ANBL1221 A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC#683864, IND#61010) or Chimeric 14.18 Antibody (ch 14.18) (NSC#623408, IND#4308) in Children with Refractory or Progressive Neuroblastoma
What is the purpose of this trial?
Primary Objective To identify whether temsirolimus or ch14.18 is the optimal therapeutic agent to consider for further testing in a future Phase III randomized trial for treatment of newly diagnosed high-risk neuroblastoma. Secondary Objectives To compare the response rates (RR) for patients receiving temsirolimus or ch14.18 in combination with irinotecan and temozolomide. To compare the progression free survival (PFS) and overall survival (OS) rates for patients receiving temsirolimus or ch14.18 in combination with irinotecan and temozolomide. To compare the toxicities associated with temsirolimus or ch14.18 when combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma. To compare the ability to maintain intended dose intensity of all agents when temsirolimus or ch14.18 is combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma. To determine the concordance between tumor responses as defined by standard International Neuroblastoma Response Criteria (INRC) versus response per the revised INRC. To study the clinical relevance of naturally occurring anti-glycan antibodies in patients receiving ch14.18 antibody. To study the clinical relevance of NK receptor NKp30 isoforms in patients receiving ch14.18 antibody or temsirolimus.
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- Children's Oncology Group (The)
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