Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma

Completed · Phase 2

Conditions studied: Neuroblastoma, Medulloblastoma

In brief

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.

Key facts

Study ID

NCT00601003

Run by

Giselle Sholler

People needed

112

Starts

2008-01-14

Expected to finish

2022-10-28

Last updated by the study team

2024-08-06

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 0-21 years at the time of diagnosis.
• Diagnosis: Histologic verification at either the time of original diagnosis or relapse of neuroblastoma or medulloblastoma.
• Disease Status: Refractory or first or multiple relapsed neuroblastoma, or medulloblastoma that has relapsed after, or is refractory to, a chemotherapy-containing treatment regimen.
• Measurable disease, including at least one of the following:
• Measurable tumor by CT or MRI
• For neuroblastoma patients only, a positive MIBG (MIBG not required if subject's neuroblastoma is previously determined to not uptake MIBG), abnormal urinary catecholamine levels, or positive bone marrow biopsy/aspirate.
• For medulloblastoma patients only, positive CSF cytology
• Current disease state must be one for which there is currently no known curative therapy.
• A negative urine pregnancy test is required for female participants of child bearing potential (≥13 years of age).
• Organ Function Requirements Patients without bone marrow metastases must have an ANC > 500/μl and platelet count >50,000/μl.
• Patients must have adequate liver function as defined by AST or ALT <10x normal
• Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines

You may not qualify if…

• Life expectancy <2 months or Lansky score <50%
• Investigational Drugs: Patients who are currently receiving another investigational drug are excluded from participation.
• Anti-cancer Agents: Patients who are currently receiving other anticancer agents are not eligible. Patients must have fully recovered from the effects of prior chemotherapy, generally at least 3 weeks from the most recent administration (6 weeks for nitrosoureas).
• Infection: Patients who have an uncontrolled infection are not eligible until the infection is judged to be well controlled.
• Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
• Compensation for travel related expenses may be available

Where it is running

• 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 — St 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

Full record on ClinicalTrials.gov

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