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
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
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