Canadian Cancer Trials Group Bulletins

Trial Management Group

Trial Activation

Canadian Cancer Trials Group IND.218 -- A Study of Vinblastine and Temsirolimus in Pediatric Patients with Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours -- was centrally activated on June 2.

The primary objective of the trial is to determine the recommended phase II dose of the combination of vinblastine and temsirolimus (administered as a weekly intravenous dose) in children with recurrent or refractory solid tumours including central nervous system tumours and lymphoma and to describe the associated toxicities in children.

Secondary objectives are to:
  • Assess the anti-tumour activity of vinblastine in combination with temsirolimus in pediatric solid tumours;
  • Characterize the pharmacokinetics of temsirolimus in whole blood (including its principal metabolite sirolimus) when administered in combination with vinblastine; and,
  • Assess the pharmacodynamics of this regimen by evaluating change in plasma cytokines and angiogenic factors and mTOR inhibition in peripheral mononuclear cells as a biomarker of target inhibition.