Completed PHASE1 INTERVENTIONAL 1-arm NCT02030964

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

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

Sponsor: National Cancer Institute (NCI)

Conditions Neuroblastoma

Interventions Celecoxib Cyclophosphamide DFMO Topotecan

Updated 19 times since 2017 Last updated: Feb 13, 2025 Started: Jan 16, 2014 Primary completion: Dec 30, 2023 Completion: Dec 30, 2023

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Neuroblastoma and is currently completed. National Cancer Institute (NCI) leads this study, which shows 19 recorded versions since 2014 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

19 versions recorded

Mar 2025 — Present [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed
Sep 2024 — Mar 2025 [monthly]

Active Not Recruiting PHASE1
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE1
Mar 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE1
Feb 2023 — Mar 2024 [monthly]

Active Not Recruiting PHASE1

▶ Show 14 earlier versions

Oct 2022 — Feb 2023 [monthly]

Active Not Recruiting PHASE1
Oct 2021 — Oct 2022 [monthly]

Active Not Recruiting PHASE1
Feb 2021 — Oct 2021 [monthly]

Active Not Recruiting PHASE1
Jan 2021 — Feb 2021 [monthly]

Active Not Recruiting PHASE1
Apr 2020 — Jan 2021 [monthly]

Active Not Recruiting PHASE1
Jan 2020 — Apr 2020 [monthly]

Active Not Recruiting PHASE1
Aug 2019 — Jan 2020 [monthly]

Active Not Recruiting PHASE1
Jun 2019 — Aug 2019 [monthly]

Active Not Recruiting PHASE1
Dec 2018 — Jun 2019 [monthly]

Active Not Recruiting PHASE1
Sep 2018 — Dec 2018 [monthly]

Active Not Recruiting PHASE1
Jun 2018 — Sep 2018 [monthly]

Active Not Recruiting PHASE1
Sep 2017 — Jun 2018 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting
Feb 2017 — Sep 2017 [monthly]

Recruiting PHASE1
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE1

First recorded

Jan 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)
New Approaches to Neuroblastoma Therapy Consortium

Data source: New Approaches to Neuroblastoma Therapy Consortium

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Atlanta, United States , Aurora, United States , Boston, United States , Chicago, United States , Cincinnati, United States , Fort Worth, United States , Los Angeles, United States , Philadelphia, United States , Randwick, Australia and 3 more locations