Phase I/II a Study of Decitabine in Combination With Genistein in Pediatric Relapsed or Refractory Malignancies

Official Title

A Phase I/IIa Study of Decitabine in Combination With Genistein in Pediatric Patients With Relapsed or Refractory Solid Tumours and Leukemia

Summary:

This Phase I/IIa study will test the combination of the epigenetic drug decitabine with the isoflavone genistein in children with leukemias and solid tumours. For the phase I study, the maximum tolerated dose will be evaluated in pediatric patients with relapsed or refractory leukemia and solid tumours. For the phase II study, only patients with relapsed or refractory leukemias will be included. To further evaluate the treatment efficacy and gain further insight into action of these drugs, the DNA methylation levels before and after treatment for all participants, pharmacokinetics parameters such as through level for decitabine and through and peak level for genistein will be measured. Pharmacogenomics testing for decitabine will be performed prior to cycle 1 of treatment. Decitabine will be administered over a 24 hours infusion on day 1 of cycle (28 days) and genistein will be taken orally twice daily from day 2 to 21, followed by a 7 days rest period.

Trial Description

Primary Outcome:

  • Maximum tolerated dose of the combination of intravenous decitabine with oral genistein for children with refractory or recurrent solid malignancies and leukemia
  • Number of participants with adverse events as a measurement of safety and tolerability of the combination of intravenous decitabine with oral genistein in children.
  • Clinical benefit of the combination of intravenous decitabine with oral genistein in phase IIa of the study measure by either volumetric MRI for solid tumour or by bone marrow aspiration or biopsy for leukemia) at the end of cycle 2, 4, 6, 9 and 12.
Secondary Outcome:
  • Plasma concentration of decitabine and genistein during cycle 1 and 2 (just in Phase I).
  • DNA methylation levels in selected gene promoters before and after treatment.
  • Quality of life assess through Peds Quality of Life Cancer module, Peds Quality of Life Fatigue module, Reported Health status 15-items, Pain Visual Analogue Scale, Distress Rating Scale, Expectations and McGill Quality of Life Questionnaire

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