Improving Development of and Patient Access to Early Phase Pediatric Cancer Clinical Trials

While an empiric strategy of evaluation of chemotherapeutic agents has resulted in impressive gains in survival of children with cancer, it is clear that the constantly increasing number of new agents requires a strategy in which early phase clinical trails are developed only when justified by strong pre-clinical laboratory data. Seattle Children's Hospital (SCH) and the Seattle Cancer Consortium (SCH, University of Washington, Fred Hutchinson Cancer Research Center) have a strong record of focused preclinical laboratory and early phase institutional evaluation of new cancer therapies, and of successful transition of these therapies to national consortia for definitive assessment.  We propose expansion of our pediatric cancer early phase testing program infrastructure to enable rapid initial clinical evaluation of preclinically promising therapies. We believe that by conducting such preliminary trials at Seattle Children's Hospital we will accelerate the development of treatments based on robust preclinical data, which can potentially be transitioned to the larger multiinstitutional cooperative groups for more definitive evaluation.  
 

We also plan to address barriers to participation in early phase pediatric cancer trials by patients  receiving their primary cancer care at cancer programs in the Northwest other than SCH.  Improving access for and potential participation of such patients is important for two reasons:1) the major factor limiting timely conduct of early phase pediatric cancer trials is the paucity of eligible patients; and 2) these patients are effectively unable to access what might be a reasonable treatment option.