NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Relapsed NeuroblastomaRefractory Neuroblastoma
Interventions
BIOLOGICAL

Natural Killer Cells

NK cells dose 1x 108 cells/ kg on day 8 of each cycle

DRUG

Temozolomide

Temozolomide 100mg/m2/dose PO or IV daily on Days 1-5; if given orally, must be at least one hour prior to Irinotecan. For patients whose body surface area is \<0.5m2, temozolomide dosing is based on body weight in (kg), at a dose of 3.3 mg/kg/dose.

DRUG

Irinotecan

Irinotecan 50mg/m2/dose IV daily on Days 1-5

DRUG

Dinutuximab

Dinutuximab 17.5mg/m2/dose IV daily on Days 2-5

DRUG

Sargramostim

Sargramostim 250mcg/m2/dose subcutaneous daily on Days 6-12

Trial Locations (1)

43205

RECRUITING

Nationwide Children's Hospital, Columbus

All Listed Sponsors
lead

Nationwide Children's Hospital

OTHER