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Clinical trialNCT02030964CompletedPhase 1Interventional

N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan

SponsorNew Approaches to Neuroblastoma Therapy ConsortiumEnrollment30Neuroblastoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV chemotherapy medicines called cyclophosphamide and topotecan. * To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and topotecan without causing severe side effects. * To find out the side effects seen by giving DFMO at different dose levels with celecoxib, cyclophosphamide and topotecan. * To measure the levels of DFMO in the blood at different dose levels. * To determine if your tumor gets smaller after treatment with DFMO, celecoxib, cyclophosphamide and topotecan. * To determine if specific gene changes in you or your tumor makes you more prone to side effects or affects your tumor's response to the combination of DFMO, celecoxib, cyclophosphamide and topotecan. * To determine if the amount of normal chemicals in your body called polyamines go down in response to DFMO, celecoxib, cyclophosphamide and topotecan, and whether you are more likely to have a good response to the treatment if they do.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Sydney Childrens Hospital Kcc

    Randwick, Australia

Canada
  • Hospital for Sick Children

    Toronto, Ontario, Canada

United States
  • Children'S Hospital Los Angeles

    Los Angeles, California, United States

  • Ucsf Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, United States

  • Children Hospital of Colorado

    Aurora, Colorado, United States

  • Aflac Cancer Center and Blood Disorders Service of Children'S Healthcare of Atlanta - Egleston Campus

    Atlanta, Georgia, United States

  • University of Chicago Comer Children'S Hospital

    Chicago, Illinois, United States

  • Childrens Hospital Boston, Dana-Farber Cancer Institute.

    Boston, Massachusetts, United States

  • C.S Mott Children'S Hospital

    Ann Arbor, Michigan, United States

  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

  • Cook Children'S Medical Center - Fort Worth

    Fort Worth, Texas, United States

  • Children'S Hospital and Regional Medical Center - Seattle

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Jan 2014
Primary completion
30 Dec 2023
Completion
30 Dec 2023
Last update posted
17 Feb 2025
Registered enrollment
30
Registry id
NCT02030964

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.