A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC# 683864, IND# 61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 623408, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma
The primary objective of this study is 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. Participants in this study have been diagnosed with relapsed or refractory neuroblastoma. Neuroblastoma (NBL) develops in nerve cells that are outside of the brain. NBL shows up as a lump or mass in the belly or near the spine in the chest, neck or pelvis. It often spreads to bone, liver, lymph nodes and bone marrow (the soft tissue in the center of bones where blood cells are made).
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