Clinical Trials

Clinical Trials Unit

Team members:

Associate Professor David Ziegler, Head, Clinical Trials Unit
Dr Draga Barbaric, COG Principal Investigator
Dr Toby Trahair, SIOPEN Principal Investigator
Grace Wong, Clinical Research Manager
Rachel Shirt, Clinical Trials Nurse
Lily Wong, Clinical Research Associate
Archana Rajasekharan Nair, Clinical Research Associate
Shelley Burnett, Clinical Research Associate
Renee Hou, Clinical Research Associate
Jessica Goh, Clinical Trials Assistant 

KOALA: Kids Oncology and Leukaemia triAls

Team Members:

Emma McCormack, Kids Cancer Alliance Clinical Trials Project Manager
Lily Wong, Clinical Research Associate
Sarah Piplica, Children's Cancer Foundation National Clinical Trial Coordinator

Aims and purpose

The KCC Clinical Research Unit is focused on being at the forefront of paediatric oncology clinical research through participation in a broad range of Phase I, Phase II and Phase III Clinical Trials.

The Clinical Trials Team collaborates with several national and international collaborative trial groups and pharmaceutical companies in order to facilitate this access to such a broad range of clinical trials for children with cancer. We also focus on the development of “home-grown” investigator initiated trials that focus on the translation of preclinical research to the bedside to directly benefit children with cancer. They support the research efforts of the department by ensuring that all clinical trials are run in accordance with national and international ethical and regulatory standards including ICH-GCP and TGA guidelines.

KOALA – Kids Oncology and Leukaemia triAls has been set up by the Kids Cancer Alliance to facilitate bringing together discoveries from across NSW. KOALA is a Clinical Trials Centre for Childhood Cancer, based within the Kids Cancer Centre, Sydney Children’s Hospital, Randwick. It functions as a central clinical trials office for paediatric oncology trials with a particular emphasis on early phase trials. KOALA is recognised as the only trials centre with expertise in the central co-ordination of early phase paediatric oncology trials in Australia. 

Research:

The Clinical Trials Team collaborates on an international stage with many leading research collaborative groups in order to facilitate the implementation of all phases of clinical trials in the department. The team aims to build upon existing collaborations and to seek out potential new partnerships to further strengthen our clinical trials program.

Dr Draga Barbaric is the Australian Study Chair for ‘Study 9’ a Phase III international multicentre randomised clinical trial for children with newly diagnosed Acute Lymphoblastic Leukaemia (ALL) developed by the BFM-AIEOP group. Over the last 30 years, the BFM-AIEOP series of studies have led to incremental improvements in survival, so that today 80% of children with ALL are cured. Study 9 aims to build upon this success. ALL is the most common paediatric malignancy constituting about 25% of all childhood cancers. In Australia, about 150 children are diagnosed with ALL annually and just over half of these will be enrolled on Study 9. The KCC Clinical Trials Team has assumed the role of the National Coordinating Centre for Study 9 and will oversee the conduct of the trial for all Australian sites. 

A second area of focus for the team is Phase I/II studies. Up to 25% of children with cancer have a disease that is refractory to treatment or recurrent and the majority of these children will not survive. Phase I/II clinical trials represent a real treatment option for these patients and are central to the translation of basic science discoveries into new clinical treatments. **Link to Early phase clinical trials**

The Clinical Trials Unit at any time has 30-40 clinical trials open for patient enrolment.

The KCC actively collaborates with the following national and international collaborative trials groups on a large number of clinical trials:

  • Australia and New Zealand Children’s Haematology Oncology Groups (ANZCHOG)
  • Therapeutic Advances in Leukemia (TACL)
  • Children’s Oncology Group (COG)
  • International Society of Paediatric Oncology (SIOP)
  • New Approaches to Neuroblastoma Therapy (NANT)
  • German and Italian International Leukaemia group; AIEOP-BFM (Associazione Italiana Ematologia Oncologia Pediatrica - Berlin-Franklin-Munster).