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
Latest Information Update: 26 Oct 2022
At a glance
- Drugs Dinutuximab (Primary) ; Irinotecan (Primary) ; Sargramostim (Primary) ; Sargramostim (Primary) ; Temozolomide (Primary) ; Temsirolimus (Primary)
- Indications Neuroblastoma
- Focus Therapeutic Use
- 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.