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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 February 2013 |
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Main ID: |
NCT00601003 |
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Date of registration:
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14/01/2008 |
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Primary sponsor: |
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Public title:
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Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma
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Scientific title:
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A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma. |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00601003 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Genevieve Bergendahl, RN |
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Address:
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Telephone:
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616-234-5707 |
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Email:
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genevieve.bergendahl@vai.org |
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Affiliation:
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Name:
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Giselle Sholler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Van Andle Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
N/A
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Medulloblastoma
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Neuroblastoma
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Intervention(s)
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Drug: Cyclophosphamide
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Drug: Nifurtimox
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Drug: Topotecan
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Primary Outcome(s)
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Best Radiological Response in Participants using the RECIST criteria
[Time Frame: 2 years]
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: 2 years]
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Secondary Outcome(s)
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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.
[Time Frame: 2 years]
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Evaluate the correlation between the pharmacologic serum levels of nifurtimox (in combination with cyclophosphamide and topotecan) with tumor response.
[Time Frame: 2 years]
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Quality of life and neurocognitive evaluation/questionnaire.
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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