NCT02030964CompletedPhase 1
N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan
N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan for Patients With Relapsed or Refractory Neuroblastoma
Source: ClinicalTrials.gov · Last updated 17 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 2 Jan 2014
- Start date
- Jan 2014
- Primary completion date
- Dec 2023
- Lead sponsor
- New Approaches to Neuroblastoma Therapy Consortium
- Diseases
- Neuroblastoma, Childhood cancers
- NCT number
- NCT02030964
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From Jan 2014 to the primary completion date, Dec 2023
- 13 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients status post allogeneic stem cell transplant.
- Patients who have had a seizure within 12 months prior to enrollment and patients receiving anti-convulsant therapy for a seizure disorder.
Other illness
- Patients with disease of any major organ system that would compromise their ability to withstand therapy.
- Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria.
- Patients with active bleeding of the GI tract or patients who have symptoms associated with stomach irritation (known as gastritis).
- Patients with known Aspirin-Hypersensitivity triad (asthma, allergic rhinitis, ASA hypersensitivity).
- Patients with known hypersensitivity to celecoxib or other NSAIDs, aspirin or sulfonamides.
Other
- Females of childbearing potential that do not have a negative pregnancy test.
- Patients that are pregnant, breast feeding, or unwilling to use effective contraception during the study
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Patients who are on hemodialysis.
Who the study is looking for
- Patients must be \> 2 years and \< 30 years of age when registered on study.
- Patients must have recurrent/progressive high-risk neuroblastoma, refractory high-risk neuroblastoma that had less than a partial response to standard treatment or persistent high-risk neuroblastoma that had at least a partial response to standard treatment.
- All patients must have at least ONE site of evaluable disease.
- Patients must have adequate heart, kidney, liver and bone marrow function.
- Patients who have bone marrow disease must still have adequate bone marrow function to enter the study.
- Patients with other ongoing serious medical issues must be approved by the study chair prior to registration.
Age in the registry: 2 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sydney Childrens Hospital KCC Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| C S Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children Hospital of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Childrens Hospital Boston, Dana-Farber Cancer Institute. Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Chicago Comer Children's Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cook Children's Medical Center - Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| UCSF Helen Diller Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Children's Hospital and Regional Medical Center - Seattle Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.