Spots Global Cancer Trial Database for Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma
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Trial Identification
Brief Title: Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma
Official Title: A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma.
Study ID: NCT00601003
Study Description
Brief Summary: The purpose of this study is to determine whether nifurtimox in combination with cyclophosphamide and topotecan are effective in the treatment of relapsed or refractory neuroblastoma and medulloblastoma.
Detailed Description: This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but limited early observations suggest that nifurtimox may have anti tumor activity for neuroblastoma and medulloblastoma. From the preliminary trials of nifurtimox we have determined a safely tolerated dose of nifurtimox to use in neuroblastoma patients (30mg/kg/day). The dose determined in the Phase I study to be safe, will be the dose used for this study. From clinical experience in South America, we know that children can tolerate nifurtimox when given by mouth, and it appears to have no long-term side effects when used to treat Chagas Disease. Based on our laboratory and animal studies, we believe that drug levels similar to those used to treat Chagas Disease may shrink/kill neuroblastoma cells, especially when combined with other chemotherapy drugs. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rady Children's Hospital, San Diego, California, United States
Connecticut Children's Hospital, Hartford, Connecticut, United States
Arnold Palmer Hospital for Children- MD Anderson, Orlando, Florida, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Tufts Medical Center, Boston, Massachusetts, United States
Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States
Children's Hospital and Clinics on Minnesota, Minneapolis, Minnesota, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States
Levine Children's Hospital, Charlotte, North Carolina, United States
Penn State Milton S. Hershey Medical Center and Children's Hospital, Hershey, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Children's Medical Center, Dallas, Texas, United States
Texas Children's Cancer and Hematology Centers, Houston, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
Contact Details
Name: Giselle Sholler, MD
Affiliation: Beat Childhood Cancer at Atrium Health
Role: STUDY_CHAIR
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