Neuroblastoma Treatment Using Eflornithine in Chemotherapy – Phase II

Protocol Description

The goal of this Children's Oncology Group study is to determine the effects and tolerability of adding the drug eflornithine to chemotherapy using irinotecan, temozolomide, and dinutuximab for people with neuroblastoma that has come back after treatment (relapsed) or has not responded to treatment (refractory).

Study Level: II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients ages 1 year and older who have been diagnosed with relapsed or refractory neuroblastoma.
Males and Females: Ages 1 year and older

Requirements

Participants will be randomly assigned to receive either a standard COG-recommended chemotherapy regimen or the standard regimen with eflornithine added to each cycle of therapy. Participants will receive up to 6 cycles of therapy, each lasting 28 days, with evaluations to test tumor response conducted after every 2 cycles. Patients may receive 11 additional cycles for a total of 17 cycles if they do not achieve complete response, partial response or had only minor response to the initial therapy.
Visits: Number of visits can vary by individual.
Duration: About 5-1/2 months of therapy for most participants.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ANBL1821)
National Cancer Institute

Additional Information

Study Description at the National Institutes of Health
Cancer and Blood Disorder Research 

Primary Investigator

Jean M. Tersak, MD

Contact Information

For more information about the study or enrollment, please contact the UPMC Children’s Hospital of Pittsburgh Hematology-Oncology research team, at: HOCHPPhaseI-II@upmc.edu