New Approaches to Neuroblastoma Therapy Consortium
This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.
Currently there are very few effective treatments for high-risk neuroblastoma that has returned or that has not responded to treatment. One treatment that works relatively well for this type of neuroblastoma is a combination of four medicines (dinutuximab, temozolomide, irinotecan, and GM-CSF). Dinutuximab is an antibody that attacks neuroblastoma cells. Temozolomide and irinotecan are two chemotherapy medicines. GM-CSF helps to boost the immune system. This study is trying to learn if this treatment, which is called chemoimmunotherapy, can work better by adding NK cells. The immune system i…
Inclusion Criteria: * Patients must be ≥ 1 year and ≤31 years of age at the time of enrollment on the study. * Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines. * Patients must have high-risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was initially considered low or intermediate risk but then reclassified as high-risk neuroblastoma prior to enrollment also meet this criteria. * Patients…
Patients will receive a dose of 1x108 UD TGFβi NK cells/kg per treatment cycle on day 8 of each cycle
Enteral or IV daily on days 1-5 of each cycle For patients ≥ 0.5 m2: 100 mg/m2/dose For patients \< 0.5 m2: 3.3 mg/kg/dose MAXIMUM dose = 200 mg
50mg/m2/dose IV daily on days 1-5 of each cycle
17.5mg/m2/dose IV daily on days 2-5 of each cycle
250mcg/m2/dose subcutaneous (preferred) or IV daily on days 6-12 of each cycle