What will happen in the study?
The combination of irinotecan and temozolomide with the mTOR inhibitor temsirolimus is well tolerated in children, and this 3-drug regimen will comprise one arm of this study. The second arm will include irinotecan and temozolomide in combination with the chimeric anti-GD2 antibody ch14.18.
Preclinical studies of anti-GD2 antibodies combined with cytotoxic chemotherapy have shown synergistic or additive effects on neuroblastoma cells. These data support evaluation of the addition of ch14.18 to chemotherapy for children with refractory, relapsed or progressive neuroblastoma.