N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan
Public ClinicalTrials.gov record NCT02030964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan for Patients With Relapsed or Refractory Neuroblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02030964
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 30 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 16, 2014 (Actual)
- Primary completion
- Dec 30, 2023 (Actual)
- Completion
- Dec 30, 2023 (Actual)
- Last update posted
- Feb 17, 2025
2014 – 2023
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027-0700 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| Children Hospital of Colorado | Aurora | Colorado | 80045 | — |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | — |
| University of Chicago Comer Children's Hospital | Chicago | Illinois | 60637 | — |
| Childrens Hospital Boston, Dana-Farber Cancer Institute. | Boston | Massachusetts | 02115 | — |
| C.S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | — |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | — |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02030964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 17, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02030964 live on ClinicalTrials.gov.