|The Canadian Cancer Trials Group is very pleased to announce activation of the Group's second pediatric trial.
Canadian Cancer Trials Group IND.212 -- A Pilot Study of Imetelstat Given Intravenously on Day 1 and 8 of a 21 Day Schedule alone and With Standard 13-cis-retinoic acid in Children with Recurrent and/or Refractory Neuroblastoma -- was centrally activated July 30, 2013.
The primary objectives of the trial are to:
- Confirm the feasibility of administering imetelstat given at the recommended pediatric dose as determined in the Children's Oncology Group Study ADVL1112 (a phase I study of imetelstat, a telomerase inhibitor, in children with recurrent or refractory solid tumours and lymphoma), alone and in combination with 13-cis-retinoic acid;
- Assess the impact of imetelstat on hematopoietic stem cells and neuroblastoma tumour initiating cells; and,
- The correlation of tumour and plasma C-circles.
- The role of plasma C-circles as a tumour biomarker for alternative lengthening of telomeres (ALT).
- Changes in plasma C-circles induced by treatment with imetelstat.