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Brief Title: Safety Study of Nifurtimox for Relapsed or Refractory Neuroblastoma
Official Title: A Phase I Trial of Nifurtimox for Relapsed or Refractory Neuroblastoma
Study ID: NCT00486564
Brief Summary: There is currently no curative treatment for children with relapsed/refractory neuroblastoma, and for these children the 5 year survival rate is \<10%. As such, new therapeutic approaches are needed to treat these children. This Phase 1 clinical trial is specifically designed to test the safety and toxicity of nifurtimox when given in combination with cyclophosphamide and topotecan for the treatment of relapsed and/or refractory neuroblastoma . Prior to study opening, 3 pediatric patients with neuroblastoma have received nifurtimox in combination with this chemotherapy regimen, and all have had significant measurable responses without undue toxicity. These case reports, as well as our in vitro and in vivo investigations into the biologic effect of nifurtimox on neuroblastoma cells has prompted the development of this Phase I study. This Phase I study will involve a dose escalation trial of daily oral nifurtimox alone for one 21 day cycle of therapy, followed by continuation of nifurtimox with the addition of standard doses of cyclophosphamide (5 days) and topotecan (5 days) for 3 additional 21 day cycles. Our primary aim is to evaluate the safety of nifurtimox alone and in combination with these chemotherapy agents in multiply relapsed/refractory patients. Our secondary aim will be to evaluate the pharmacokinetics of nifurtimox as well as treatment response.
Detailed Description:
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
St. Louis University/Cardinal Glennon Childrens Medical Center, St. Louis, Missouri, United States
University of Vermont/Vermont Children's Hospital, Burlington, Vermont, United States
Name: Giselle Sholler, MD
Affiliation: University of Vermont / Vermont Children's Hospital
Role: STUDY_CHAIR