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A Phase II Randomized Trial of Irinotecan/Temozolomide With Temsirolimus (NSC# 683864) or Chimeric 14.18 Antibody (Ch14.18) (NSC# 764038) in Children With Refractory, Relapsed or Progressive Neuroblastoma

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Trial Profile

A Phase II Randomized Trial of Irinotecan/Temozolomide With Temsirolimus (NSC# 683864) or Chimeric 14.18 Antibody (Ch14.18) (NSC# 764038) in Children With Refractory, Relapsed or Progressive Neuroblastoma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 26 Oct 2022

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At a glance

Most Recent Events

  • 21 Oct 2022 Status changed from active, no longer recruiting to completed.
  • 05 May 2021 According to a United Therapeutics Corporation media release, following comments from the FDA ahead of our planned supplemental biologics license application submission, the company elected to discontinue development of Unituxin in relapsed/refractory neuroblastoma.
  • 29 Jul 2020 According to a United Therapeutics Corporation media release, the company met with the FDA in April of this year to discuss the content needed to support a supplemental biologics license application (BLA) and they are working with Children's Oncology Group to secure additional information ahead of a potential supplemental BLA.

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