Safety Study of Nifurtimox for Relapsed or Refractory Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT00486564|
Recruitment Status : Completed
First Posted : June 14, 2007
Last Update Posted : October 23, 2009
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|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: Nifurtimox||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Nifurtimox for Relapsed or Refractory Neuroblastoma|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||June 2009|
- Drug: Nifurtimox
Escalating dose by cohort starting at 20mg/kg/day. PO drug taken TID.
- Test the safety of nifurtimox in children with relapsed or refractory neuroblastoma alone and in combination with cyclophosphamide and topotecan. [ Time Frame: 3 months ]
- To evaluate the pharmacokinetic profile of nifurtimox alone and in combination with cyclophosphamide and topotecan. [ Time Frame: 3 months ]
- To determine the response rate to treatment with nifurtimox combined with cyclophosphamide/topotecan [ Time Frame: 3 months ]
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|Ages Eligible for Study:||up to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age: 0-21 years at the time of study entry.
- Diagnosis: Histologic verification of neuroblastoma at original diagnosis or relapse.
- Disease Status: Refractory or first or multiple relapsed neuroblastoma with measurable disease by radiographic scan (CT or MRI and MIBG), abnormal urinary catecholamine levels, or positive bone marrow biopsy/aspirate. MIBG not required if subject's neuroblastoma is previously determined to not uptake MIBG isotope (not MIBG avid).
- 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).
- Patients must have adequate liver function as defined by AST or ALT <10x normal and a bilirubin <1.5mg/dl
- Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
- Life expectancy <3 months
- Investigational Drugs: Patients who are currently receiving another investigational drug.
- Anti-cancer Agents: Patients who are currently receiving other anticancer agents.
- Infection: Patients who have an uncontrolled infection.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
- Patients may not receive bisphosphonates (i.e. Zometa) within 7 days of start of therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486564
|United States, Missouri|
|St. Louis University/Cardinal Glennon Childrens Medical Center|
|St. Louis, Missouri, United States, 63104|
|United States, Vermont|
|University of Vermont/Vermont Children's Hospital|
|Burlington, Vermont, United States, 05401|
|Study Chair:||Giselle Sholler, MD||University of Vermont / Vermont Children's Hospital|
|Responsible Party:||Giselle Sholler, MD, University of Vermont|
|Other Study ID Numbers:||
|First Posted:||June 14, 2007 Key Record Dates|
|Last Update Posted:||October 23, 2009|
|Last Verified:||October 2009|
Refractory or Relapsed
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue