A Phase I/IIa Study of Decitabine in Combination With Genistein in Pediatric Patients With Relapsed or Refractory Solid Tumours and Leukemia
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
View this trial on ClinicalTrials.gov
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