Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
Giselle Sholler
Summary
Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study in combination with etoposide for subjects with relapsed/refractory neuroblastoma.
Description
Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study in combination with etoposide for subjects with relapsed/refractory neuroblastoma. In this study subjects will receive six 21-day cycles of Etoposide and DFMO followed by an additional 630 days of DFMO alone. Subjects will be evaluated in 3 arms: • Arm 1: Subjects who show no active disease after receiving any additional therapy for neuroblastoma that was refractory to standard induction/consolidation therapy. Refractory: Subjects with progressive disease on upfront therapy OR did not have at least PR on induc…
Eligibility
- Age range
- Up to 31 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * All patients must have a pathologically confirmed diagnosis of neuroblastoma, ≤ 30.99 years of age with history of relapsed/refractory neuroblastoma. * All patients must have completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy. * Specific Criteria by Arm: Arms 1 and 2: Subjects with no active disease: i. No evidence of residual disease by CT/MRI and MIBG scan (or PET for patients who have a history of MIBG non-avid disease). o Note: Patients with residual masses detected by CT/MRI may be considered in CR if their MIBG is negative or…
Interventions
- DrugEflornithine
DFMO (difluoromethylornithine) will be given at a dose of 1000 mg/m2 BID on each day of study.
Locations (31)
- University of Alabama/Children's of AlabamaBirmingham, Alabama
- Arkansas Children's HospitalLittle Rock, Arkansas
- UCSF Benioff Children's Hospital OaklandOakland, California
- Rady Children's HospitalSan Diego, California
- Connecticut Children's HospitalHartford, Connecticut
- Arnold Palmer Hospital for ChildrenOrlando, Florida