Phase 1 Study of Slower Naxitamab Infusion with Irinotecan, Temozolomide, and Sargramostim for Children and Young Adults with Relapsed or Refractory Neuroblastoma

What this Trial Is About

Researchers are studying a treatment plan using the drugs Irinotecan, Temozolomide, Sargramostim, and an immunotherapy called Naxitamab for patients aged 1 to 30 years with relapsed or refractory neuroblastoma. This phase 1 trial aims to find the safest infusion time for Naxitamab by testing different infusion durations to see if slower administration reduces side effects like pain or infusion reactions. The study is supported by YmAbs Therapeutics, and involves about 18 participants. Participants receive Naxitamab combined with Irinotecan, Temozolomide, and Sargramostim. The Naxitamab infusion duration varies between 3 to 5 hours depending on tolerance, with three levels 5 hours, 4 hours, and 3 hours. Treatment cycles last 21 days, including daily doses of Naxitamab on days 1, 3, and 5 Temozolomide and Irinotecan on days 1 to 5 and Sargramostim on days 6 to 12. Imaging scans occur during certain cycles to monitor disease. The study includes an initial baseline visit, treatment cycles up to six times, an end-of-treatment visit, and follow-up at one year. During the study, participants undergo screening for eligibility, blood tests, questionnaires, CT, MRI, MIBG scans, heart function tests, and bone marrow biopsies. Researchers track side effects, including pain during infusions, tumor response, and survival over time. Safety is monitored throughout treatment and for 35 days after the last dose. Follow-up continues quarterly for up to one year after treatment to assess progression-free and overall survival. The study lasts through the treatment cycles and a one-year follow-up period.

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma