OncoMatch/Clinical Trials/NCT02679144
Neuroblastoma Maintenance Therapy Trial
Is NCT02679144 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Difluoromethylornithine (DFMO) for neuroblastoma.
Treatment: Difluoromethylornithine (DFMO) — Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Prior therapy
Must have received: standard upfront therapy — Stratum 1/1B: intensive induction chemotherapy and (if feasible) resection of primary tumor, followed by consolidation with high-dose chemotherapy with stem cell transplant and radiotherapy, followed by immunotherapy with Ch14.18/IL-2/GM-CSF (dinutuximab) and retinoic acid
Stratum 1/1B: All patients must have completed standard upfront therapy that replicates treatment which patients who were enrolled on ANBL0032 received, including: intensive induction chemotherapy and (if feasible) resection of primary tumor, followed by: consolidation with high-dose chemotherapy with stem cell transplant and radiotherapy, followed by: immunotherapy with Ch14.18/IL-2/GM-CSF (dinutuximab) and retinoic acid
Must have received: standard upfront therapy — Stratum 2: standard upfront therapy different from Stratum 1
Stratum 2: Neuroblastoma that is in first complete remission following standard upfront therapy different from that described for Stratum 1.
Must have received: induction chemotherapy and surgical resection — Stratum 3: failed to have a response of at least PR following induction chemotherapy and surgical resection, but achieved CR following additional therapy
Stratum 3: Neuroblastoma that failed to have a response of at least PR following induction chemotherapy and surgical resection of the primary tumor, but that has achieved CR following additional therapy.
Must have received: any prior therapy — Stratum 4: achieved a second or subsequent CR following relapse(s)
Stratum 4: Patients who have achieved a second or subsequent CR following relapse(s).
Cannot have received: investigational drug
Subjects who are currently receiving another investigational drug are excluded from participation.
Cannot have received: anticancer agents
Subjects who are currently receiving other anticancer agents are not eligible.
Lab requirements
Blood counts
total absolute phagocyte count ≥1000/μl
Kidney function
adequate renal function
Liver function
adequate liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama, Children's of Alabama · Birmingham, Alabama
- Arkansas Children's Hospital · Little Rock, Arkansas
- UCSF Benioff Children's Hospital Oakland- · Oakland, California
- Rady Children's Hospital · San Diego, California
- Rocky Mountain Pediatric Hematology · Denver, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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