Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumours

Official Title

Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumours

Summary:

This study will evaluate dose escalation of melatonin in pediatric oncology patients with relapsed solid tumours. The purpose of this study is to determine the safety of melatonin at a dose up to 20 mg daily, as well as to determine the maximum tolerated dose of melatonin.

Trial Description

Primary Outcome:

  • Maximum tolerated daily dose of melatonin.
Secondary Outcome:
  • Number of dose limiting toxicities during 8 weeks of melatonin therapy.
  • Peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of Melatonin.
  • The quantity of cytokines will be measured during 8 weeks of melatonin therapy.
  • Change from Baseline in weight after 8 weeks of therapy.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society