Canadian Cancer Trials Group Bulletins

Trial Management Group

Trial Activation

The Investigational New Drug Program is very pleased to announce the central activation of Canadian Cancer Trials Group's first pediatric trial.

IND.203 is a phase I study of SB939 in pediatric patients with refractory solid tumours and leukemia. This study will run in eight centres across Canada - Halifax, Ste-Justine, Ottawa, Toronto, Winnipeg, Calgary, Edmonton, and Vancouver.

In the Spring of 2009, Canadian Cancer Trials Group and C17, a research group made up a network of pediatric oncology centres in Canada, discussed ways the two groups could collaborate. Over the years, C17 has been very active in the Children┐s Oncology Group (COG) and has participated in numerous phase I, II and III studies through COG. Its participation has facilitated Canadian enrollment in COG studies by offering the infrastructure to support regulatory submission of all COG clinical trials to Health Canada, including phase I studies.

However, despite C17's active engagement with COG, in Canada, phase I activity is limited to just two centres (the Hospital for Sick Kids in Toronto and the Hopital Ste-Justine in Montreal), and there is limited phase II activity outside of trials that might arise through COG, despite the strong clinical research capacity. Additionally:

o Pediatric cancers are often neglected in early drug development because of their rarity and pharmaceutical company concerns about risk in this population.

o Basic research has identified numerous genetic mutations and other changes in pediatric cancers which may make them ideal tumour types in which to assess the impact of novel targeted therapeutics already under study in adult tumours.

o Canadian Cancer Trials Group IND Program has ready access to a number of agents through pharmaceutical firms amongst which are several of scientific importance to the pediatric community.

In view of this, the IND Program at the Canadian Cancer Trials Group and C17 have created a new program within the IND Program for pediatric phase I and II studies. The hope is to activate 1-2 new trials each year.

IND.203 is the first.