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Protocol Summary


Protocol No.
PSHCI-14-008
Prinicipal Investigator
Brown, Valerie
Phase
Phase II
Age Group
Both
Scope
National
Secondary Protocol No.
V0706
Title
A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma.
Objective
OBJECTIVES
3B Primary Objective:
4B Test the efficacy (best response) and safety of nifurtimox in children with relapsed or refractory neuroblastoma or medulloblastoma, in combination with cyclophosphamide/topotecan
5B Evaluate Mean Time to Progression
Nifurtimox Phase II: Nifurtimox for Neuroblastoma and Medulloblastoma V0706 Secondary Objectives:
7B Evaluate the correlation between the pharmacologic serum levels of nifurtimox with tumor response.
8B Quality of life and neurocognitive evaluation/questionnaire.
9B Biology studies to include: genomic analysis of cells pre- and post- treatment, correlation of in vitro response to in vivo response, flow cytometry of tumor burden in bone marrow and biomarker development.
Applicable Disease Sites
Brain and Nervous System
Drugs Involved
NIFURTIMOX
Status
Open
Participating Institutions
Hershey Medical Center
Contact
Name
Suzanne Treadway
Phone No.
+1 717-531-3097
E-mail
streadway@hmc.psu.edu