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Spots Global Cancer Trial Database for N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan

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Trial Identification

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

Official Title: N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan for Patients With Relapsed or Refractory Neuroblastoma

Study ID: NCT02030964

Conditions

Neuroblastoma

Study Description

Brief Summary: 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 2 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Sydney Childrens Hospital KCC, Randwick, , Australia

Hospital for Sick Children, Toronto, Ontario, Canada

Contact Details

Name: Michael Hogarty, MD

Affiliation: Children's Hospital of Philadelphia

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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