclophosphamide and topotecan are given intravenously (by vein).

Eligibility

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

  • This study is for patients who are at least 2 years old but no older than 30 years of age.
  • Patients must 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

14-187

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases

Locations