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A Phase I Trial of Nifurtimox for Relapsed or Refractory Neuroblastoma


Phase 1
N/A
21 Years
Not Enrolling
Both
Neuroblastoma

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Trial Information

A Phase I Trial of Nifurtimox for Relapsed or Refractory Neuroblastoma


Inclusion Criteria:



1. Age: 0-21 years at the time of study entry.

2. Diagnosis: Histologic verification of neuroblastoma at original diagnosis or relapse.

3. 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).

4. Current disease state must be one for which there is currently no known curative
therapy.

5. A negative urine pregnancy test is required for female participants of child bearing
potential (>13 years of age).

6. Patients must have adequate liver function as defined by AST or ALT <10x
normal and a bilirubin <1.5mg/dl

7. 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:

1. Life expectancy <3 months

2. Investigational Drugs: Patients who are currently receiving another investigational
drug.

3. Anti-cancer Agents: Patients who are currently receiving other anticancer agents.

4. Infection: Patients who have an uncontrolled infection.

5. Patients who in the opinion of the investigator may not be able to comply with the
safety monitoring requirements of the study.

6. Patients may not receive bisphosphonates (i.e. Zometa) within 7 days of start of
therapy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Test the safety of nifurtimox in children with relapsed or refractory neuroblastoma alone and in combination with cyclophosphamide and topotecan.

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Giselle Sholler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Vermont / Vermont Children's Hospital

Authority:

United States: Food and Drug Administration

Study ID:

V0610

NCT ID:

NCT00486564

Start Date:

November 2006

Completion Date:

June 2009

Related Keywords:

  • Neuroblastoma
  • Treatment
  • Refractory or Relapsed
  • Neuroblastoma

Name

Location

St. Louis University/Cardinal Glennon Childrens Medical CenterSt. Louis, Missouri  63104
University of Vermont/Vermont Children's HospitalBurlington, Vermont  05401