ANBL1221: A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus or Chimeric 14.18 Antibody in Children with Refractory, Relapsed or Progressive Neuroblastoma.
What is the purpose of this study?
This Phase II study is designed to compare the response rates (RR) and progression free survival (PFS) for patients with refractory, relapsed or progressive neuroblastoma receiving temsirolimus or ch14.18 in combination with irinotecan and temozolomide.
Who can participate?
Patients of all ages with refractory, relapsed, or progressive neuroblastoma are eligible for this study. Download PDF below for more information on additional inclusion criteria.
What is involved?
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.
What are the benefits?
The agent selected for further study as a result of this trial will be integrated into frontline induction therapy for future patients with high-risk neuroblastoma.